ProGo for Menopause
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a salmon protein supplement, ProGo® (Salmon protein hydrolysate), can improve body weight and overall quality of life for women experiencing menopause. Participants will take either a ProGo® tablet or a placebo (a pill that looks identical but contains no active ingredient) once daily for 18 weeks. The trial focuses on menopausal women with a Body Mass Index (BMI) between 25 and 32.5, indicating overweight status. Researchers will assess changes in body weight, sleep, skin health, and more. Participants must be in good general health, maintain stable treatment regimens, and not have certain medical conditions or use specific medications. As an unphased trial, this study offers participants the opportunity to contribute to scientific understanding and potentially enhance their health during menopause.
Do I have to stop taking my current medications for the trial?
You need to be on stable medical, hormonal, and supplement-based regimens before and during the study. You cannot start, stop, or change the dose of certain medications, especially those affecting mood, sleep, or menopausal symptoms, within 8 weeks before the trial.
Is there any evidence suggesting that ProGo® is likely to be safe for humans?
Earlier studies have found ProGo®, a product made from salmon protein, to be generally safe for people. Research shows that ProGo® is well-tolerated, with no major side effects reported. Participants have experienced some weight loss, increased energy, and reduced inflammation, suggesting potential benefits.
While specific safety details from these studies aren't provided, testing ProGo® in humans for its effects on weight, energy, and inflammation supports its safety. Its approval for other uses further suggests it is safe for additional clinical testing.12345Why are researchers excited about this trial?
Researchers are excited about ProGo for menopause because it introduces a new active ingredient: salmon protein hydrolysate. Unlike standard treatments, which often include hormone replacement therapies or non-hormonal medications like SSRIs, ProGo is derived from a natural protein source. This makes it appealing to those seeking alternative treatments with potentially fewer side effects. Additionally, its administration in tablet form offers a convenient option for daily use.
What evidence suggests that ProGo® might be an effective treatment for menopause?
Research has shown that ProGo®, a product made from salmon protein, offers promising results for weight management. In earlier studies, participants lost about 6%-7% of their weight, possibly due to increased energy and reduced inflammation. ProGo® is also associated with improved metabolic health, enhancing overall well-being. Some studies suggest that ProGo® may activate certain body functions, contributing to its potential benefits. Overall, these findings indicate that ProGo® could help manage body weight and improve the quality of life for menopausal women. Participants in this trial will receive either 2.0g or 4.0g of ProGo® daily, or a matched placebo, to further evaluate its effectiveness.12456
Are You a Good Fit for This Trial?
This trial is for healthy menopausal women aged 40-65 who are overweight (BMI between 25 and 32.5). Participants should not have major health issues that would prevent them from joining.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ProGo® or placebo daily for 18 weeks to evaluate changes in BMI and menopause-specific quality of life
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ProGo® (Salmon protein hydrolysate)
Trial Overview
The study tests whether ProGo®, a salmon protein supplement, can help with weight management and quality of life in menopausal women compared to a placebo. Participants take either ProGo® or placebo tablets daily for 18 weeks.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
ProGo is a salmon protein hydrolysate which will be administered in a tablet format
ProGo is a salmon protein hydrolysate which will be administered in a tablet format
Placebo tablets containing microcrystalline cellulose
Placebo tablets containing microcrystalline cellulose
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hofseth Biocare ASA
Lead Sponsor
Alethios, Inc.
Industry Sponsor
Citations
NCT07611305 | ProGo Menopause Wellbeing Study
ProGo® peptides have demonstrated moderate weight loss of 6%-7% in prior human studies likely a result of improved energy levels and reduced ...
Investigating the efficacy of 18-week salmon protein ...
Daily supplementation with low-dose SPH improved energy levels, reduced oxidative stress, and modulated inflammatory markers in healthy adults.
(PDF) Investigating the efficacy of 18-week salmon protein ...
Self-reported cosmetic outcomes improved by 23.7% (P = 0.03), with women reporting a 34.5% enhancement in hair, skin, and nail health (P = 0.009) ...
4.
nutraingredients.com
nutraingredients.com/Article/2024/11/11/salmon-derived-peptides-may-activate-glp-1-hofseth-biocare-data/Salmon-derived peptides may activate GLP-1: Hofseth ...
Hofseth BioCare's soluble protein hydrolysate (ProGo), upcycled from Atlantic salmon, may activate the GLP-1 receptor and offer a natural alternative in the ...
Investigating the efficacy of 18-week salmon protein ...
Daily supplementation with low-dose SPH improved energy levels, reduced oxidative stress, and modulated inflammatory markers in healthy adults.
Glucoregulatory Properties of a Protein Hydrolysate ... - PMC
In this study, an investigation into the potential antidiabetic properties of a salmon protein hydrolysate (SPH) was conducted.
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