Intensive Dietary Intervention Research Articles

Effect of DASH vs. Mediterranean diet on metabolic syndrome and cardiometabolic profile in adults with high normal blood pressure or grade 1 hypertension: the DASH-MedDiet randomized controlled trial

Abstract Background Lifestyle interventions are recommended as the first-line treatment to control metabolic syndrome components and improve cardiometabolic profile. However, studies directly comparing the effects of the Dietary Approaches to Stop Hypertension (DASH) vs. the Mediterranean diet (MedDiet) on metabolic syndrome prevalence and cardiometabolic risk factors are currently lacking. Purpose We aimed to assess the effects of a 3-month intensive dietary intervention implementing salt restriction either alone or on top of the DASH and MedDiet compared to no/ minimal intervention on metabolic syndrome prevalence and cardiometabolic profile in never drug-treated adults with high normal blood pressure (BP) or grade 1 hypertension. Methods We randomly assigned individuals to the control group (CG, n = 60), salt restriction group (SRG, n = 60), DASH diet with salt restriction group (DDG, n = 60), or MedDiet with salt restriction group (MDG, n = 60). All patients were followed monthly for 3 months in individual sessions coordinated by the clinical dietician. For the patients of all four study groups, the goal was to maintain the initial body weight unchanged. Patients in the CG received general advice on dietary principles for BP control. For the patients in all three intervention groups, the goal was to limit sodium intake to 2,000 mg/ day (equivalent to 5,0g salt/ day). In addition, patients in the DDG and the MDG received an individualized dietary plan with six daily sample menus to facilitate the adoption of the assigned dietary pattern. Anthropometric indices, dietary intake, office BP, and fasting blood samples were evaluated pre- and post-intervention. Results According to the intention-to-treat analysis, at 3 months post-intervention, the DDG and the MDG had lower odds ratio (OR) (95% CI) of metabolic syndrome [0.29 (0.12, 0.72), and 0.15 (0.06, 0.41), respectively] compared to the CG. Moreover, the MDG had lower odds of elevated BP levels compared to both the DDG and the SRG [0.08 (0.03, 0.19), and 0.13 (0.05, 0.34), respectively], and lower odds of metabolic syndrome compared to the SRG [0.25 (0.09, 0.67)]. In addition, the DDG and the MDG had lower odds of elevated fasting glucose compared to both the CG and the SRG, whereas the study groups did not differ regarding the odds of elevated waist circumference, elevated triglycerides, and reduced HDL- cholesterol. Regarding cardiometabolic indices, total and LDL-cholesterol, fasting glucose, HbA1c, and systolic/ diastolic BP were reduced in all three intervention groups compared to the CG. Conclusions On a background of salt restriction, the MedDiet was superior in BP reduction, but the DASH and MedDiet reduced the prevalence of metabolic syndrome to the same extent.

Family meals on prescription as treatment for childhood obesity-a randomized controlled trial.

The aim with the present study was to evaluate the effects and tolerability of Family Meals on Prescription, a 3-month intensive dietary intervention with a participatory approach on body mass index (BMI) and metabolic health in children living with obesity. In this prospective randomized controlled trial, children aged 5-15years were included from the Pediatric Obesity outpatient Clinics in Halland, Sweden. Participants were randomly assigned to receive lifestyle treatment with or without Family Meals on Prescription (FMP) consisting of a subsidized prepacked grocery bag including recipes and provisions for five Family Meals per week for 3months. The primary endpoint was changed in BMIz after 3, 12 and 18-24months and secondary endpoints included to assess tolerability of FMP and effects on metabolic biomarker and frequency of shared meals. Eighty-nine children (51.7% female) entered the study, 54 patients in the intervention group and 35 in the control group. There were no significant differences between the groups concerning gender, age or level of obesity at baseline. The Family Meal on Prescription intervention combined with lifestyle treatment led to a significantly greater reduction in BMIz than lifestyle treatment alone after the 3-month long intervention (- 0.17 vs + 0.01, p < 0.01); however, this difference was not sustained throughout the study period, and in fact, the control group had a greater reduction in BMIz after 18-24months.A subsidized prepacked grocery bag may be a novel, well-tolerated and effective tool in the treatment of childhood obesity. The fact that the BMIz reduction shown at the end of the intervention did not persist over time emphasized the need of long-term treatment. Registered at clinicaltrals.gov 27 Nov 2020, retrospectively registered: clinicaltrials.gov number 19002468. https://clinicaltrials.gov/study/NCT05225350 What is Known: • Swedish data shows that lifestyle treatment alone is not sufficient for many families undergoing treatment for childhood obesity. • Regular family meals and mealtime routines have been shown to be important for nutritional health and dietary patterns in children and adolescents. What is New: • This intervention with a participatory approach involving prepacked family meals was well tolerated and led to a significant reduction in BMIz during the intervention. • That fact that these results were not sustained over time indicates a need to evaluate longer interventions, and that childhood obesity is a chronic and complex disease which requires long-time treatments.

