Improvements In Lean Body Mass Research Articles

Pragmatic Approaches to Scalable Prehabilitation

Patients with cancer should ideally undergo proactive screening for muscle wasting, dietary deficiencies, functional changes, and/or psychological needs. Alternatively, a cross-referral strategy may be useful. A multimodal prehabilitation approach can address impairments and optimize function before treatment. Urological prehabilitation has led to improvements in lean body mass, bone density, erectile function, and urinary continence.

Efficacy and safety of anamorelin in patients with cancer cachexia: Post-hoc subgroup analyses of a placebo-controlled study.

Cachexia, a disorder associated with anorexia, inflammation, and muscle wasting, is frequent in cancer patients. We performed post-hoc analyses of the ONO-7643-04 study to investigate the efficacy and safety of anamorelin in subgroups of Japanese patients with non-small cell lung cancer (NSCLC). The patients were divided into subgroups by baseline characteristics, including sex, age, body mass index, prior weight loss, performance status (PS), concomitant anticancer therapy, and number of previous chemotherapy regimens. The changes from baseline through to 12 weeks for lean body mass (LBM), body weight, and appetite were calculated. Appetite was evaluated using the quality of life questionnaire for cancer patients treated with anticancer drugs (QOL-ACD) item 8 score. Responder rates were defined as the maintenance/improvement of LBM (≥0kg), body weight (≥0kg), or QOL-ACD item 8 score (≥0) from baseline to all evaluation time points. Safety was evaluated in patients subgrouped by age and PS. Anamorelin resulted in greater improvements versus placebo in LBM, body weight, and appetite in most subgroups. Anamorelin was also associated with greater LBM, body weight, and appetite responder rates than placebo in nearly all subgroups. Among anamorelin-treated patients, adverse drug reactions (ADRs) tended to be more frequent with increasing age (<65 years, 19.2%; ≥65 to <75 years, 45.9%; ≥75 years, 60.0%) and PS score (PS 0-1, 38.4%; PS 2, 60.0%). The frequency of serious ADRs was 2.7% and 0% in the PS 0-1 and PS 2 subgroups, respectively. This study of NSCLC patients with cancer cachexia revealed consistent improvements in LBM, body weight, and appetite across most subgroups of anamorelin-treated patients. This study also demonstrated the tolerability of anamorelin regardless of age and PS, with a low incidence of serious ADRs in each subgroup.

Effects of combined hip exercise and passive stretching on muscle stiffness, pain perception and painrelated disability, and physical function in older adults with low back pain.

This study aimed to examine the effects of combined hip exercise and passive stretching as a novel treatment method for low back pain (LBP) in older adults. Altogether, 20 Koreans with LBP aged 60-79 years (67.3 ± 5.92 years) were randomly assigned to undertake combined exercise (CE; n = 10) or lumbar stabilization exercise (LSE; n = 10). All participants performed their respective exercise program for 25-30 min with an OMNI scale of 6-8 for 8 weeks, three times a week. Body composition, muscle stiffness, pain-visual analog scale (P-VAS), Oswestry disability index, and physical function were evaluated before and after the exercise intervention. The CE group demonstrated greater improvements in lean body mass (η2 = 0.402, p = 0.003) and percent body fat (η2 = 0.222, p = 0.036) than the LSE group. Both groups demonstrated significant improvements in muscle stiffness, P-VAS scores, and Oswestry disability index scores, although no significant differences were observed between the interventions. All physical function parameters demonstrated a significant improvement in both groups, and the CE group demonstrated greater improvement in the YMCA sit-and-reach (η2 = 0.338, p = 0.007) and straight leg raise tests (η2 = 0.283, p = 0.016) than the LSE group. CE is comparable to LSE as an effective and successful exercise intervention that reduces muscle stiffness and P-VAS scores. Moreover, CE is more effective than LSE in enhancing the physical function of older adults with LBP.

