Significant Difference In Weight Change Research Articles

DEFINE: A Prospective, Randomized, Phase 4 Trial to Assess a Protease Inhibitor-based Regimen Switch Strategy to Manage Integrase Inhibitor-related Weight Gain.

Integrase strand transfer inhibitor (InSTI)-based antiretroviral therapies have been associated with greater weight gain in people living with HIV versus on protease inhibitor (PI)-based regimens. The DEFINE study investigated whether switching from an InSTI- to a PI-based regimen could mitigate/reverse weight gain. DEFINE (NCT04442737) was a randomized, 48-week, open-label, prospective, phase 4 study in virologically suppressed adults with HIV-1 and ≥10% weight gain on InSTI+tenofovir alafenamide (TAF)/emtricitabine (FTC) (<36 months pre-screening). Participants either switched immediately to darunavir/cobicistat/emtricitabine/TAF (D/C/F/TAF) or continued InSTI+TAF/FTC during Weeks 0-24 then switched to D/C/F/TAF for Weeks 24-48. The primary endpoint was least squares (LS) mean (95% confidence interval [CI]) percent weight change from baseline to Week 24. Overall, 103 adults were randomized (D/C/F/TAF, n=53; InSTI+TAF/FTC, n=50); 30% female; 61% Black/African American. No significant difference in weight change was observed at Week 24 (LS mean change: D/C/F/TAF, 0.63% [95%CI: -0.44, 1.70] vs InSTI+TAF/FTC, -0.24% [-1.35, 0.87]; p=0.24); however, a trend towards weight loss was observed with extended time post-ARV switch to D/C/F/TAF (baseline to Week 48, -0.36% [-1.77, 1.06]), particularly in subgroups at higher weight gain risk (eg, females, Black/African Americans). Metabolic endpoints paralleled weight change over time. D/C/F/TAF was well tolerated, with comparable virologic efficacy between arms. While no significant change in body weight was observed at 24 weeks after switching from InSTI+TAF/FTC to D/C/F/TAF among adults with weight gain, a trend towards weight loss emerged with longer time post-ARV switch, supporting further investigation of antiretroviral selection/switch for weight management.

Digital Biohacking Approach to Dietary Interventions: A Comprehensive Strategy for Healthy and Sustainable Weight Loss.

The rising obesity epidemic requires effective and sustainable weight loss intervention strategies that take into account both of individual preferences and environmental impact. This study aims to develop and evaluate the effectiveness of an innovative digital biohacking approach for dietary modifications in promoting sustainable weight loss and reducing carbon footprint impact. A pilot study was conducted involving four participants who monitored their weight, diet, and activities over the course of a year. Data on food consumption, carbon footprint impact, calorie intake, macronutrient composition, weight, and energy expenditure were collected. A digital replica of the metabolism based on nutritional information, the Personalized Metabolic Avatar (PMA), was used to simulate weight changes, plan, and execute the digital biohacking approach to dietary interventions. The dietary modifications suggested by the digital biohacking approach resulted in an average daily calorie reduction of 236.78 kcal (14.24%) and a 15.12% reduction in carbon footprint impact (-736.48 gCO2eq) per participant. Digital biohacking simulations using PMA showed significant differences in weight change compared to actual recorded data, indicating effective weight reduction with the digital biohacking diet. Additionally, linear regression analysis on real data revealed a significant correlation between adherence to the suggested diet and weight loss. In conclusion, the digital biohacking recommendations provide a personalized and sustainable approach to weight loss, simultaneously reducing calorie intake and minimizing the carbon footprint impact. This approach shows promise in combating obesity while considering both individual preferences and environmental sustainability.

Sedative and hypnotic effects of the saponins from a traditional edible plant Liriope spicata Lour. in PCPA-induced insomnia mice

Ethnopharmacological relevanceLiriope spicata Lour., a species listed in the catalogue of ‘Medicinal and Edible Homologous Species’, is traditionally used for the treatment of fatigue, restlessness, insomnia and constipation. Aim of the studyThis study is aimed to evaluate the sedative and hypnotic effect of the saponins from a natural plant L. spicata Lour. in vivo. Materials and methodsThe total saponin (LSTS) and purified saponin (LSPS) were extracted from L. spicata, followed by a thorough analysis of their major components using the HPLC-MS. Subsequently, the therapeutic efficacy of LSTS and LSPS was evaluated by the improvement of anxiety and depression behaviors of the PCPA-induced mice. ResultsLSTS and LSPS exhibited similar saponin compositions but differ in their composition ratios, with liriopesides-type saponins accounting for a larger proportion in LSTS. Studies demonstrated that both LSTS and LSPS can extend sleep duration and immobility time, while reducing sleep latency in PCPA-induced mice. However, there was no significant difference in weight change among the various mice groups. Elisa results indicated that the LSTS and LSPS could decrease levels of NE, DA, IL-6, and elevate the levels of 5-HT, NO, PGD2 and TNF-α in mice plasma. LSTS enhanced the expression of neurotransmitter receptors, while LSPS exhibited a more pronounced effect in regulating the expression of inflammatory factors. In conclusion, the saponins derived from L. spicata might hold promise as ingredients for developing health foods with sedative and hypnotic effects, potentially related to the modulation of serotonergic and GABAAergic neuron expression, as well as immunomodulatory process.

Impact of Weight Concern on Post-Cessation Weight Management, Smoking Cessation, and Program Engagement.

