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ProGo Menopause Wellbeing Study

NCT07611305 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-28

No results posted yet for this study

Summary

This study will evaluate whether ProGo®, a salmon protein hydrolysate (SPH), helps to moderate 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.

Conditions

  • Menopause Related Conditions

Interventions

DIETARY_SUPPLEMENT

Salmon protein hydrolysate (SPH) powder formulated into a tablet format

Salmon protein hydrolysate containing a mix of peptides derived from freshly filleted Norwegian Atlantic salmon using a proprietary mix of non-GMO, nautral peptidase enzymes.

DIETARY_SUPPLEMENT

Microcrystalline Cellulose

Matching placebo tablets consisting of microcrystalline cellulose

Sponsors & Collaborators

  • Alethios, Inc.

    collaborator INDUSTRY

  • Hofseth Biocare ASA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07611305 on ClinicalTrials.gov