ProGo Menopause Wellbeing Study

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.

NCT Number	NCT07611305
Lead Sponsor	Hofseth Biocare ASA Collaborators: Alethios, Inc.
Conditions	Menopause Related Conditions
Enrollment	100 participants
Start Date	2026-06
Primary Completion	2026-12 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-02