4.3 EFFECT OF LURASIDONE ON BODY WEIGHT AND LABORATORY PARAMETERS IN ADOLESCENT PATIENTS WITH SCHIZOPHRENIA: RESULTS FROM A 6-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

2016 ◽  
Vol 55 (10) ◽  
pp. S163
Author(s):  
Robert S. Goldman ◽  
Adelaide S. Robb ◽  
Robert M. Silva ◽  
Josephine B. Cucchiaro ◽  
Ling Deng ◽  
...  
Keyword(s):  
Body Weight ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Laboratory Parameters ◽  
Adolescent Patients

scholarly journals Effect of Citrulline and Leucine Intake with Exercises on Body Composition, Physical Activity, and Amino Acid Concentration in Older Women: A Randomized Double-Blind Placebo-Controlled Study

Foods ◽  
2021 ◽  
Vol 10 (12) ◽  
pp. 3117
Author(s):  
Mijin Kim ◽  
Hiroko Isoda ◽  
Tomohiro Okura
Keyword(s):  
Physical Activity ◽  
Body Composition ◽  
Body Weight ◽  
Amino Acid ◽  
Older Women ◽  
Body Mass ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Amino Acid Concentrations

The combined intake of citrulline (CIT) and leucine (LEU) can stimulate protein synthesis. Therefore, this study aimed to investigate the effect of combined intake of CIT and LEU accompanied by exercise for 20 weeks on body composition, physical activity (PA), and amino acid concentrations in older Japanese women with low body mass index (BMI) (16 to 21 kg/m2) using a randomized, double-blind, placebo-controlled design. The supplement was administered twice a day for 20 weeks (Ex (exercise) + CIT·LEU group, n = 10: mainly 0.8 g CIT and 1.6 g LEU; Ex + Placebo group, n = 13: mainly 3.5 g carbohydrate). Additionally, both groups exercised (weight-bearing exercise, square stepping exercise) once a week for 75 min. Body composition, PA, and amino acid concentrations in the plasma were measured. Body weight, BMI, body mass, household PA, total PA, and phenylalanine significantly increased in the Ex + CIT·LEU group (p < 0.05) post intervention. This study suggests that the combined intake of CIT and LEU accompanied by exercise can improve body weight, BMI, body mass, and PA in older women with low BMI, which may prevent sarcopenia and frailty.

scholarly journals A randomized, double-blind, placebo-controlled study of liraglutide 3 mg [LIRA 3mg] on weight, body composition, hormonal and metabolic parameters in women with obesity and polycystic ovary syndrome (PCOS)

2021 ◽  
Author(s):  
Karen Elkind-Hirsch ◽  
Neil Chappell ◽  
Donna Shaler ◽  
John Storment ◽  
Drake Bellanger
Keyword(s):  
Body Composition ◽  
Body Weight ◽  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Controlled Study ◽  
Ovary Syndrome ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Placebo ◽  
Change In Mean

Abstract BackgroundThe efficacy of lifestyle modifications for established obesity is limited in women with polycystic ovary syndrome (PCOS) and more aggressive interventions are needed. We assessed the efficacy and safety of the GLP-1 analogue liraglutide 3mg (LIRA 3mg) versus placebo (PL) for reduction of body weight and hyperandrogenism in women with obesity and PCOSMethodsThis randomized, double-blind, placebo-controlled study enrolled women from a single-outpatient center diagnosed with PCOS (NIH criteria) with a body-mass index of at least 30 kg/m.2 Participants were randomly allocated (2:1) to treatment with a subcutaneous injection LIRA 3mg or visually matching placebo, once daily for 32 weeks, plus lifestyle intervention. Study visits at baseline, and 32 weeks included weight, blood pressure (BP), waist (WC) measures and body composition evaluated by dual-energy X-ray absorptiometry (DXA). Oral glucose tolerance tests (OGTT) were done to assess glycemia, mean blood glucose (MBG), and compute insulin sensitivity (SI) and secretion (IS) measures. Sex steroids, free androgen index (FAI), complete metabolic profile and lipid profiles were measured in the fasting sample. Co-primary endpoints were change in body weight (BW) and FAI. Safety was assessed in all patients who received at least one dose of study drug. This study was registered with ClinicalTrials.gov NCT03480022FindingsFrom October 2018 to June 2020, 88 patients were screened, of whom 82 were randomly assigned to LIRA 3mg (n = 55) or PL (n = 27). Change in mean BW from baseline to week 32 was − 5.7% (SE 0·.75) with LIRA 3mg vs. -1.4% (1.09) with PL (P < 0.002). At week 32, more patients on LIRA 3 mg than on placebo achieved weight reductions of at least 5% (25[57%] of 44 vs. 5 [22%] of 23; (p < 0·007). LIRA 3mg resulted in significant reduction of FAI, improvements in SI and IS as well as OGTT MBG, and improved body fat by DXA. Gastrointestinal adverse events, which were mostly mild to moderate, were reported in 32 (58.2%) of 55 patients with LIRA 3mg, and 5 (18.5%) of 27 with PL.InterpretationIn obese women with PCOS, LIRA 3mg once daily achieved a superior and clinically meaningful decrease in BW and androgenicity and improved cardiometabolic parameters compared with placebo.

A Randomized, Double-Blind, Placebo-Controlled Study of a Blend of Herbal Extracts Taken Once Per Day for Weight Loss in Healthy Volunteers

2019 ◽  
pp. 1-8
Author(s):  
Eli Kassis
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Waist Circumference ◽  
Health And Safety ◽  
Controlled Study ◽  
Herbal Extracts ◽  
Double Blind ◽  
Release Formulation ◽  
Double Blind Placebo ◽  
Preclinical And Clinical Studies

Aims: We previously demonstrated that a blend of herbal extracts (Weighlevel®; a mixture of extracts from the leaves of Alchemilla vulgaris, Olea europaea, Mentha longifolia and from the seeds of Cuminum cyminum) taken 3 times per day produces weight loss in preclinical and clinical studies. The aim of the present study was to test the efficacy of a new slow-release formulation (Weighlevel® One) taken once per day on change in body weight and related measures. Study Design:  Randomized, double-blind, placebo-controlled study. Place and Duration of Study: Health Clinics in Copenhagen, Denmark between 7 January 2016 and 5 March 2016. Methodology: Thirty-six adult subjects were randomized to consume the herbal blend (n = 20) or placebo (n = 16) once per day for 8 weeks. Weight and waist circumference were assessed weekly. The primary endpoint was the change from baseline in body weight for the herbal blend group compared with placebo. Secondary assessments included waist circumference, appetite, craving, bowel health, and safety and tolerability. Results: After 8 weeks, the herbal blend group lost an average of 3.7 kg (95% CI of 3.0 to 4.5 kg); whereas the placebo group lost 0.1 kg (95% CI of -0.7 to 1.0 kg). This difference in mean weight loss between the herbal blend and placebo groups was statistically significant (P <.001). A statistically significant reduction in waist circumference was also observed for the herbal blend compared with placebo (P <.001). The herbal blend was well tolerated; no adverse events were reported. Conclusion: Daily administration of this blend of herbal extracts, administered once daily, may produce weight loss.

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