Practical aspects of diabetes technology use: Continuous glucose monitors, insulin pumps, and automated insulin delivery systems

There have been tremendous advances in diabetes technology in the last decade. Continuous glucose monitors (CGM), insulin pumps, and automated insulin delivery (AID) systems aim to improve glycemic control while simultaneously decreasing the burden of diabetes management. Although diabetes technologies have been shown to decrease both hypoglycemia and hyperglycemia and to improve health-related quality of life in individuals with type 1 diabetes, the impact of these devices in individuals with cystic fibrosis-related diabetes (CFRD) is less clear. There are unique aspects of CFRD, including the different underlying pathophysiology and unique lived health care experience and comorbidities, that likely affect the use, efficacy, and uptake of diabetes technology in this population. Small studies suggest that CGM is accurate and may be helpful in guiding insulin therapy for individuals with CFRD. Insulin pump use has been linked to improvements in lean body mass and hemoglobin A1c among adults with CFRD. A recent pilot study highlighted the promise of AID systems in this population. This article provides an overview of practical aspects of diabetes technology use and device limitations that clinicians must be aware of in caring for individuals with CF and CFRD. Cost and limited insurance coverage remain significant barriers to wider implementation of diabetes technology use among patients with CFRD. Future studies exploring strategies to improve patient and CF provider education about these devices and studies showing the effectiveness of these technologies on health and patient-reported outcomes may lead to improved insurance coverage and increased rates of uptake and sustained use of these technologies in the CFRD community.

Kefir Is a Viable Exercise Recovery Beverage for Cancer Survivors Enrolled in a Structured Exercise Program.

This study investigated the effects of 12 wk of postexercise kefir consumption in cancer survivors who have undergone chemotherapy and/or radiation therapy. All participants were enrolled in a structured exercise training program and separated into kefir (KEF) or control (CON) treatment groups. KEF consumed 8 oz. of kefir after exercise sessions (3 d·wk-1) for 12 wk. Outcome measures included assessments for body size and composition, aerobic fitness and muscular strength, medical history, and psychological state at pre- and postintervention time points. Blood was collected and analyzed for C-reactive protein (CRP), interleukin 6 (IL-6), and lipopolysaccharide (LPS) concentrations, and LPS-stimulated whole blood IL-6 and tumor necrosis factor α production were obtained using enzyme-linked immunosorbent assays at both time points. Monocyte numbers and phenotype were obtained using flow cytometry. Participants (N = 24; 9 males and 15 females) were an average of 61 ± 9.9 yr old. Kefir consumption was associated with 6.3% (P = 0.034) improvements in lean body mass, as well as 51.4% (P = 0.046), 39.3% (P = 0.017), and 64.7% (P = 0.021) improvements in measures of depression, fatigue, and gastric distress, respectively. KEF also experienced a significant 35.4% (P = 0.01) reduction in circulating LPS along with an 18.0% increase (P < 0.001) in classical monocytes % and a 22.3% decrease (P = 0.04) in nonclassical monocytes %. There were no significant changes in any other variables. Twelve weeks of kefir consumption improved lean body mass, depression, fatigue, gastric distress, and a biomarker of gut dysbiosis. Kefir improved overall and classical monocyte numbers. Kefir should be considered as a component of a postexercise dietary regimen for cancer survivors.

Impact of Semaglutide on Body Composition in Adults With Overweight or Obesity: Exploratory Analysis of the STEP 1 Study

Background: Central obesity is associated with increased risk of cardiometabolic disease. Weight loss reduces lean muscle mass, potentially impacting resting energy expenditure and/or physical functioning. This analysis of the STEP 1 trial evaluated the impact of subcutaneous (s.c.) semaglutide, a glucagon-like peptide-1 analogue, on body composition in adults with overweight/obesity using dual energy X-ray absorptiometry (DEXA). Methods: In STEP 1, 1961 adults aged ≥18 years with body mass index (BMI) ≥27 kg/m2 with ≥1 weight-related comorbidity or BMI ≥30 kg/m2, without diabetes, were randomized to s.c. semaglutide 2.4 mg once-weekly or matched placebo (2:1) for 68 weeks, plus lifestyle intervention. Participants with BMI ≤40 kg/m2 from 9 sites were eligible for the substudy. Total fat mass, total lean body mass and regional visceral fat mass were measured using DEXA at screening and week 68; visceral fat mass was calculated in the L4 region (both males/females), android region (males), or gynoid region (females), depending on site scanner methodology. Proportions of total fat and lean body mass are shown relative to total body mass; proportion of visceral fat mass is expressed relative to region assessed. Results: This analysis included 140 participants (semaglutide n=95; placebo n=45) (mean weight 98.4 kg, BMI 34.8 kg/m2; 76% female). Baseline body composition was similar in those receiving semaglutide and placebo (total fat mass proportion: 43.4% vs 44.6%; regional visceral fat mass proportion: 33.8% vs 36.3%; total lean body mass proportion: 53.9% vs 52.7%; respectively). Percentage change in body weight from baseline to week 68 was -15.0% with semaglutide vs -3.6% with placebo. This resulted in reductions from baseline with semaglutide in total fat mass (-19.3%) and regional visceral fat mass (-27.4%), leading to 3.5%-point and 2.0%-point reductions in the proportions of total fat mass and visceral fat mass, respectively. Total lean body mass decreased from baseline (-9.7%); however, the proportion relative to total body mass increased by 3.0%-points. An increasing improvement in lean body mass:fat mass ratio was seen with semaglutide with increasing weight loss from baseline to week 68 (continuous data). Overall, the ratio increased from baseline (1.34 [95% CI: 1.22, 1.47]) to week 68 by 0.23 [0.14, 0.32], with greater improvement in those with ≥15% weight loss (n=44; 0.41 [0.28, 0.53]) vs <15% weight loss (n=39; 0.03 [-0.05, 0.12]) (observed, dichotomized data; no imputation for missing data). There were no major changes in body composition with placebo from baseline to week 68. Conclusion: In adults with overweight/obesity, semaglutide 2.4 mg was associated with reduced total fat mass and regional visceral fat mass, and an increased proportion of lean body mass. Greater weight loss was associated with greater improvement in body composition (lean body mass:fat mass ratio).

