A Novel Approach to Weight Loss in Women Over 50 Years: Insights from RESET Study with a Shape-Shifting Hydrogel Capsule

Background: Women over the age of 50 often experience weight gain due to menopausal-related hormonal changes, increasing their risk for health complications. The Epitomee capsule, a nondrug medical device designed to enhance satiety, may offer significant benefits for weight loss in this demographic. Methods: This sub-analysis of the Randomized Evaluation of Efficacy and Safety of the Epitomee Capsule Trial (RESET) double-blind placebo-controlled study included 104 women aged ≥50, randomized to Epitomee capsule ( n = 52) or placebo ( n = 52) with lifestyle counseling. Outcomes included % weight loss (baseline to week 24), responder rates (≥5%, ≥10%, ≥15%), body mass index (BMI) change, early responder, waist circumference, and glycemic status. Results: Age and gender were not significant covariates influencing Epitomee capsule efficacy in the multivariate model of the RESET study. Among women aged ≥50 years, average weight reduction was 7.6% in the Epitomee group versus 4.4% in the placebo group ( P = 0.0287). Significantly more women treated with Epitomee achieved ≥5% weight loss (63% vs 42%, P = 0.0463), and ≥10% weight loss (29% vs 9%, P = 0.0169). Among women aged older than 50 years, early response (ER) was defined as a weight loss of ≥2% at week 8. ER, average weight reduction at week 24 was 9.9% of baseline body weight in the Epitomee group versus 6.2% in the placebo group ( P = 0.0074). The Epitomee group also showed greater reductions in BMI and waist circumference, along with more frequent shifts toward normoglycemia. Among women >50 years, a significantly greater proportion improved their BMI category compared with placebo (56% vs 21%, P = 0.0007). Adverse event rates were similar between groups, and no serious events occurred. Conclusions: The Epitomee capsule demonstrates significant efficacy in promoting weight loss, improving BMI, and a showing trend toward improved metabolic parameters in women over the age of 50, with a favorable safety profile, suggesting its potential as a valuable nonpharmaceutical intervention for the menopausal population.