ProGo Menopause Wellbeing Study

Part of paid clinical trials in San Francisco, California.

Sponsor
Hofseth Biocare ASA
Study ID
NCT07611305
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Menopause Related Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Salmon protein hydrolysate (SPH) powder formulated into a tablet format — DIETARY_SUPPLEMENT
    Salmon protein hydrolysate containing a mix of peptides derived from freshly filleted Norwegian Atlantic salmon using a proprietary mix of non-genetically modified organism (GMO)-derived, natural peptidase enzymes.
  • Microcrystalline Cellulose — DIETARY_SUPPLEMENT
    Matching placebo tablets consisting of microcrystalline cellulose

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 2.0g per day ProGo
    ProGo is a salmon protein hydrolysate which will be administered in a tablet format
  • Experimental: 4.0g per day ProGo
    ProGo is a salmon protein hydrolysate which will be administered in a tablet format
  • Placebo Comparator: Matched placebo 2.0g
    Placebo tablets containing microcrystalline cellulose
  • Placebo Comparator: Matched placebo 4.0g
    Placebo tablets containing microcrystalline cellulose

Primary Outcome Measure

Change in body mass index (BMI) [ Time Frame: 18 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Alethios, Inc.San FranciscoCalifornia94109-

Find similar trials in San Francisco, CA

By research site
Alethios, Inc.· San Francisco, CA

Related Studies