Weight concern is a barrier to smoking cessation. We examined the impact of weight concern on post-cessation weight gain, abstinence and program engagement. Randomized-controlled trial. Telephone-based and group-based intervention sessions. 305 participants were randomized and analyzed. Participants were randomized to receive a self-guided intervention, a weight loss intervention, or a weight stability intervention prior to all receiving the same smoking cessation intervention. Level of weight concern on three measures, point-prevalence abstinence, weight change, and session attendance at 12months. Continuous and discrete outcomes were compared between weight-concerned and non-weight-concerned participants using two-sample t-tests and chi-square tests respectively. There were no significant differences in weight change (range: +1.77, -1.91kg) when comparing weight-concerned and non-weight-concerned participants. Point-prevalence abstinence ranged from 36% to 64%, with no differences by condition based on level of weight concern. There were no significant differences in session attendance by weight concern (Weight sessions: 50-70%, Smoking cessation sessions: 41-56%, Booster sessions: 28-45%). Weight concern, on all measures, significantly decreased between screening and 2months (after the weight management intervention), for most of the comparisons made overall and by condition. It may not be necessary to screen for weight concerns in smoking cessation and/or post-cessation weight management programs, as the trial interventions were beneficial regardless of weight concern.

Effect of planned pauses versus continuous energy restriction on weight loss and attrition: a systematic review.

The objective of this study was to investigate whether pausing a weight loss program for a defined period of time could enhance weight loss and reduce attrition. Five databases and two trial registries were searched from inception to July 2023. Randomized-controlled trials of adults with overweight and/or obesity were included if they compared planned-pause interventions with continuous energy restriction (CER), usual care, or a minimal intervention. To be included, the weight loss intervention must have incorporated a pause of at least 1 week. Pooled mean differences for weight change and risk ratios for attrition were calculated using random-effects meta-analyses. Nine intervention arms (N = 796 participants, 77% female) were included. Pooled results did not detect a significant difference in weight change between planned pauses and CER interventions at the end of the active intervention at a median 26 weeks (planned pauses vs. CER mean: -7.09 vs. -7.0 kg; mean difference: -0.09 kg; 95% CI: -1.10 to 0.93) or at final follow-up at a median 52 weeks (planned pauses vs. CER mean: -6.91 vs. -6.19 kg; mean difference: -0.72 kg; 95% CI: -2.92 to 1.48). There was no difference in attrition between planned pauses and CER interventions at the end of the active intervention (risk ratio: 1.20, 95% CI: 0.82 to 1.75) or at final follow-up (risk ratio: 1.04, 95% CI: 0.89 to 1.22). Planned pauses were consistently found to be no more or less effective than CER for weight loss or attrition.

1985. A Prospective, Randomized Trial to Assess a Protease Inhibitor–based Regimen Switch Strategy to Manage Integrase Inhibitor–related Weight Gain

Abstract Background Integrase inhibitor (INI)–based antiretroviral (ARV) therapies are associated with greater weight gain than non-nucleoside reverse transcriptase inhibitor– or boosted protease inhibitor–based regimens, disproportionately affecting Black and Hispanic individuals and women. The mechanisms underlying this weight gain are unknown, and there are no prospective, randomized data exploring the impact of switching ARV classes to mitigate or reverse ARV-related weight gain. Methods DEFINE (ClinicalTrials.gov: NCT04442737) is a randomized (1:1), prospective, 48-week, active-controlled, open-label, multicenter phase 4 study evaluating switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) versus continuing INI+TAF/emtricitabine (FTC) in virologically-suppressed HIV-1–infected adults who had ≥10% weight gain while on the INI-based regimen. The primary objective was to assess percent change in body weight from baseline to Week 24 in both arms. The primary endpoint was analyzed using a mixed model for repeated measures in the intent-to-treat set of randomized participants who had received ≥1 dose of study drug. Secondary endpoints included change in body mass index (BMI), waist circumference (WC), efficacy, and safety. Data through Week 24 are reported. Results Overall, 103 adults were randomized to D/C/F/TAF (n=53) or continued INI+TAF/FTC (n=50); 30% were female and 61% were Black/African American, with median 27.0 months virologic suppression on INI+TAF/FTC (Table 1). Discontinuation rates were low and similar between arms. At Week 24, there was no significant difference in percent change in body weight from baseline between the D/C/F/TAF and INI+TAF/FTC arms (Figure). Most participants in each arm had body weight changes of ≤±3% and remained within baseline BMI and WC categories. Percent body weight changes for key subgroups are shown in Table 2. Switching to D/C/F/TAF was safe and well tolerated, and efficacy was maintained.Table 1.Demographics and Baseline Characteristics (ITT Set)BMI, body mass index; D/C/F/TAF, darunavir/cobicistat/emtricitabine/tenofovir alafenamide; FTC, emtricitabine; INI, integrase inhibitor; ITT, intent-to-treat; TAF, tenofovir alafenamide. *One participant in the D/C/F/TAF arm did not have available data. Percent Change From Baseline in Body Weight Over Time for Participants Who Switched to D/C/F/TAF and Those Who Continued Their Current INI+TAF/FTC Regimen (ITT Set) D/C/F/TAF, darunavir/cobicistat/emtricitabine/tenofovir alafenamide; FTC, emtricitabine; INI, integrase inhibitor; ITT, intent-to-treat; LS, least-squares; TAF, tenofovir alafenamide. LS means percent changes in body weight were calculated in the ITT set of randomized participants who had received ≥1 dose of study drug using a mixed model for repeated measures, in which the dependent variable was percent change from baseline in body weight; independent variables were treatment, baseline body mass index, sex, and race (Black/African American vs non–Black/African American); and visits were repeated measures. Participants in the ITT set with baseline records and ≥1 postbaseline record were included. Conclusion There was no significant difference in weight change through 24 weeks after switching from an INI-based regimen to D/C/F/TAF in adults with INI-related weight gain. Additional analyses are ongoing, including follow up through Week 48 and evaluation of changes in biomarkers and body composition (DEXA).Table 2.Percent Change From Baseline in Body Weight at Week 24 Among Key Subgroups (ITT Set)BMI, body mass index; D/C/F/TAF, darunavir/cobicistat/emtricitabine/tenofovir alafenamide; FTC, emtricitabine; INI, integrase inhibitor; ITT, intent-to-treat; TAF, tenofovir alafenamide. Disclosures William R. Short, MD, Gilead Sciences: Advisor/Consultant|ViiV: Advisor/Consultant|ViiV: Honoraria Moti Ramgopal, MD, FACP, FIDSA, AbbVie: Honoraria|Gilead Sciences, Inc.: Advisor/Consultant|Gilead Sciences, Inc.: Honoraria|Janssen Pharmaceuticals: Advisor/Consultant|Janssen Pharmaceuticals: Honoraria|Merck: Advisor/Consultant|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Honoraria Debbie P. Hagins, MD, FAPCR, AAHIVS, Janssen Pharmaceuticals: Advisor/Consultant Johnnie Lee, MD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds Richard Bruce Simonson, BS, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds Tien-Huei Hsu, PhD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds Ping Xu, PhD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds David Anderson, MD, Janssen Pharmaceuticals: Employee|Janssen Pharmaceuticals: Stocks/Bonds

