A Decentralized, Randomized, Placebo-Controlled Trial Evaluating ProGo® Salmon Protein Hydrolysate Versus Placebo to Improve Body Profile Metrics and Support Overall Wellbeing in Menopausal Women
Hofseth Biocare ASA
Summary
This study will evaluate whether ProGo®, a salmon protein hydrolysate (SPH), helps to moderate body mass index (BMI) and improve quality of life (QoL) in menopausal women. Healthy, overweight (BMI 25-32.5) menopausal women aged 40-65 years with will be enrolled and participants will be randomized to receive ProGo® (2.0 g), ProGo® (4.0 g), or placebo (in a 2:2:1 ratio) once daily for 18 weeks. ProGo® peptides have demonstrated moderate weight loss of 6%-7% in prior human studies likely a result of improved energy levels and reduced inflammation with improved metabolic health. This study will assess the efficacy of ProGo® with change in BMI and menopause-specific quality of life (MENQoL total score) as co-primary endpoints. Secondary outcomes will explore anthropometric measures, skin health, appetite, sleep, physical activity, vasomotor symptoms, and selected blood biomarkers. The trial employs a fully decentralized design to enhance accessibility and support real-world relevance.
Description
The menopause transition (MT) is the phase leading up to menopause. Menopause is defined as 12 consecutive months without menstruation in the absence of other causes and marks the end of reproductive function, with the final menstrual period (FMP) reflecting cessation of ovarian follicular activity. The menopause is variable in its onset, overall length, severity of symptoms, and impact on functioning, and irregular ovulation and fluctuating estrogen and progesterone levels, gives rise to a broad spectrum of symptoms including hot flashes, night sweats, weight gain and musculoskeletal pain. Wo…