Pharmacological profile and clinical efficacy of anamorelin HCl (ADLUMIZ&lt;sup&gt;®&lt;/sup&gt;Tablets), the first orally available drug for cancer cachexia with ghrelin-like action in Japan

Anamorelin hydrochloride (hereinafter referred to as anamorelin) is an orally active, small-molecule drug with a similar pharmacological action to ghrelin, an endogenous ligand of growth hormone secretagogue receptor type 1a (GHS-R1a). It was first approved in Japan for the treatment of cancer cachexia, characterized by weight loss and anorexia. Anamorelin stimulated the secretion of growth hormone (GH) from cultured rat pituitary cells and increased plasma GH levels by oral administration to rats, pigs and humans. When anamorelin was orally administered once daily for 6 days to rats, larger body weight gain associated with increased food consumption compared to the control group was observed from after the first dose. Anamorelin is a selective agonist for GHS-R1a and enhanced GHS-R1a-mediated pituitary GH secretion and increased food consumption, resulting in body weight gain. In the two Japanese phase II studies in patients with cancer cachexia associated with non-small cell lung cancer (NSCLC), improvement of lean body mass (LBM) and body weight losses and anorexia were demonstrated. The tumor types of target patients in the Japanese phase III study were colorectal, gastric, and pancreatic cancer. As a result, maintenance and increase of LBM and body weight as well as improvement of anorexia were observed, and the efficacy against cancer cachexia associated with colorectal, gastric, and pancreatic cancer was confirmed. There were no observed events considered to be significant safety risks. In conclusion, anamorelin is expected to provide a new therapeutic option for cancer cachexia for which no effective treatment has been available.

Effect of testosterone replacement therapy on insulin sensitivity and body composition in congenital hypogonadism: A prospective longitudinal follow-up study.

Aims:To evaluate the prevalence of metabolic syndrome (MS) and whole-body composition in patients with congenital hypogonadism and investigate the effects of replacement therapy with testosterone undecanoate on MS, insulin resistance (IR), and whole-body composition in subset of patients.Methods:In a single arm prospective longitudinal intervention study, 33 patients with congenital hypogonadism, ages 20–39 years, were recruited and their parameters of MS, whole-body composition by DXA were compared with age and BMI matched healthy controls. In 21 patients, after 9 months we prospectively studied the effect (pre–post difference) of injection testosterone undecanoate (1,000 mg) replacement on MS, IR, and whole-body compositions.Results:The prevalence of MS was similar in patients and controls (27.3% vs. 9.1%, P = 0.05). Hypogonadism patients had higher prevalence of hypertension (33% vs. 3%, P < 0.01). Patients had decrease in lean body mass (P < 0.05) as compared to controls. After testosterone replacement, there was significant decrease in waist circumference (88.6 ± 13.1 cm vs. 83.9 ± 12.9 cm, P < 0.01), truncal fat (25.9 ± 7.3% vs. 24.0 ± 6.3%, P < 0.05), fasting C-peptide (2.1 ± 0.79 ng/ml vs. 0.68 ± 0.23 ng/ml, P < 0.01), serum proinsulin [1.43 (0.32– 13.4) vs. 0.5 (0.5–3.2) pmol/l, P < 0.001] and a significant increase in lean body mass (46,906 ± 8,876 gm vs. 50,083 ± 7,590 gm, P < 0.001). Homeostasis model assessment of insulin resistance (HOMA-IR) (4.6 ± 1.7 vs. 0.5 ± 0.2, P < 0.001) and homeostatic model for assessment of insulin sensitivity (HOMA%S) [21 (12–65) vs. 206 (125–714), P < 0.001] were improved significantly following testosterone replacement.Conclusion:In this study, 36 weeks of testosterone replacement resulted in significant decrease in waist circumference, IR, truncal fat, total body fat and improvement in lean body mass, and insulin sensitivity.