Oral Furosemide and Hydrochlorothiazide/Amiloride versus Intravenous Furosemide for the Treatment of Resistant Nephrotic Syndrome

Background: Data on diuretic treatment in nephrotic syndrome (NS) are scarce. Our goal was to assess the non-inferiority of the combined oral diuretics (furosemide/hydrochlorothiazide/amiloride) compared to intravenous (i.v.) furosemide in patients with NS and resistant edema. Methods: We conducted a prospective randomized trial on 22 patients with resistant nephrotic edema (RNE), defined as hypervolemia and a FENa &lt; 0.2%. Based on a computer-generated 1:1 randomization, we assigned patients to receive either intravenous furosemide (40 mg bolus and then continuous administration of 5 mg/h) or oral furosemide (40 mg/day) and hydrochlorothiazide/amiloride (50/5 mg/day) for a period of 5 days. Clinical and laboratory measurements were performed daily. Hydration status was assessed by bioimpedance on day 1 and at the end of day 5 after treatment initiation. The primary endpoint was weight change from baseline to day 5. Secondary endpoints were hydration status change measured by bioimpedance and safety outcomes (low blood pressure, severe electrolyte disturbances, acute kidney injury and worsening hypervolemia). Results: Primary endpoint analysis showed that after 5 days of treatment, there was a significant difference in weight change from baseline between groups [adjusted mean difference: −3.33 kg (95% CI: −6.34 to −0.31), p = 0.03], with a higher mean weight change in the oral diuretic treatment group [−7.10 kg (95% CI: −18.30 to −4.30) vs. −4.55 kg (95%CI: −6.73 to −2.36)]. Secondary endpoint analysis showed that there was no significant difference between groups regarding hydration status change [adjusted mean difference: −0.05 L (95% CI: −2.6 to 2.6), p = 0.96], with a mean hydration status change in the oral diuretic treatment group of −4.71 L (95% CI: −6.87 to −2.54) and −3.91 L (95% CI: −5.69 to −2.13) in the i.v. diuretic treatment group. We observed a significant decrease in adjusted mean serum sodium of −2.15 mmol/L [(95% CI: −4.25 to −0.05), p = 0.04]), favored by the combined oral diuretic treatment [−2.70 mmol/L (95% CI: −4.89 to −0.50) vs. −0.10 mmol/L (95%CI: −1.30 to 1.10)]. No statistically significant difference was observed between the two groups in terms of adverse events. Conclusions: A combination of oral diuretics based on furosemide, amiloride and hydrochlorothiazide is non-inferior to i.v. furosemide in weight control of patients with RNE and a similar safety profile.