Effect of DASH vs. mediterranean diet accompanied by a salt restriction on metabolic syndrome and cardiometabolic risk factors in adults with high normal blood pressure or grade 1 hypertension: secondary analyses of a randomized controlled trial

ObjectiveLifestyle interventions are recommended as the first-line treatment to control metabolic syndrome components and improve cardiometabolic risk factors. However, studies directly comparing the cardiometabolic effects of the Dietary Approaches to Stop Hypertension (DASH) vs. the Mediterranean diet (MedDiet) accompanied by salt restriction are currently lacking. Thus, with the present secondary analyses of a randomized trial, we aimed to assess the cardiometabolic effects of a 3-month intensive dietary intervention implementing salt restriction alone or on top of the DASH and MedDiet compared to no/minimal intervention in never drug-treated adults with high normal blood pressure (BP) or grade 1 hypertension. MethodsWe randomly assigned individuals to the control group (CG, n = 60), salt restriction group (SRG, n = 60), DASH diet with salt restriction group (DDG, n = 60), or MedDiet with salt restriction group (MDG, n = 60). ResultsAccording to the intention-to-treat analysis, the DDG and the MDG had lower odds ratio (OR) (95% CI) of metabolic syndrome [0.29 (0.12, 0.72), and 0.15 (0.06, 0.41), respectively] compared to the CG. Moreover, the MDG had lower odds of metabolic syndrome compared to the SRG and lower odds of elevated BP levels than the DDG and the SRG. Moreover, total and LDL-cholesterol, fasting glucose, HbA1c, and systolic/diastolic BP were reduced in all three intervention groups compared to the CG. ConclusionOn a background of salt restriction, the MedDiet was superior in BP reduction, but the DASH and MedDiet reduced the prevalence of metabolic syndrome to the same extent.

Effect of a personalized intensive dietary intervention on base excision repair (BER) in colorectal cancer patients: Results from a randomized controlled trial

DNA repair is essential to maintain genomic integrity and may affect colorectal cancer (CRC) patients’ risk of secondary cancers, treatment efficiency, and susceptibility to various comorbidities. Bioactive compounds identified in plant foods have the potential to modulate DNA repair mechanisms, but there is limited evidence of how dietary factors may affect DNA repair activity in CRC patients in remission after surgery. The aim of this study was to investigate the effect of a 6-month personalized intensive dietary intervention on DNA repair activity in post-surgery CRC patients (stage I-III). The present study included patients from the randomized controlled trial CRC-NORDIET, enrolled 2–9 months after surgery. The intervention group received an intensive dietary intervention emphasizing a prudent diet with specific plant-based foods suggested to dampen inflammation and oxidative stress, while the control group received only standard care advice. The comet-based in vitro repair assay was applied to assess DNA repair activity, specifically base excision repair (BER), in peripheral blood mononuclear cells (PBMCs). Statistical analyses were conducted using gamma generalized linear mixed models (Gamma GLMM). A total of 138 CRC patients were included, 72 from the intervention group and 66 from the control group. The BER activity in the intervention group did not change significantly compared to the control group. Our findings revealed a substantial range in both inter- and intra-individual levels of BER. In conclusion, the results do not support an effect of dietary intervention on BER activity in post-surgery CRC patients during a 6-month intervention period.

Abstract P492: Polygenic Risk for Obesity and Race Modify the Effect of a Low Fat Dietary Clinical Trial on Weight Loss

Introduction: Research populations harbor innate and acquired characteristics that can introduce substantial treatment response heterogeneity. Weight loss interventions show this variability, likely due to behavioral and physiological characteristics. Genetic risk for obesity is a potential but largely unexplored factor in weight loss trials. We examined whether genetic risk for obesity modified the effect of a low-fat diet on weight change in a randomized controlled trial. Methods: A data from the Women’s Health Initiative Dietary Modification Trial, including 10,353 postmenopausal women aged 50-79 with genotype data [63% European American (EAs), 37% African American (AAs)] were randomized into control and low-fat diet groups. The outcome was visit-specific weight difference (kg) from baseline. The Polygenic Risk Score of body mass index (PRS BMI ) was computed using the PRS-CS method and an independent trans-ancestry genome-wide association study of BMI (N = ~ 2M; 79 % EAs and 4 % AAs). We operationalized PRS BMI as a binary variable, distinguishing individuals in the 95 th percentile from the remaining individuals. Association was tested using generalized estimated equations with a 3-way interaction term (PRS х randomization х time), adjusting for 10 principal components, age, baseline BMI, and follow-up status. Analyses were performed separately by race/ethnicity, because body weight is influenced by ancestral diversity, which affects both linkage disequilibrium, PRS effect sizes, and cultural factors (e.g., racism). Results: Baseline, we had 6,473 EAs (mean age: 65.4 ± 6.6 years, mean BMI: 29.5 ± 6.5 kg/m 2 ) and 3,880 AAs (mean age: 60.9 ± 6.7years, mean BMI: 32.1 ± 6.8 kg/m 2 ) and mean follow-up was 6.0 ± 1.8 years. PRS BMI explained 12% of the variance in the baseline BMI measure in EAs and 8% in AAs. During the first year of intensive dietary intervention (18 sessions/yr), the low-fat diet group experienced 2.1 kg and 1.1 kg weight loss in European and AAs respectively, with no differences in PRS BMI . During years 1-7 with reduced intervention intensity (4 sessions/yr), the rate of weight change in both race/ethnic groups were modified by PRS BMI , although in different directions. EAs with high PRS (95 th percentile) in the intervention group rebounded towards initial weight (0.35 kg/year, p&lt;0.001) nearly twice as fast as those women with PRS &lt; 95 th percentile (0.19 kg/year, p&lt;0.001). Conversely, high PRS African American women in the intervention group maintained their weight loss without rebound (-0.10 kg/year, p=0.48), distinctly different from those with PRS &lt; 95 th percentile, who gained 0.25 kg annually (p&lt;0.001). Conclusions: Impact of long-term low-fat dietary intervention on weight change was modified by genetic risk and race/ethnicity. Genetic predisposition and other contextual factors may be considered in the design and analysis of relevant clinical trials.