The regulatory approval of anamorelin for treatment of cachexia in patients with non‐small cell lung cancer, gastric cancer, pancreatic cancer, and colorectal cancer in Japan: facts and numbers.

Anamorelin is a ghrelin receptor agonist that can be administered orally and thought to improve cancer cachexia by improving appetite and increasing serum insulin‐like growth factor‐1. Anamorelin was not approved for use in Europe. In contrast, the use of anamorelin for cancer cachexia in four types of cancer (non‐small cell lung cancer, gastric cancer, pancreatic cancer, and colorectal cancer) was approved in Japan on 11 December 2020. Phase 2 trial (ONO‐7643‐04) for the treatment of patients with non‐small cell lung cancer and cachexia resulted in 1.56 kg lean body mass increase assessed by dual‐energy X‐ray absorptiometry (DXA). Another study for advanced and unresectable gastrointestinal (colorectal, gastric, or pancreatic) cancer showed 1.89 ± 0.36 kg improvement in lean body mass. Skeletal lean body mass assessed by DXA is important for diagnosing sarcopenia and cachexia in Asia. The approval of anamorelin is expected to change clinical practice of cancer cachexia in Japan and hopefully in other countries. In the past, cachexia was rarely diagnosed in Japan, because it was often thought that cachexia meant terminal stage. The dissemination of clinical findings on anamorelin from Japan, as well as the creation of consensus papers and clinical practice guidelines for cachexia in Japan and Asia, will be required to promote international expansion in the future.

RETRACTED: High protein diet improves the overall survival in older adults with advanced gastrointestinal cancer

High protein diet (HDP) promotes improvement of lean body mass in elderly without cancer; but the impact of high protein intake on muscle strength and mortality in cancer patients remains to be elucidated. This study evaluates the association between HPD on handgrip strength (HGS) and survival in older adults outpatients with advanced gastrointestinal cancer. Ninety-one patients with advanced gastrointestinal cancer (>65% tumor stage III-IV) undergoing radiotherapy, chemotherapy or surgery were enrolled. Upon first oncological visit, tumor stage was assessed by a physician. Then, a nutritionist or a dietitian measured the body mass index (BMI), HGS by means of a dynamometer, and dietary food intake by using 24h food recall. Patients were stratified in HPD (i.e, ≥1.5g/kg/d) or low protein diet (LPD: <1.5g/kg/d). Kaplan-Meier curve was used to assess the survival since the cancer diagnosis. HPD was reported by approximately 30% of patients. Protein intake was significantly higher in HPD vs LPD patients (2.2±0.8 vs. 0.8±0.4g/kg/d, respectively; p<0.0001). No significant association was found between HPD and HGS, even after adjustment for physical activity, alcohol intake, smoking, sex, age, tumor stage, oncologic treatment and BMI (OR: 0.97 [95%CI: 0.88-1.08], p=0.64), or for energy intake kcal/kg/day, leucine g/d and lipids g/d (OR: 0.93 [95%CI: 0.85-1.03, p=0.19]. In addition, HPD group showed higher overall survival than LPD group (HPD: 14.7 vs. LPD: 7.3 months, p=0.04). HPD is not associated with better muscle function as measured by HGS, but with overall survival in older adults outpatients with advanced gastrointestinal cancer. HPD may represent a strategy to mitigate the cancer-induced mortality and should be further explored.

Effects Of Exercise On Disablement Process Outcomes In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy: An Updated Systematic Review