FRI639 Effect Of Early Initiation Of GLP-1 RAs On Weight Reduction Among People With Type 2 Diabetes

Abstract Disclosure: C. Chinthammit: Employee; Self; Eli Lilly &amp; Company. Stock Owner; Self; Eli Lilly &amp; Company. R. Mody: Employee; Self; Eli Lilly &amp; Company. Stock Owner; Self; Eli Lilly &amp; Company. D. Liu: Employee; Self; Eli Lilly &amp; Company. Stock Owner; Self; Eli Lilly &amp; Company. B.D. Benneyworth: Employee; Self; Eli Lilly &amp; Company. Stock Owner; Self; Eli Lilly &amp; Company. C. Vallarino: Employee; Self; Eli Lilly &amp; Company. Stock Owner; Self; Eli Lilly &amp; Company. Early initiation of glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy is associated with improved glycemic outcomes among people with type 2 diabetes (T2D). However, there is limited real-world evidence suggesting a similar impact on weight reduction. This study examined the relationship between timing of initiation of a GLP-1 RA and magnitude of weight reduction. This retrospective cohort study used data from the Optum® de-identified Market Clarity database from April 1, 2014, to March 31, 2020. Adults with T2D who initiated GLP-1 RA treatment during the index period, April 1, 2016 - March 31, 2019, were included. Date of first prescription was defined as index date. Patients were required to have continuous enrollment ≥2 years pre-index and 1-year post-index; have ≥1 weight and BMI values during the 6-month baseline and 1-year post-index periods; baseline BMI ≥25 kg/m2, and ≥1 pre-index oral antihyperglycemic drug (OAD) claim. Timing of GLP-1 RA initiation was proxied by the number of classes of OADs (1 OAD, 2 OADs, 3+ OADs) prescribed in the pre-index period, with fewer OADs indicating initiation of GLP-1 RA earlier in disease progression. Outcomes included weight change from baseline to 6 and 12 months of follow-up and proportion of patients achieving ≥5% weight reduction after GLP-1 RA initiation. In order to control for confounding, multivariable analyses (MVA) used weights based on propensity scores to examine the relationship between timing of GLP-1 RA initiation and post-index weight outcomes. Of the 4,194 patients evaluated, 1,317 (31.4%), 1,480 (35.3%), and 1,397 (33.3%) were classified into the 1 OAD, 2 OAD, and 3+ OAD cohorts, respectively. Baseline characteristics were fairly uniform across the three cohorts, but the 1 OAD cohort had more females (59.5%) than 2 OAD (51.1%) and 3+ OAD (44.7%), and a higher mean baseline BMI (1 OAD: 38.7 kg/m2; 2 OAD: 37.4 kg/m2; 3+ OAD: 36.4 kg/m2; p&amp;lt;0.0001). The 1 OAD cohort experienced a larger magnitude of weight reduction from baseline to 6 months (-3.0 kg) and 12 months (-3.1 kg) of follow-up vs 2 OAD (-2.4 kg and -2.7 kg) and 3+ OAD (-2.3 kg and -2.4 kg). The 1 OAD cohort had the largest proportion of patients who achieved ≥5% weight reduction at 6 months (24.9%) and 12 months of follow-up (25.5%) vs 2 OAD (19.7% and 22.1%) and 3+ OAD (21.4% and 20.6%). MVA showed that earlier GLP-1 RA initiation (1 OAD) was associated with greater weight reduction at 6 months (p=0.008) and 12 months (p=0.012) of follow-up compared to later initiation (3+ OAD). No significant differences in weight change were observed between the 2 OAD and 3+ OAD cohorts. This study showed that earlier initiators (1 OAD) of a GLP-1 RA experienced a larger magnitude of weight reduction than later initiators (3+ OADs). The research underscores the importance of further exploring the potential impact of early T2D treatment on weight reduction. Presentation: Friday, June 16, 2023

Evaluation of a combined, online intervention for binge-type eating disorders and high body weight in young adults

BackgroundBinge-type eating disorders (EDs; i.e., bulimia nervosa, binge eating disorder) are common among young adults with high body weight, yet few interventions target both conditions. This study tested an online guided self-help intervention that provided cognitive behavioral therapy (CBT) tools for EDs and behavioral weight loss (BWL) content to young adults with binge-type EDs and high body weight. Method60 adults aged 18–39 with clinical/subclinical binge-type EDs and high body weight were randomized to a combined condition or a CBT-only condition. Participants received self-help content for 8 weeks and self-reported ED attitudes, frequency of binge eating and compensatory behaviors, and weight at baseline, 4-weeks, and 8-weeks. Linear mixed models and negative binomial models compared changes between conditions in ED attitudes, ED behaviors, and weight at each timepoint. Chi-square test and independent samples t-test compared program completion and session engagement between conditions. ResultsNo significant differences in weight change or ED symptom change emerged between the conditions. Both conditions achieved significant reductions in ED attitudes, binge episodes, and compensatory behaviors from baseline to 8-weeks (ps < .05). Neither condition demonstrated significant weight loss from baseline to 8-weeks. Program completion (47 %) and session engagement (57 %) were equally high across conditions. DiscussionBoth conditions achieved ED symptom change; however, neither condition was associated with weight change. Research is needed to identify the types of strategies and doses of BWL that promote clinically significant weight and ED symptom change in young adults.