Weight Loss for Patients With Gout and Concomitant Obesity: A Proof-of-Concept Randomized Trial.

Despite scarce evidence, guidelines recommend weight loss as a management strategy for patients with gout. We investigated the effect of an intensive dietary intervention on body weight and clinical measures of gout severity in individuals with obesity and gout. We conducted a 16-week randomized nonmasked parallel-group trial in Denmark, randomly assigning (one-to-one) individuals with obesity and gout to a low-energy diet or a control diet. The primary outcome was change in body weight. Key secondary outcomes were changes in serum urate (SU) level and visual analog scale-assessed pain and fatigue. Between December 1, 2018, and June 1, 2019, 61 participants were included in the intention-to-treat population and randomly assigned to the intensive diet group (n=29) or control diet group (n=32). Participants had a mean age of 60.3 (SD 9.9) years and mean body mass index of 35.6 (SD 5.0), and 59 (97%) were men. After 16 weeks, there was a significant difference in change in body weight between the diet and control groups (-15.4 vs -7.7 kg; difference -7.7 kg [95% confidence interval -10.7 to -4.7], P < 0.001). Despite results being potentially in favor of a low-energy diet, we could not confirm differences in SU level changes and fatigue between groups. No differences in pain and gout flares were observed between groups. No serious adverse events or deaths occurred during the trial. An intensive dietary intervention was safe and effectively lowered body weight in people with obesity and gout, but the weight loss did not directly translate into effects on SU level, fatigue, and pain.

DASH vs. Mediterranean diet on a salt restriction background in adults with high normal blood pressure or grade 1 hypertension: A randomized controlled trial

Non-pharmacological measures are recommended as the first-line treatment for individuals with high-normal blood pressure (BP) or mild hypertension. Studies directly comparing the BP effects of the Dietary Approaches to Stop Hypertension (DASH) vs. the Mediterranean diet (MedDiet) on a salt restriction background are currently lacking. Thus, our purpose was to assess the BP effects of a 3-month intensive dietary intervention implementing salt restriction either alone or in the context of the DASH, and the MedDiet compared to no/minimal intervention in adults with high normal BP or grade 1 hypertension. We randomly assigned never drug-treated individuals to a control group (CG, n=60), a salt restriction group (SRG, n=60), a DASH diet with salt restriction group (DDG, n=60), or a MedDiet with salt restriction group (MDG, n=60). The primary outcome was the attained office systolic BP difference among the randomized arms during follow-up. A total of 240 patients were enrolled, while 204 (85%) completed the study. According to the intention-to-treat analysis, compared to the CG, office and 24h ambulatory systolic and diastolic BP were reduced in all intervention groups. A greater reduction in the mean office systolic BP was observed in the MDG compared to all other study groups (MDG vs. CG: mean difference=-15.1mmHg; MDG vs. SRG: mean difference=-7.5mmHg, and MDG vs. DDG: mean difference=-3.2mmHg, all P-values <0.001). The DDG and the MDG did not differ concerning the office diastolic BP and the 24h ambulatory systolic and diastolic BP; however, both diets were more efficient in BP-lowering compared to the SRG. On a background of salt restriction, the MedDiet was superior in office systolic BP-lowering, but the DASH and MedDiet reduced BP to an extent higher than salt restriction alone.