Although androgen-deprivation therapy (ADT) is a foundation of treatment for prostate cancer (PCa) patients, adverse effects of ADT may accelerate functional decline. Whereas exercise improves muscular strength and functional performance in PCa patients, evidence of the benefits of exercise for alternative disablement process outcomes remain equivocal. PURPOSE: To update the findings of our previous systematic review of the effects of exercise on disablement process outcomes in PCa patients undergoing ADT. The purpose of this study is to determine the extent to which exercise interventions produce meaningful improvements in the specific impairment domain outcome of body composition (BC) in PCa patients on ADT. METHODS: A comprehensive literature search was conducted of all relevant published studies from December 2013-present. Data were extracted on BC outcomes from 8 published exercise intervention studies involving 307 PCa patients on ADT. The magnitude of pre- to post-intervention change was examined. To isolate the effects of exercise, studies combining other interventions were excluded. Weighted, bias-corrected Cohen’s d effect sizes were calculated for change in each outcome and averaged across included studies. RESULTS: Results revealed that exercise yielded small average improvements in lean body mass (d = 0.09), appendicular lean mass (d = 0.08), trunk fat mass (d = -0.03) and visceral fat mass (d = -0.11). All other measures of whole-body and regional BC showed negligible average effects of exercise. CONCLUSIONS: The findings of this updated systematic review suggest that while exercise attenuates the established adverse effects of ADT on BC, the magnitude of exercise-induced improvements in BC outcomes is small and inconsistent across studies. These findings have important implications for delineating the effect of exercise on disablement process outcomes and underscore the potential utility of complementing exercise with targeted nutritional approaches in the supportive care of PCa patients on ADT.

Improvements in muscle strength, power, and size and self-reported fatigue as mediators of the effect of resistance exercise on physical performance breast cancer survivor women: a randomized controlled trial.

To gain more knowledge about the mechanism (i.e., mediators) of resistance exercise (RE)-induced improvements in physical performance (PP), we seek to investigate whether improvements in muscle strength (MS), muscle power (MP), and lean body mass (LBM) and (or) self-reported fatigue (SRF) are mediators of the effect of RE on PP in breast cancer survivor women (BCSW). The volunteers were randomly divided into two groups: control group (CT; n = 9) and resistance exercise (RE; n = 11). The RE protocol consisted of three sets in each exercise (leg extension, leg curl, 45° leg press, and calf raise), between 8 and 12 repetitions per set, with an estimated load of 80% of one-repetition maximum (1RM), and three times a week on non-consecutive days for 12weeks. The CT group performed only stretching exercises twice a week. SRF, maximal muscle power (Pmax), MP, LBM, and PP were assessed using the Brief Fatigue Inventory Questionnaire; 1RM test; isoinertial dynamometer; DXA; and walking speed, sit-to-stand (STS), and timed up and go (TUG) test, respectively. Following 12weeks, the RE group reduced SRF and increased MP, Pmax, LBM, and performance in all tests (walking speed, STS, and TUG) when compared with the CT group. There were significant associations of the changes in LBM, MS, Pmax, and SRF with changes in physical performance tests only in the RE group. Our findings suggest that improvements in LBM, MS, MP, and self-reported fatigue mediate the effect of resistance exercise on physical performance in BCSW.

A prospective trial of elemental enteral feeding in patients with pancreatic cancer cachexia (PANCAX-1).

726 Background: Unintentional weight loss affecting &gt; 85% of pancreatic cancer (PC) patients contributes to low therapeutic tolerance, reduced quality of life, and overall mortality. Optimal treatment approaches have not been developed. We hypothesize that peptide-based enteral nutritional support in cachectic advanced PC patients, receiving palliative chemotherapy, results in improved weight, lean body mass (LBM), and hand-grip strength. Methods: Pancreatic adenocarcinoma patients with cachexia (&gt; 5% unintentional weight loss within the previous 6 months) were provided a jejunal tube peptide-based diet for 3 months. Primary outcome was weight stability (0.1kg/BMI unit decrease). Secondary outcomes included changes from baseline in LBM, bone mineral density (BMD), total body fat mass (BFM), handgrip strength, physical activity (Fitbit), and CA19-9 and CRP. Planned interim analysis was performed after 14 patients completed treatment. Results: From 31 consenting patients, 16 were evaluable for the primary outcome. Patients receiving enteral therapy were 39% male, median age 69 (Range: 41 to 89 years), and 74% ECOG 1. A summary of change in outcomes at 3 months from baseline is shown in Table. The primary endpoint of weight stability in 10 (62.5%) patients was met, thus completing study. Overall survival was 6.5 months (n=31) and 9.9 months for evaluable patients (n=16). Weight stability was statistically associated with LBM (Pearson’s correlation: 0.87, p&lt;0.001), but not survival (HR: 0.94, 95% CI 0.32, 2.83, p=0.92). Conclusions: Peptide-based enteral feeding resulted in weight stability and improvements in lean body mass and physical function. Further randomized trials assessing nutritional support in advanced patients are warranted. NIH/NCATS Grant # UL1TR000124. Clinical trial information: NCT02400398 . [Table: see text]

The Effect of Low-Volume High-Intensity Interval Training on Body Composition and Cardiorespiratory Fitness: A Systematic Review and Meta-Analysis.