Weight loss in nintedanib-treated patients with idiopathic pulmonary fibrosis

Nintedanib is approved for the treatment of idiopathic pulmonary fibrosis (IPF). Weight loss is recognized as an adverse event during nintedanib treatment, and is a common complication exploitable as a prognostic indicator of IPF. Here, we report a single-center, retrospective cohort study to assess body weight changes during nintedanib therapy in patients with IPF. Sixty-one patients treated with nintedanib for >6 months were included (45 males, mean age ± standard deviation 73.1 ± 7.4 years). Baseline body weight and body mass index were 60.1 ± 12.0 kg and 23.2 ± 3.5 kg/m2, respectively. Mean weight loss during the first 6 months of nintedanib treatment was significant (−3.2 ± 3.4 kg, p < 0.0001) with Common Terminology Criteria for Adverse Events (CTCAE) grades 0,1,2 or 3 of 30, 17, 13 and 1, respectively. Pulmonary function test records 6 months before nintedanib administration were available in a subset of patients (n = 40). Significant differences in weight change over the 6 months before-vs-after nintedanib administration were also observed in these patients [mean differences −2.5 ± 3.4 kg, 95% confidence interval (CI) −3.6, −1.4, p < 0.0001]. Multivariate analysis showed that only baseline body weight was significantly associated with weight loss of CTCAE grade ≧2 (odds ratio 0.921, 95% CI 0.854, 0.994). Median follow-up from starting nintedanib was 34.8 months. There was a significant difference in overall survival between patients with CTCAE grade ≧2-vs-grade<2 (median survival of 25.5 months and 55.2 months, p = 0.014). In the model adjusting for age, sex and lung function, weight loss CTCAE grade ≧2 was an independent predictor for all-cause mortality (hazard ratio 2.448, 95% CI 1.080–5.551). In conclusion, weight loss is an important issue for the management of patients with IPF treated with nintedanib.

Rugby Fans in Training New Zealand (RUFIT NZ): a randomized controlled trial to assess the effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs

BackgroundA healthy lifestyle program that appeals to, and supports, overweight and obese New Zealand (NZ) European, Māori (indigenous) and Pasifika men to achieve weight loss is urgently needed. A pilot program inspired by the successful Football Fans in Training program but delivered via professional rugby clubs in NZ (n = 96) was shown to be effective in weight loss, adherence to healthy lifestyle behaviors, and cardiorespiratory fitness in overweight and obese men. A full effectiveness trial is now needed.AimsTo determine the effectiveness and cost effectiveness of Rugby Fans In Training-NZ (RUFIT-NZ) on weight loss, fitness, blood pressure, lifestyle change, and health related quality of life (HRQoL) at 12- and 52-weeks.MethodsWe conducted a pragmatic, two-arm, multi-center, randomized controlled trial in NZ with 378 (target 308) overweight and obese men aged 30–65 years, randomized to an intervention group or wait-list control group. The 12-week RUFIT-NZ program was a gender-sensitised, healthy lifestyle intervention delivered through professional rugby clubs. Each intervention session included: i) a 1-h workshop-based education component focused on nutrition, physical activity, sleep, sedentary behavior, and learning evidence-based behavior change strategies for sustaining a healthier lifestyle; and 2) a 1-h group-based, but individually tailored, exercise training session. The control group were offered RUFIT-NZ after 52-weeks. The primary outcome was change in body weight from baseline to 52-weeks. Secondary outcomes included change in body weight at 12-weeks, waist circumference, blood pressure, fitness (cardiorespiratory and musculoskeletal), lifestyle behaviors (leisure-time physical activity, sleep, smoking status, and alcohol and dietary quality), and health-related quality of life at 12- and 52-weeks.ResultsOur final analysis included 200 participants (intervention n = 103; control n = 97) who were able to complete the RUFIT-NZ intervention prior to COVID-19 restrictions. At 52-weeks, the adjusted mean group difference in weight change (primary outcome) was -2.77 kg (95% CI -4.92 to -0.61), which favored the intervention group. The intervention also resulted in favorable significant differences in weight change and fruit and vegetable consumption at 12-weeks; and waist circumference, fitness outcomes, physical activity levels, and health-related quality of life at both 12 and 52 weeks. No significant intervention effects were observed for blood pressure, or sleep. Incremental cost-effective ratios estimated were $259 per kg lost, or $40,269 per quality adjusted life year (QALY) gained.ConclusionRUFIT-NZ resulted in sustained positive changes in weight, waist circumference, physical fitness, self-reported physical activity, selected dietary outcomes, and health-related quality of life in overweight/obese men. As such, the program should be recommended for sustained delivery beyond this trial, involving other rugby clubs across NZ.Trial registrationAustralia New Zealand Clinical Trials Registry, ACTRN12619000069156. Registered 18 January 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376740 Universal Trial Number, U1111-1245–0645.

Effectiveness of digital and remote provision of the Healthier You: NHS Diabetes Prevention Programme during the COVID-19 pandemic.

To assess weight change in the Healthier You: NHS Diabetes Prevention Programme (NHS DPP) delivered via video conferencing (remote) sessions or delivered via specific digital interventions through apps or websites, during the COVID-19 pandemic compared to group-based face-to-face interventions, pre-pandemic. Prospectively collected national service-level data relating to individuals with non-diabetic hyperglycaemia (HbA1c 42-47 mmol/mol (6.0%-6.4%) or fasting plasma glucose 5.5-6.9 mmol/L) referred to the NHS DPP from June 2016 to March 2022. Between March 2020 and March 2022, 335,961 people were referred to the programme and were offered a choice of remote or digital intervention. This was preceded by 556,793 people referred to the face-to-face programme between June 2016 and February 2022. Uptakes to intervention sessions were 47% for those offered a choice and 39% for face-to-face. Remote and digital participants were significantly younger (60 and 56 vs. 65 years) and heavier (86.1kg and 91.0kg vs. 84.1kg) compared to face-to-face. Weight change was assessed for 42,407 remote, 7699 digital and 97,205 face-to-face participants with sufficient time to have finished the programme and no missing data. Mean weight losses for participants attending at least one intervention session were: 2.40 (2.36-2.44) kg, 2.59 (2.49-2.68) kg and 2.01 (1.98-2.04) kg for remote, digital and face-to-face participants respectively. Corresponding mean weight losses for those who completed the programme were: 3.24 (3.19-3.30) kg, 4.76 (4.60-4.92) kg and 3.04 (3.00-3.07) kg. There were no significant differences in weight change between interventions by ethnicity and deprivation. Weight losses achieved through remote and digital interventions were greater than those previously achieved through face-to-face interventions, without evidence of exacerbation of health inequalities.