Effect of a one-year personalized intensive dietary intervention on body composition in colorectal cancer patients: Results from a randomized controlled trial

Changes in body composition may affect colorectal cancer (CRC) patient's risk of cancer recurrence, secondary cancer, and other chronic diseases. The suggested interventions for changes in body composition such as low muscle mass or high fat mass, are diet and physical activity. Nevertheless, there is limited evidence of how dietary intervention alone can impact body composition. This study aimed to investigate the effect of a 6 and 12 month dietary intervention with a focus on healthy eating according to Norwegian food-based dietary guidelines on weight and body composition in patients with CRC stage I-III, post-surgery. This study included participants from the randomized controlled trial CRC-NORDIET study 2-9 months after surgery. The intervention group received an intensive dietary intervention, while the control group underwent similar measurements, but no dietary intervention. Body composition was measured with Lunar iDXA, and the results were analyzed using linear mixed models. A total of 383 participants were included, 192 in the intervention group and 191 in the control group. After 6 months, the intervention group showed a 0.7kg lower mean weight gain (p=0.020) and 0.6kg lower fat mass gain (p=0.019) than the control group, but no difference at 12 months. Moreover, the fat mass increase was 0.5 percentage points lower at 6 months (p=0.012), and 0.7 percentage points lower at 12 months (p=0.011) in the intervention group compared to the controls. At 6 months, the intervention group had 63g lower gain of visceral adipose tissue compared to the control group (p=0.031). No differences were seen for fat-free mass or subcutaneous adipose tissue at any time point. The intervention group showed a lower increase in the ratio between fat mass and fat-free mass at both 6 months (p=0.025) and 12 months (p=0.021). The dietary intervention reduced the increases in total weight and fat masses, without changing fat-free mass. Although the individual changes are small, the dietary intervention may have resulted in an overall more favourable body composition profile. These findings suggest that dietary intervention may be part of a treatment strategy for prevention of weight and fat mass gain in CRC survivors.

DASH VS. MEDITERRANEAN DIET ON A SALT RESTRICTION BACKGROUND IN ADULTS WITH HIGH NORMAL BLOOD PRESSURE OR GRADE 1 HYPERTENSION: A RANDOMIZED CONTROLLED TRIAL

Objective: Non-pharmacological measures are recommended as the first-line treatment for individuals with high-normal blood pressure (BP) or mild hypertension. Studies directly comparing the BP effects of the Dietary Approaches to Stop Hypertension (DASH) vs. the Mediterranean diet (MedDiet) on a salt restriction background are currently lacking. Thus, our purpose was to assess the BP effects of a 3-month intensive dietary intervention implementing salt restriction either alone or in the context of the DASH, and the MedDiet compared to no/ minimal intervention in adults with high normal BP or grade 1 hypertension. Design and method: We randomly assigned never drug-treated individuals to a control group (CG, n = 60), a salt restriction group (SRG, n = 60), a DASH diet with salt restriction group (DDG, n = 60), or a MedDiet with salt restriction group (MDG, n = 60). The primary outcome was the attained office systolic BP difference among the randomized arms at the end of the study. Results: A total of 240 patients were enrolled, while 204 (85%) completed the study. According to the intention-to-treat analysis, compared to the CG, office and 24h ambulatory systolic and diastolic BP were reduced in all intervention groups. A greater reduction in the mean office systolic BP was observed in the MDG compared to all other study groups (MDG vs. CG: mean difference = -15.1 mm Hg; MDG vs. SRG: mean difference = -7.5 mm Hg, and MDG vs. DDG: mean difference = -3.2 mm Hg, all P-values &lt; 0.001). The DDG and the MDG did not differ concerning the office diastolic BP and the 24h ambulatory systolic and diastolic BP; however, both diets were more efficient in BP-lowering compared to the SRG. Conclusions: On a background of salt restriction, the MedDiet was superior in office systolic BP-lowering, but the DASH and MedDiet reduced BP to an extent higher than salt restriction alone. Registration number: NCT05669404

Application of the Updated WCRF/AICR Cancer Prevention Score as an Outcome for Cancer Survivors Participating in a Tailored and Intensive Dietary and Physical Activity Intervention.

The World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) has defined evidence-based guidelines for cancer prevention. These recommendations have been operationalized into a quantitative index for individual assessment. Survivors of cancer are increasingly desiring guidance for diet and lifestyle, and in the absence of research in survivors, are often instructed to follow cancer prevention and public health guidelines. In this study, we examine the utility of the quantitative updated WCRF/AICR scoring criteria to assess change among cancer survivors with overweight/obesity (OW/OB) following an intensive behavioral intervention. We applied the WCRF/AICR scoring criteria (range 0-7) to examine changes over the duration of the study by paired t-tests. Two cancer survivor cohorts with OW/OB (n = 91) completed a six-month phase II clinical trial designed to improve dietary and physical activity patterns. At enrollment and post-intervention, participants completed assessments including anthropometrics, food frequency questionnaires, and objective evaluation of physical activity. Participants improved adherence to all scored recommendations, with a significant increase in mean score from enrollment (3.22 ± 1.06) to post-intervention (4.28 ± 1.04) (p &lt; 0.001). Mean BMI and waist circumference improved (both p &lt; 0.001). The greatest improvements were noted for fruit and non-starchy vegetable intakes (+39%, p &lt; 0.001); the greatest decreases were observed for processed meat consumption (-70%, p &lt; 0.001). The updated WCRF/AICR Score can be applied to cancer survivor intervention studies and provides a tool to compare trials in regard to the baseline status of populations enrolled and the success of the intervention. Future interventions incorporating standardized assessments will help guide effective strategies to improve the health and quality of life for cancer survivors.