Evidence for the efficacy of low-volume high-intensity interval training (HIIT) for the modulation of body composition is unclear. We examined the effect of low-volume HIIT versus a non-exercising control and moderate-intensity continuous training (MICT) on body composition and cardiorespiratory fitness in normal weight, overweight and obese adults. We evaluated the impact of low-volume HIIT (HIIT interventions where the total amount of exercise performed during training was ≤ 500 metabolic equivalent minutes per week [MET-min/week]) compared to a non-exercising control and MICT. A database search was conducted in PubMed (MEDLINE), EMBASE, CINAHL, Web of Science, SPORTDiscus and Scopus from the earliest record to June 2019 for studies (randomised controlled trials and non-randomised controlled trials) with exercise training interventions with a minimum 4-week duration. Meta-analyses were conducted for between-group (low-volume HIIT vs. non-exercising control and low-volume HIIT vs. MICT) comparisons for change in total body fat mass (kg), body fat percentage (%), lean body mass (kg) and cardiorespiratory fitness. From 11,485 relevant records, 47 studies were included. No difference was found between low-volume HIIT and a non-exercising control on total body fat mass (kg) (effect size [ES]: - 0.129, 95% confidence interval [CI] - 0.468 to 0.210; p = 0.455), body fat (%) (ES: - 0.063, 95% CI - 0.383 to 0.257; p = 0.700) and lean body mass (kg) (ES: 0.050, 95% CI - 0.250 to 0.351; p = 0.744), or between low-volume HIIT and MICT on total body fat mass (kg) (ES: - 0.021, 95% CI - 0.272 to 0.231; p = 0.872), body fat (%) (ES: 0.005, 95% CI - 0.294 to 0.304; p = 0.974) and lean body mass (kg) (ES: 0.030, 95% CI - 0.167 to 0.266; p = 0.768). However, low-volume HIIT significantly improved cardiorespiratory fitness compared with a non-exercising control (p < 0.001) and MICT (p = 0.017). These data suggest that low-volume HIIT is inefficient for the modulation of total body fat mass or total body fat percentage in comparison with a non-exercise control and MICT. A novel finding of our meta-analysis was that there appears to be no significant effect of low-volume HIIT on lean body mass when compared with a non-exercising control, and while most studies tended to favour improvement in lean body mass with low-volume HIIT versus MICT, this was not significant. However, despite its lower training volume, low-volume HIIT induces greater improvements in cardiorespiratory fitness than a non-exercising control and MICT in normal weight, overweight and obese adults. Low-volume HIIT, therefore, appears to be a time-efficient treatment for increasing fitness, but not for the improvement of body composition.

Four Months of a School-Based Exercise Program Improved Aerobic Fitness and Clinical Outcomes in a Low-SES Population of Normal Weight and Overweight/Obese Children With Asthma.

Introduction: Fitness can improve asthma management. However, children from disadvantaged and minority communities generally engage less in physical activity, and have increased obesity and asthma disease burden. The goal of this pilot study is to evaluate (1) the feasibility of an exercise intervention program in a school-based setting (attendance and fitness improvement) and (2) the effect of the intervention on fitness, asthma, and clinical outcomes in normal weight and overweight/obese children with asthma from low-SES population.Materials and Methods: Nineteen children, ages 6–13 years, from two elementary schools in Santa Ana, CA, a population with high percentage of Hispanic and low socioeconomic status, participated. Training sessions occurred at the schools during afterschool hours (3 sessions weekly × 4 months) and included mainly aerobic age-appropriate activities/games and a small component of muscle strength. Before and after the intervention, evaluations included pulmonary function testing, cardiopulmonary exercise testing (peak O2), assessments of habitual physical activity, body composition (DXA), asthma questionnaires, and blood (cardiometabolic risk factors).Results: Seventeen of 19 participants completed the study. Adherence to the program was 85%. Based on BMI %ile, 11 of the participants were overweight/obese and 8 were normal weight. Ten participants had persistent asthma and 9 children had intermittent asthma. Training was effective as peak O2 improved significantly (8.1%, SD ± 10.1). There was no significant change in BMI %ile but a significant improvement in lean body mass (1%, SD ± 2.0) and decrease in body fat (1.9%, SD ± 4.6). Asthma quality of life outcomes improved following the intervention in symptoms, emotional function, and overall. There was no change in asthma control or pulmonary function. Five of 10 participants with persistent asthma decreased their maintenance medications. Lipid levels did not change except HDL levels increased (46.1 ± 8.4 mg/dL to 49.5 ± 10.4 mg/dL, p = 0.04).Discussion: A school-based exercise intervention program designed specifically for children with asthma for a predominantly economically disadvantaged and minority population was feasible with good adherence to the program and substantial engagement from the schools, families and participants. The exercise intervention was effective with improvement in aerobic fitness, body composition, asthma quality of life, and lipid outcomes, setting the stage for a larger multicenter trial designed to study exercise as an adjunct medicine in children with asthma.