The Microanatomical Study of Effect of Alkaloid Isolate of Dioscorea Bulbifera Bulbis on Cyclophosphamide Induced Testicular Damage in Adult Male Wistar Rats

Cyclophosphamide is a synthetized drug and alkylating agent used for treating cancer. In this research, cyclophosphamide's effect on the testicles of adult male Wistar rats will be assessed, as well as the impact of alkaloid extract on the induced damage. Twenty-four healthy male wistar rats weighing between 132g to 168g of the same species of rattus Norvegicus were used. Rats were randomly assigned to 4 groups, A through D (n=7 in each). Group A was given distilled water. Group B were administered with Cyclophosphamide 150mg/ kg intra-peritoneal route for seven days. Group C was administered with Cyclophosphamide 150 mg/kg and 50 mg / kg of Alkaloid concomitantly for a week and Group D was administered Alkaloid for 7 days and then Cyclophosphamide of 150 mg /kg for 7 days. There was a significant difference in weight change, according to one way ANOVA result (F = 175.9; p &lt; 0.001), testosterone activity (F = 7.019; p = 0.0125), follicle stimulating hormone activity (F = 13.27; p = 0.0018), sperm motility (F = 11.95; p = 0.0025) in group B (cyclophosphamide only) as compared to control and across all experimental groups. Cyclophosphamide administration was observed to have a negative effect on the testicular histology and immunohistochemical results. The administration of alkaloids both concomitantly and as a pre-treatment helped to counteract the effect of the drug. In conclusion, the administration of cyclophosphamide should be strictly monitored and given in low doses alongside alkaloid to prevent toxic effect.

Effects of a Web-based Weight Management Education Program on Various Factors for Overweight and Obese Women: Randomized Controlled Trial.

Mediated diet and exercise methods yield effective short-term weight loss but are costly and hard to manage. However, web-based programs can serve many participants, offering ease of access and cost-efficiency. This study aimed to compare the effectiveness of a web-based weight management program through web-based education alone (MINE) or combined with tailored video feedback (MINE Plus) with a control (CO) group. This intervention included 60 Korean women with overweight and obesity (BMI≥23 kg/m2) aged 19 years to 39 years old. We randomly allocated 60 participants to each of 3 groups: (1) MINE group (web-based education video and self-monitoring app), (2) MINE Plus group (web-based education video, self-monitoring app, and 1:1 tailored video feedback), and (3) CO group (only self-monitoring app). Web-based education included nutrition, physical activity, psychological factors, medical knowledge for weight loss, goal setting, and cognitive and behavioral strategies. Tailored feedback aimed to motivate and provide solutions via weekly 10-minute real-time video sessions. The intervention lasted 6 weeks, followed by a 6-week observation period to assess the education's lasting effects, with evaluations at baseline, 6 weeks, and 12 weeks. A generalized linear mixed model was used to evaluate time and group interactions. In the intention-to-treat analysis including all 60 participants, there were significant differences in weight change at 6 weeks in the MINE and MINE Plus groups, with mean weight changes of -0.74 (SD 1.96) kg (P=.03) and -1.87 (SD 1.8) kg (P<.001), respectively, while no significant change was observed in the CO group, who had a mean weight increase of 0.03 (SD 1.68) kg (P=.91). After 12 weeks, changes in body weight were -1.65 (SD 2.64) kg in the MINE group, -1.59 (SD 2.79) kg in the MINE Plus group, and 0.43 (SD 1.42) kg in the CO group. There was a significant difference between the MINE and MINE Plus groups (P<.001). Significant group × time effects were found for body weight in the MINE and CO groups (P<.001) and in the MINE Plus and CO groups (P<.001), comparing baseline and 12 weeks. Regarding physical activity and psychological factors, only body shape satisfaction and health self-efficacy were associated with improvements in the MINE and MINE Plus groups (P<.001). This study found that the group receiving education and tailored feedback showed significant weight loss and improvements in several psychological factors, though there were differences in the sustainability of the effects. Korea Disease Control and Prevention Agency (KDCA) KCT0007780: https://cris.nih.go.kr/cris/search/detailSearch.do/22861.

Effects Of An Online Weight Management Program On Weight And Physical Activity Changes.