Dietitian‐supported dietary intervention leads to favorable dietary changes in patients with type 2 diabetes: A randomized controlled trial

It remains to be fully elucidated whether nutrition education by dietitians can lead to specific positive changes in the food choices of patients with diabetes. A total of 96 patients with type 2 diabetes and diabetic kidney disease were randomly assigned to the intensive intervention group that received nutritional education at every outpatient visit and the control group that received nutritional education once a year. The total energy intake, energy-providing nutrients and 18 food groups were analyzed at baseline, and 1 and 2 years after the intervention in 87 patients. Furthermore, the relationship between the changes in hemoglobin A1c, body composition and changes in the total energy or energy-producing nutrient intake was analyzed in 48 patients who did not use or change hypoglycemic agents during the study period. The total energy intake, carbohydrates, cereals, confections, nuts and seeds, and seasonings significantly decreased, and fish and shellfish intake significantly increased during the study period in the intensive intervention group, whereas these changes were not observed in the control group. The decrease in the total energy intake and carbohydrates after 2 years was significantly greater in the intensive intervention group than in the control group. The change in the total energy and carbohydrate intake showed a significant positive correlation with that in muscle mass. The multivariate analysis showed that the decrease in total energy intake was independently associated with that in muscle mass. Dietitian-supported intensive dietary intervention helps improve the diet of patients with type 2 diabetes.

Knee joint osteoarthritis in obese subjects, effects of diet and exercise on knee joint loading: a review of literature

The incidence of osteoarthritis (OA) is greater in the knee than in other joints and is increasing. This could be because of an increase in the applied loads on this joint or because of a change in the alignment of the knee joint. The aim of this review was to determine the effects of being overweight on knee joint OA. Moreover, it aimed to determine whether a change in body weight by diet or exercise influenced the loads applied on the knee joint and decreased the incidence of knee OA. A systematic literature search was carried out to find the literature published on the effects of joint loading and being overweight on knee OA in databases such as Medline, PubMed, Embase, Web of Sciences, Scopus, and Google Scholar. The key words such as knee OA and loading, knee OA and joint contact forces, knee OA and body weight were used to determine the effects of joint loading on knee OA. The quality of the studies was evaluated by use of Downs and Black tool. There were 15 studies on the effects of joint loading, overweight, and obesity on joint contact force and knee OA symptoms and three studies on the effects of weight loss, exercise, and intensive diet intervention on joint loading. The quality of these papers varied between 9 and 20. The results of this review showed that obese subjects are at high risk of knee OA because of change in alignment of the knee joint and also overloading of the joint. Use of approaches such as diet and exercise may decrease the loads applied on the joint and decrease the incidence of knee OA.

Usefulness of MCP-1 Chemokine in the Monitoring of Patients with Coronary Artery Disease Subjected to Intensive Dietary Intervention: A Pilot Study.

Monocyte chemotactic protein-1 (MCP-1) plays an important role in the entire atherosclerotic process, from atherogenesis to destabilisation of the atherosclerotic plaque. The purpose of this study is to evaluate the effect of the dietary approaches to stop hypertension (DASH) diet in patients with coronary artery disease on the MCP-1 plasma concentration and to evaluate the potential usefulness of this chemokine as a marker of change in the volume and composition of coronary plaque. Material and method. As part of the dietary intervention to stop coronary atherosclerosis in computed tomography (DISCO-CT) study, patients were randomised to an intervention group (n = 40) in which the DASH diet was introduced, and to a control group (n = 39) with no dietary intervention. In the DASH group, dietary counselling was provided at all follow-up visits within 12 months of the follow-up period. MCP-1 plasma concentration was determined using enzyme-linked immunosorbent assay (ELISA). Coronary plaque analysis was performed using a semi-automated plaque analysis software system (QAngioCT, Medis, The Netherlands). Results. In the DASH group, MCP-1 plasma concentration significantly decreased by 34.1 pg/mL (p = 0.01), while in the control group, the change in MPC-1 was not significant. Significant inverse correlations were revealed for the change in MCP-1 plasma concentration and change in the consumption of vitamin C and dietary fibre both in the DASH (r = −0.519, p = 0.0005; r = −0.353, p = 0.025, respectively) and in the control group (r = −0.488 p = 0.001; r = −0.502, p = 0.001, respectively). In patients with the highest decrease in percent atheroma volume (PAV), a significant positive correlation was observed between the change in MCP-1 plasma concentration and changes in PAV (r = 0.428, p = 0.033) and calcified plaque component (r = 0.468, p = 0.018), while the change in noncalcified plaque component correlated inversely with change in MCP1 (r = −0.459, p = 0.021). Conclusion. Dietary intervention based on the DASH diet model reduces the MCP-1plasma concentration, mostly due to an increased intake of plant-derived, fibre-rich foods and antioxidants. The change in MCP-1 plasma concentration seems to reflect changes in the atheroma volume and proportions between the calcified and non-calcified plaque elements.

