ProGo Menopause Wellbeing Study (NCT07611305) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ProGo Menopause Wellbeing Study
United States100 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
40 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Menopausal transition: defined by persistent menstrual cycle length variability, without a history of ≥12 consecutive months of amenorrhea (i.e., post-menopause not yet reached). Any menstrual bleeding must be spontaneous and not induced by exogenous hormones.
. Post-menopause: defined as amenorrhea ≥12 consecutive months not attributable to pregnancy, lactation, exogenous hormones, surgery, or other medical causes.
. Participants must be on stable medical, hormonal, and supplement-based regimens prior to screening and throughout the study period.
Exclusion criteria
. Able and willing to provide written informed consent prior to participation.
. Willing to comply with all study procedures and protocol requirements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in body mass index (BMI)
Timeframe: 18 weeks
2
Mean change in menopause-specific quality of life (MENQoL) questionnaire total score
. Able to swallow tablets. General Health In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
. Use, within the preceding 3 months of systemic hormonal therapies that alter menstrual bleeding patterns, including systemic hormonal contraception, hormone replacement therapy (HRT), or GnRH analogs.
. History of hysterectomy, as menstrual bleeding-based staging cannot be applied.
. Pregnancy, \<6 months postpartum, or lactational amenorrhea, or known medical causes of amenorrhea.
. History of bilateral oophorectomy (surgical menopause)