PURPOSE: To compare the effectiveness of an online weight management program through only online education(OO) or tailored video feedback with online education (OF) or control(CO). METHODS: This intervention included 60 overweight and obese Korean women aged 19 -39 years old. Participants are randomly allocated to one of three groups: (1) 20 women in OO group (online education video and self-monitoring application), (2) 20 women in OF group (online education video, self-monitoring application, and 1:1 tailored video feedback), and (3) 20 women in CO group (only self-monitoring application). Online education included nutrition, physical activity, psychological factors, and medical knowledge for weight loss, goal-setting, and cognitive/behavioral strategies. Tailored feedback helped to motivate weight loss and give solutions for weight loss through real-time video coaching once a week for 10 minutes per session. Effectiveness was assessed using repeated measure ANOVA to compare outcome changes between groups and Tukey’s post-hoc tests were performed. RESULTS: After 6-weeks, a total of 17(85%) of OO group, 17(85%) of OF group, and 19(95%) of CO group completed the post-measurement at 6 weeks. In the intention-to-treat analysis including all 60 participants, there was a significant difference in weight change at 6 weeks in OO and OF groups with a mean weight change of -0.86 kg (95%CI, -1.72 to -0.1) in OO group and -2.23 kg (95%CI, -2.93 to -1.52) in OF group, while no significant change was observed in CO group with a mean weight change of 0.08 kg (95%CI, -0.65 to 0.8). Changes in waist circumference were -2.29 cm (95% CI, -3.48 to -1.11) in OF group, -1.64 cm (95 CI, -3.14 to -0.09) in OO group, and 0.03 cm (95% CI, -1.05 to 1.11) in CO group. In the post-hoc analysis, there was a significant difference only between OF group and CO group in body weight and waist circumference (P > 0.001, P = 0.039, respectively). However, no significant group × time effects were found for the moderate to vigorous physical activity and sedentary behavior (P = 0.979, P = 0.578, respectively). CONCLUSION: Our online weight management program showed significant weight loss and waist circumference reduction in overweight or obese Korean women. Further research is needed to track the long term effects.

Impact of COVID 19 pandemic lockdown on weight of patients in outpatient setting

BackgroundMaintaining body weight is a delicate balance achieved by proper nutrition, optimal sleep, stress management and adequate exercise. The COVID-19 pandemic and the subsequent lockdown presented unique challenges including access to a proper diet and/or right physical activity and change in stress levels as well as changes in sleep duration and pattern. MethodsPatients in an outpatient practice were handed the survey questionnaire which they patients completed and handed back at check out. This was a one-time survey. Questions included information about weight before and after lockdown/stay at home order, food intake, physical activity, sleep and stress levels. Using IBM SPSS Statistics Software analysis of variance was calculated for each group with a determined alpha value of 0.05. This was used to determine statistical significance in weight change between the groups. ResultsA significant difference in weight change based on patients’ self-report of change in stress levels was found with p = 0.04. Of individuals who reported a decrease in stress had a mean weight loss of 3.58lbs, while individuals who reported an increase in stress reported a weight gain of 2.39lbs. ConclusionIn our study, we did find that the COVID restrictions have impacted all the above-mentioned lifestyle contributors, but we could only derive significant association between decreased stress and weight loss. Although we did see weight changes with change in all the above variables, it was not statistically significant.

Impact of short-chain fatty acid supplementation on gut inflammation and microbiota composition in a murine colitis model

Short-chain fatty acids (SCFAs) play a pivotal role in maintaining intestinal homeostasis. We aimed to investigate the effects of SCFA supplementation on gut inflammation and microbiota composition in a murine colitis model. Mice were fed with sodium butyrate or a mixture of SCFAs in the drinking water for 2 weeks, followed by 2% dextran sulfate sodium (DSS) for 7 d. After euthanasia, mouse colons were extracted to examine histological findings. Flow cytometry of the mouse colon tissues was performed to assess T cell differentiation. Changes in gut microbiota were assessed by high-throughput sequencing of the mouse feces. There were no significant differences in weight change, colonic length, or histologic inflammation score between the DSS, butyrate, and SCFA mix groups. However, flow cytometry revealed that both the expression of CD4+Foxp3+ regulatory T cells and of IL-17-producing T cells were increased in the butyrate and SCFA mix groups. Microbial compositions of the butyrate and SCFA mix groups were significantly different from those of the control and DSS groups in principal coordinate analysis. Relative abundances of the phyla Verrucomicrobia and Proteobacteria, species Akkermansia muciniphila and Escherichia fergusonii were increased in the butyrate and SCFA mix groups. Genera Roseburia and Lactobacillus showed a negative correlation with the degree of colitis, whereas genera Escherichia and Mucispirillum showed a positive correlation. SCFA supplementation did not result in a significant reduction in colon inflammation, but it promoted both regulatory T cell and IL-17-producing T cell expression, and increased both protective and aggressive gut microbiota.

The Long-Term Dietitian and Psychological Support of Obese Patients Who Have Reduced Their Weight Allows Them to Maintain the Effects.

The role of post-therapeutic support after weight loss in obesity treatment is not fully understood. Therefore, weight maintenance after a successful weight loss intervention is not very common, especially in obese individuals. This randomized controlled study was conducted to explore the efficacy of following dietary and psychological support in a group of 36 obese individuals. Participants (22 women, 14 men aged 35.58 ± 9.85 years, BMI 35.04 ± 3.80 kg/m2) who completed a 12-month weight loss phase (balanced energy-restricted diet) were randomly allocated to receive 18-month support (SG) or no additional care (CG). The support phase included some elements of Ten Top Tips (TTT), cognitive behavioral therapy (CBT), motivational interviewing (MI) in combination with nutritional education and assessment of the level of physical activity. The primary outcome was the maintenance of anthropometric parameters at an 18-month follow-up. The secondary outcomes included evaluation of biochemical parameters and single nucleotide polymorphisms (SNPs) in genes connected with obesity. A comparison of SG vs. CG after a 30-month period of the study revealed significant differences in weight changes (−3.83 ± 6.09 vs. 2.48 ± 6.24 kg), Body Mass Index (−1.27 ± 2.02 vs. 0.72 ± 2.12 kg/m2), visceral adipose tissue (−0.58 ± 0.63 vs. 0.45 ± 0.74 L), and waist circumference (−4.83 ± 4.05 vs. 1.83 ± 5.97 cm). Analysis of SNPs (rs9939609 FTO, rs987237 TFAP2B, and rs894160 PLIN1) provided further insight into the potential modulating effect of certain genotypes on weight loss and maintenance and extended the knowledge of the potential benefits of personalized medicine. Post-therapeutical support in current clinical practice may increase the chances of long-term weight loss maintenance in obesity treatment even in patients with a genetic predisposition to excessive weight.