Effect of Advanced Glycation End Products on Cognition in Older Adults with Type 2 Diabetes: Results from a Pilot Clinical Trial

Background: Dietary advanced glycation end-products (AGEs) are linked to cognitive decline. However, clinical trials have not tested the effect of AGEs on cognition in older adults. Objective: The aim of the current pilot trial was to examine the feasibility of an intervention to reduce dietary AGEs on cognition and on cerebral blood flow (CBF). Methods: The design is a pilot randomized controlled trial of dietary AGEs reduction in older adults with type 2 diabetes. Seventy-five participants were randomized to two arms. The control arm received standard of care (SOC) guidelines for good glycemic control; the intervention arm, in addition to SOC guidelines, were instructed to reduce their dietary AGEs intake. Global cognition and CBF were assessed at baseline and after 6 months of intervention. Results: At baseline, we found a reverse association between AGEs and cognitive functioning, possibly reflecting the long-term toxicity of AGEs on the brain. There was a significant improvement in global cognition at 6 months in both the intervention and SOC groups which was more prominent in participants with mild cognitive impairment. We also found that at baseline, higher AGEs were associated with increased CBF in the left inferior parietal cortex; however, 6 months of the AGEs lowering intervention did not affect CBF levels, despite lowering AGEs exposure in blood. Conclusion: The current pilot trial focused on the feasibility and methodology of intervening through diet to reduce AGEs in older adults with type 2 diabetes. Our results suggest that participants with mild cognitive impairment may benefit from an intensive dietary intervention.

Adjunctive dietary intervention for bipolar disorder: a randomized, controlled, parallel-group, modified double-blinded trial of a high n-3 plus low n-6 diet.

To investigate the preliminary efficacy of a high n-3 plus low n-6 (H3-L6) dietary intervention in improving mood stability in Bipolar Disorder (BD) when compared to dietary intervention with usual U.S. levels of n-6 and n-3 polyunsaturated fatty acid (PUFA) intakes (control diet, CD). This 2-arm, parallel-group, randomized, modified double-blind, controlled 48-week study of 12-week intensive diet intervention in subjects with BD was conducted at a single suburban-rural site in the mid-Atlantic region. Participants with DSM-IV TR BD I or II with hypomanic or depressive symptoms were randomized, stratified on gender (N=82). The intervention included the provision of group-specific study foods and dietary counseling. Variability of mood symptoms was measured by a twice-daily, 12-week ecological momentary analysis (EMA) paradigm, and group differences were analyzed using multilevel models. Circulating n-3 and n-6 fatty acids were measured at baseline and after 4, 8, and 12weeks of diet exposure. All 82 randomized participants were included in biochemical analyses. Seventy participants completed at least 2 EMA surveys and were included in primary EMA analyses. Variability in mood, energy, irritability, and pain as measured using EMA was reduced in the H3-L6group compared to the CD group. No significant differences in mean ratings of mood symptoms, or any other symptom measures, were detected. The dietary intervention effect on target PUFAs significantly differed by the group over time. A dietary intervention adjunctive to usual care showed preliminary efficacy in improving variability in mood symptoms in participants with BD. ClinicalTrials.Gov NCT02272010.

Methodology for altering omega-3 EPA+DHA and omega-6 linoleic acid as controlled variables in a dietary trial