Furosap, a novel Fenugreek seed extract improves lean body mass and serum testosterone in a randomized, placebo-controlled, double-blind clinical investigation

Background: The Indian spice fenugreek (Trigonella foenum-graecum) has been credited with numerous health benefits in cardiovascular disorders, metabolic syndrome, inflammatory conditions, glucose-insulin regulation, and sports performance. Previous studies from our laboratories demonstrated that fenugreek seed extract improved glucose tolerance, insulin sensitivity, augmented serum testosterone level and improved cardiovascular functions. Our investigation examined the efficacy of Furosap, a novel fenugreek seed extract enriched in 20% protodioscin, on exercise performance. Methods: This randomized, double-blind, placebo-controlled, clinical study was conducted in forty healthy male athletes (n = 40) over a period of 12 consecutive weeks. Subjects were given either placebo or Furosap capsules (250 mg/day b.d.) and serum samples were used to assess serum total testosterone level and C-reactive proteins (CRP) at baseline and at the end of 12-weeks of treatment. Body fat mass, lean mass, fat mass, fat-free mass, grip strength, upper and lower body strength, maximal graded exercise stress using a digital hand dynamometer, dual-energy X-ray absorptiometry (DEXA), force plate, and treadmill with open-circuit spirometry were assessed at the baseline and at the end of 12-weeks of treatment.Results: Furosap supplementation significantly increased mean lean body mass and fat-free mass compared to subjects receiving placebo. Additionally, Furosap-treated subjects elevated serum testosterone levels. Furosap supplemented subjects also exhibited a tendency towards lowering blood pressure during exhaustion. No adverse reports were reported.Conclusions: Given improvement of lean body mass and serum total testosterone following intervention with Furosap, Furosap likely has benefits for exercise endurance and sports medicine. Keywords: Fenugreek seed extract; safety; body mass; fat-free mass; blood pressure; muscle strength.

P098 RELATIONS BETWEEN HEALTH BEHAVIORS, BODY COMPOSITION AND DISEASE STATUS IN PEDIATRIC PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Lean body mass (LBM) deficits in youth with Inflammatory Bowel Disease (IBD) are well-established and persist despite achievement of remission and restoration of body mass. LBM deficits are associated with both short and long-term health outcomes including sarcopenia, metabolic dysregulation, and development of osteopenia/osteoporosis. LBM deficits are multifactorial though largely explained by inflammatory processes, inadequate dietary intake, and increased energy needs. Physical activity (PA) may also play a role in LBM deficits. Unfortunately, PA and diet in youth with IBD have been understudied. The present cross-sectional study describes relations between PA, diet, body composition, and disease status in a sample of youth with IBD. 40 patients with IBD aged 8-17 (M=14.58 years; 60% female; 78% Caucasian; 60% Crohn’s) completed the study. Measures included: Moderate to Vigorous PA (MVPA; Godin Leisure Time Exercise Questionnaire), Diet (4-day Food Record), Body Composition and Bone Mineral Density (BMD; Dual-energy X-ray Absorptiometry), and Disease Status (Physician Global Assessment). Analyses included independent samples t-test and two-tailed pearson correlations. Data collection is ongoing. No differences were found on variables based on group. Correlational analyses (N = 40) revealed that greater MVPA was associated with higher LBM (r = .39) and lower fat mass (r = -.38). Average percent protein intake was associated with older age (r = .38), lower percent carbohydrate intake (r = -.72) and higher BMD (r = .37). Less active disease was associated with higher BMI (r = -.38), higher BMD (r = -.46), and higher LBM (r = -.48). Interestingly, disease status was not associated with health behavior engagement. The present study suggests the need for further research into physical activity and diet as a means of improving outcomes for pediatric patients with IBD through improvements in LBM.

