NCT04014296.

Study name	Weight loss in adults over 50 with obesity
Methods	Randomised trial (parallel assignment)
Participants	Females, ages > 50 years, post‐menopausal with a BMI of 35 to 50 kg/m2. Exclusion criteria included: untreated hyper or hypotension, cancer (except basal cell), gastrointestinal disorders affecting food intake, > 6 months of stable use of medications that affect metabolism, body weight, energy expenditure or appetite, current eating disorder (e.g. binge eating disorder, anorexia, or bulimia) and any medical condition for which following a HP diet, and/or 70 minutes of exercise daily would be inadvisable.
Interventions	Intervention ‐ High‐protein diet: 16‐week weight loss programme with high‐protein diet and supervised flexibility and balance training. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%. Control ‐ Resistance training: 16‐week weight‐loss programme with normal protein diet and supervised resistance training. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:20%:26%.
Outcomes	Primary outcomes: 1) change in fat mass (baseline to 8 and 16 weeks), 2) change in fat free mass (baseline to 8 and 16 weeks) Secondary outcomes: 1) change in glucose, 2) change in insulin, 3) change in lipids, 4) change in disposition index (oral glucose tolerance testing), 5) change in aerobic fitness, 6) change in physcial activity, 7) change in muscle health and overall strength (all: baseline to 8, 16 and 52 weeks) 8) change in body composition (16 to 52 weeks)
Starting date	March 2020
Contact information	Caroline Cohen, PhD, 2059349213, cwyoder@uab.edu
Notes	Prospectively registered