In silico, in vitro, and in vivo investigation of antioxidant potential and toxicity of ethyl ferulate

By submitting this manuscript, each author certifies that they have made a direct and substantial contribution to the work reported in the manuscript. In this manuscript the conception, design, investigation, acquisition of data and analysis, interpretation of data and writing of the article were conducted by author Camila Bomfim de Sá under the guidance of professors Margareth de Fátima Formiga Melo Diniz, Hilzeth de Luna Freire Pessôa and Caliandra Maria Bezerra Luna Lima, who also approved the final version of the manuscript. Professor Damião Pergentino de Sousa and his student Mayara Castro de Morais performed the production, synthesis and chemical characterization of ethyl ferulate (EF). Professor Abrahão Alves de Oliveira Filho assessed the in silico tests. PhD student Andressa Brito Lira participated in the critical review of the text for important intellectual content and assisted in the in vitro antioxidant activity and cytotoxicity tests. Kardilandia Mendes de Oliveira participated in acute oral toxicity tests evaluating the biochemical parameters. Students, Tafaela Dias and Cinthia Rodrigues Melo also assisted in the acute oral toxicity testing and preparing of slides for histopathological analysis. Pathologist Alexandre Rolim da Paz analyzed the histopathology results. EF, a phenolic compound of the large class of phenylpropanoids, is derived from ferulic acid and is produced both naturally and synthetically. Its principal pharmacological activities are: anti-inflammatory and antioxidant activity. This study aimed to investigate the in silico, in vitro and in vivo toxicity and antioxidant activity of EF. The in silico prediction showed more than 20 biological activities as well as good absorption at the biological membranes and no theoretical toxicity. However, EF presented high environmental toxicity. EF presented low hemolytic potential and exerted protective activity for the erythrocyte membrane for only blood type O. EF presented antioxidant activity against H2O2 at all concentrations and all blood types, but no effect against phenylhydrazine, being unable to prevent its oxidative effects. In the acute nonclinical toxicological trial, the treated animals presented behavioral changes (e.g., sedation). Feed intake was higher for the 2000 mg/kg group, but with no significant difference in weight change. The biochemical parameters presented no differences between treated and control animals, and the organs remained intact with no change. Thus, EF presents a low toxic profile and this study provides important information about the toxicity of this compound, suggesting future safe use.

1005. Comparison of Weight Changes in Treatment-Naïve, HIV-Infected Patients Receiving Integrase Inhibitor-Based Therapy Versus Protease Inhibitor-Based Therapy

BackgroundRecent data regarding integrase inhibitor (INSTI) therapy indicate possible association with weight gain. The incidence and degree of weight gain seems to vary by both patient-specific and regimen-related factors, such as nucleoside reverse transcriptase (NRTI) backbone.MethodsThis was a retrospective chart review of previously ART-naïve Indiana University Health LifeCare Clinic patients who started an INSTI- or PI-based regimens from 1/1/13 to 7/31/19. Adult patients without prior ART exposure receiving an INSTI- or PI-based regimen for at least 10 months were included. The primary objective was weight gain at 12 months after starting ART. Subgroup analyses were conducted by INSTI, PI, or NRTI backbone utilized. Statistical testing included Wilcoxon Rank-Sum Test and Chi Square analyses.ResultsThe patient population (N=162) was predominately male and African American with relative immunocompetence, generally achieving viral suppression after 12 months of ART. Patients receiving PI-based therapy were more likely to be Asian American or Hispanic (p=0.04), and to receive a tenofovir disoproxil fumarate (TDF)-based regimen (p=0.0034). No statistically significant difference in weight change was observed between INSTI- and PI-based regimens (median weight gain 5.1 kg vs 3.9 kg, p=0.52). The proportion of obese or overweight patients in the INSTI arm increased significantly as compared to baseline (p=0.00001). Subgroup analyses demonstrated significant increases in weight gain and clinically significant weight gain with tenofovir-based (tenofovir alafenamide and TDF) regimens compared to those with abacavir/lamivudine (p< 0.05).Primary Objective BMI Category Changes by INSTI or PI Agent NRTI Subgroup Analyses ConclusionLack of power makes meaningful interpretation of the results for the primary objective difficult. However, several of the prespecified secondary objectives and subgroup analyses demonstrated clinically significant results related to increased weight gain or BMI category changes with INSTI-, PI-, and tenofovir-based regimens. Checking the patient’s weight at every appointment is considered standard practice at IU Health clinics, but missing values despite qualifying encounters were observed. Further commitment to standardized weighing practices should be a priority at clinics caring for patients living with HIV.Disclosures All Authors: No reported disclosures