Increasing dietary intake of n-3 EPA+DHA and lowering dietary n-6 LA is under investigation as a therapeutic diet for improving chronic pain syndromes as well as other health outcomes. Herein we describe the diet methodology used to modulate intake of n-3 and n-6 PUFA in a free living migraine headache population and report on nutrient intake, BMI and diet acceptability achieved at week 16 of the intensive diet intervention and week 22 follow-up time-point. A total of 178 participants were randomized and began one of three diet interventions: 1) a high n-3 PUFA, average n-6 PUFA (H3) diet targeting 1500mg EPA+DHA/day and 7% of energy (en%) from n-6 linoleic acid (LA), 2) a high-n-3 PUFA, low-n-6 PUFA (H3L6) targeting 1500mg EPA+DHA/day and <1.8 en% n-6 LA or 3) a Control diet with typical American intakes of both EPA+DHA (<150mg/day) and 7 en% from n-6 LA. Methods used to achieve diet change to week 16 include diet education, diet counseling, supply of specially prepared foods, self-monitoring and access to online diet materials. Only study oils and website materials were provided for the follow-up week 16 to week 22 periods. Diet adherence was assessed by multiple 24h recalls administered throughout the trial. Diet acceptability was assessed in a subset of participants at 4 time points by questionnaire. At week 16 H3 and H3L6 diet groups significantly increased median n-3 EPA+DHA intake from 48mg/2000kcals at baseline to 1484mg/2000kcals (p<0.0001) and from 44mg/2000kcals to 1341mg/2000kcals (p<0.0001), respectively. In the Control group, EPA+DHA intake remained below the typical American intake with baseline median at 60mg/2000kcals and 80mg/2000kcals (p=0.6) at week 16. As desired, LA intake was maintained in the H3 and Control group with baseline median of 6.5 en% to 7.1 en% (p=0.4) at week 16 and from 6.5 en% to 6.8 en% (p=1.0) at week 16, respectively. In the H3L6 group, n-6 LA decreased from 6.3 en% at baseline to 3.2 en% (p<0.0001) at week 16. There were no significant changes in BMI or diet acceptability throughout the trial or between diet groups. We find this diet method to be acceptable to research participants and successful in altering dietary n-3 EPA+DHA with and without concurrent decreases in n-6 LA. If n-6 LA of less than 3 en% is desired, additional techniques to limit LA may need to be employed.

Changes in physical activity during a one-year weight loss trial with liraglutide in participants with knee osteoarthritis: secondary analyses of a randomised trial

Changes in physical activity during a one-year weight loss trial with liraglutide in participants with knee osteoarthritis: secondary analyses of a randomised trial

The Effect of Intensive Dietary Intervention on the Level of RANTES and CXCL4 Chemokines in Patients with Non-Obstructive Coronary Artery Disease: A Randomised Study.

Simple SummaryThe dietary approaches to stop hypertension (DASH) diet contains meals with plenty of vegetables, fruits and low-fat dairy products, as well as whole grains, fish, poultry and nuts. One of the potential mechanisms of the beneficial effects of the DASH diet on the cardiovascular system may be modification of the inflammatory process. In the present study, we assessed the impact of the DASH diet on selected inflammatory markers in patients with atherosclerosis. The study lasted 12 months and involved 79 patients (40 followed the DASH diet, while 39 were in the control group). The results indicate that the DASH diet lowers the level of the inflammatory markers, which may contribute to the inhibition of atherosclerosis.Background: Inflammation is the key pathophysiological mechanism of the initiation and progression of atherosclerosis. The study objective was to assess the effects of a dietary intervention based on the model of the dietary approaches to stop hypertension (DASH) diet on the levels of chemokines RANTES and CXCL4 in patients with non-obstructive coronary artery disease. Methods: As part of Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography (DISCO-CT) study, patients were randomised to an intervention group (n = 40), where the DASH diet was introduced along with optimal pharmacotherapy, and to a control group (n = 39), with optimal pharmacotherapy alone. In the DASH group, systematic dietary counselling was provided for the follow-up period. RANTES and CXCL4 levels were determined using ELISA. Results: In the DASH group, the RANTES level insignificantly reduced from 42.70 ± 21.1 ng/mL to 38.09 ± 18.5 ng/mL (p = 0.134), and the CXCL4 concentration significantly reduced from 12.38 ± 4.1 ng/mL to 8.36 ± 2.3 ng/mL (p = 0.0001). At the same time, an increase in the level of both chemokines was observed in the control group: RANTES from 34.69 ± 22.7 to 40.94 ± 20.0 ng/mL (p = 0.06) and CXCL4 from 10.98 ± 3.6 to 13.0 5± 4.8 ng/mL (p = 0.009). The difference between the changes in both groups was significant for both RANTES (p = 0.03) and CXCL4 (p = 0.00001). The RANTES/CXCL4 ratio reduced in the control group (from 3.52 ± 2.8 to 3.35 ± 2.8; p = 0.006), while in the DASH group, an increase was observed (from 3.54 ± 1.7 to 4.77 ± 2.4; p = 0.001). Conclusions: A 12-month-long intensive dietary intervention based on DASH diet guidelines as an addition to optimal pharmacotherapy causes changes in the levels of chemokines CXCL4 and RANTES and their mutual relationship in comparison to conventional treatment.