MABp1 for the treatment of colorectal cancer

ABSTRACTIntroduction: Inflammation is an established process in colorectal cancer development and a hallmark of progression, and pro-inflammatory cytokines have been implicated in the morbidity and functional compromise associated with malignancy. MABp1, described as a first-in-class true human antibody against interleukin-1α, has undergone clinical trial evaluation in a number of indications, recently completing late phase clinical trial testing under Fast Track designation for cancer anorexia-cachexia syndrome in colorectal cancer patients. To date, MABp1 has been evaluated as a novel therapeutic strategy to ameliorate phenotypic factors associated with poor prognosis in colorectal cancer patients.Areas covered: In this review, the authors discuss the clinical trial data available to date for this antibody in colorectal cancer, including novel clinical trial endpoints utilized to evaluate sarcopenia and inflammation, as well as the proposed role of interleukin-1α antagonism in leading to improved patient outcomes.Expert opinion: There is a multitude of antibodies in therapeutic development in oncology, and MABp1 is a novel class of antibody which has been safely tolerated to date. Clinical studies of this agent suggest a significant improvement in lean body mass, though additional results evaluating the impact of targeting inflammation as a strategy to delay disease progression in this population are awaited.

MABp1 to improve clinical outcomes of patients with symptomatic refractory metastatic colorectal cancer patients: Per-protocol population analysis of phase III study (PT026).

3530 Background: Refractory metastatic colorectal cancer (mCRC) patients derive minimal benefit from further exposure to toxic agents. MABp1 is an anti-interleukin 1 alpha antibody that is shown to prolong survival (NCT01767857) and improves outcomes when assessed with a primary endpoint based on a constellation of objective and patient self-reported measures (NCT02138422) (Hickish T. et al Lancet Oncology 2017). In the latter study, clinically advanced patients were enrolled (symptomatic, ECOG 1,2), and 18% of patients progressed prior to reaching the endpoint assessments. Here we present the outcomes in per-protocol population (PP), those patients completing week 8 assessments. Methods: 309 patients randomized 2:1 to receive MABp1 versus placebo. Patients were ECOG 1-2, with mCRC refractory to chemotherapy, any degree of weight loss, and cancer-associated symptoms. The composite primary endpoint assessed the rate of patients achieving stabilization or improvement in lean body mass (LBM) and two of three symptom measures (pain, fatigue, appetite loss) from screening to the week 8 assessment. The study was designed for placebo cross-over, thus OS analysis for MABp1 vs placebo was not possible. Results: 57 patients (38 MABp1 [18%] and 19 placebo [19%]) discontinued study prior to the week 8 assessment due to disease progression, including 17 (8%) and 11 (11%) deaths in MABp1 and placebo respectively. 62% of placebo patients received MABp1 after 8 weeks. 252 patients, 40% in MABp1 (68/169) vs 23% in placebo (19/83) met the primary endpoint (p = 0.003). 139 patients were available for PP survival analysis (90 MABp1 vs 49 Placebo). Median OS of those achieving the primary endpoint was 11.7 months vs 5.7 months for those that did not (HR 0.39; p &lt; 0.0001). Radiographic stable disease was improved (42% vs 12%; p &lt; 0.001) and incidence of SAEs (6% vs 15%; p = 0.11) reduced in those achieving the primary endpoint. Conclusions: Achieving the primary endpoint was associated with improvement in outcomes, RECIST stabilization, SAEs and survival. Further study should confirm the effect of MABp1 on survival in this population. Clinical trial information: NCT02138422.

Effects of a 1-year randomised controlled trial of resistance training on blood lipid profile and chylomicron concentration in older men.

Resistance exercise is promoted in older adults for its ability to improve muscle mass, strength and, hence, in reducing falls. However, its effects on blood lipids and CVD risk are less well established, particularly in this age group. This study aimed to investigate whether a 1-year resistance exercise program improves lipid profile and chylomicron concentration in older men. Participants were randomised to either three, 1h resistance training sessions per week (RE) or an active control group [asked to undertake three 30min walking sessions per week (AC)]. Fasting blood samples were collected at 0, 6, and 12months for determination of lipid profile and glycaemic control. Diet, morphological and activity data were also collected at these time points. Following 12months, the RE intervention group had greater improvements in cholesterol profile; LDL-cholesterol concentration significantly decreased by 0.2 (0.2)mM [mean (SEM)] compared to control (P<0.05). The RE group also exhibited a significant increase in lean body mass of 0.9 (1.3)kg after 12months compared to the AC group (P<0.05). There was no treatment or time effect on other anthropometric measures or fasting triacylglycerol, glucose, insulin or chylomicron concentrations. The observed improvements in lean body mass and cholesterol profile promote the implementation of a resistance exercise intervention in this population.