High-risk plaque regression after intensive dietary intervention in patients with non-obstructive coronary artery disease: a randomised computed tomography angiography study (DISCO-CT)

Abstract Background Lifestyle and diet modification are the forefront in the management of coronary artery disease (CAD), however, there is no data whether they may stop progression of atheroslcerosis. Some coronary plaque characteristics are known to increase the risk of future cardiovascular events independently of coronary stenosis severity. These plaques are characterized by the presence of lipids and necrotic elements, and can be identified with coronary computed tomography angiography (CTA). Purpose To study the effect of intensive dietary intervention on changes in atherosclerotic plaque volume and composition. Methods We enrolled 89 patients (41% women, mean age 60±7.7 years) with nonobstructive coronary lesions (&amp;lt;70% stenosis) identified by CTA (2x192-multislice scanner, temporal resolution 66 ms), qualified to medical treatment. All participants were subjected to optimal medical therapy (OMT). Patients were randomised (1:1) to either A) OMT with regular follow-up (after 1, 3, 6, 9 and 12 months) by a dietitian to stick to Dietary Approaches to Stop Hypertension (DASH) model, or B) routine management, ie. OMT alone. CTA was repeated in all patients after the mean time of 66.9±13.7 weeks. An experienced observer blinded to the allocated treatment group and other clinical data evaluated all of the scans. The outcome was change in total plaque volume, percent plaque volume and plaque composition, assessed with a dedicated software system. Based on tissue attenuation ranges in Hounsfield units (HU), the following components of atheroma were distinguished: dense calcium (&amp;gt;351 HU), fibrous plaque (151 to 350 HU), and fibrofatty plaque plus necrotic core (−100 to 150 HU), regarded as the vulnerable plaque component. Results Total plaque volume did not change significantly in any group (p=0.41; Figure 1A). Percent atheroma volume increased in the control arm vs. no significant change in the experimental arm, with no significant intergroup difference (p=0.79; Figure 1B). Vulnerable plaque component decreased in both subgroups, by 52.9±82.2 mm3 in the experimental vs. 20.8±58.5 mm3 in the control arm, and there was a significant difference in the reductions between the groups (p=0.04; Figure 1C). Fibrous plaque volume and dense calcium volume did not change significantly in any group (+9.5±117.8 mm3 in the experimental vs. +7.6±92.1 mm3 in the control arm, p=0.93, and +33±68.9 mm3 vs. +30.2±52.5 mm3, p=0.78, respectively). Conclusions Intensive diet intervention atop OMT can stop the progression of atherosclerosis and lead to a significant reduction in vulnerable plaque component compared to OMT alone. Figure 1 Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Institute of Cardiology in Warsaw, Poland

OP0172 EFFECT OF WEIGHT LOSS AND LIRAGLUTIDE ON SERUM URATE LEVELS AMONG OBESE KNEE OSTEOARTHRITIS PATIENTS: SECONDARY ANALYSIS OF A RANDOMISED CONTROLLED TRIAL

Background:There is a strong association between gout and obesity. Lowering urate is the cornerstone of gout management [1] and urate levels correlate strongly with central obesity. Previous studies suggest that weight loss has a positive effect on serum urate, however, the studies are sparse and small [2].Objectives:To assess the impact of an initial low-calorie diet-induced weight loss and subsequent randomisation to the body weight-lowering drug liraglutide (a glucagon-like peptide 1 receptor agonist) or placebo on serum urate levels.Methods:In the LOSE-IT trial (NCT02905864), a randomised, double-blinded, placebo-controlled, parallel group, single-centre trial [3], 156 obese individuals with knee osteoarthritis, but without gout, were offered an initial 8-week intensive diet intervention (week -8 to 0) on Cambridge Weight Plan (800-1000 kcal/day) followed by a weight loss maintenance period in which participants were randomised to either liraglutide 3 mg/day or placebo for 52 weeks. We conducted a secondary analysis of blood samples collected at week -8, 0 and 52. The primary outcome measure was change in serum urate. We used paired t-test for the change from week -8 to 0, and for change from week 0 to 52 we used an ANCOVA model adjusted for stratification factors (sex, age category and obesity class), and the level of the outcome at baseline. Data were analysed as observed (i.e. no imputation of missing data).Results:156 individuals were randomised and 155 had blood samples taken at baseline. In the initial intensive diet intervention period (week -8 to 0) they lost a mean of 12.5 kg (95% CI -13.1 to -11.9, n 156). In the following 52 weeks, the liraglutide group lost an additional 4.1 kg (SE 1.2, n 71) whereas the control group was almost unchanged with a weight loss of 0.2 kg (SE 1.2, n 66). Looking at the main outcome of serum urate levels change, the initial intensive diet resulted in a mean decrease of 0.21 mg/dL (95% CI 0.35 to 0.07, n 155) for the entire cohort. In the following year (week 0 to 52) the liraglutide group exhibited a further mean decrease in serum urate of 0.48 mg/dL (SE 0.11, n 69), whereas the placebo group exhibited a slight decrease in mean serum urate of 0.07 mg/dL (SE 0.12, n 65) resulting in a significant between-group difference of -0.40 mg/dL (95% CI -0.69 to -0.12, n 134) – see Figure 1. Four participants in each group experienced serious adverse events; no deaths were observed.Conclusion:This secondary analysis of the LOSE-IT trial suggests that liraglutide provides a potential novel serum urate lowering drug mechanism in obese patient populations, with potential implication for gout treatment.