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Salmon protein may ease menopause symptoms and help weight

NCT ID NCT07611305

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether a daily supplement made from salmon protein (ProGo®) can help menopausal women manage their weight and improve quality of life. About 100 healthy, overweight women aged 40-65 will take either a low or high dose of ProGo® or a placebo for 18 weeks. Researchers will track changes in BMI and menopause-related symptoms like hot flashes, mood, and sleep.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Salmon protein hydrolysate (ProGo®)
What this could lead to
If it works, this could offer a natural supplement to help menopausal women manage weight and improve daily well-being.
What could go wrong
This is an early-stage trial with only 100 participants, so results may not apply to everyone. The supplement may not outperform placebo, and weight loss seen in prior studies was modest.
Why investors are watching

Hofseth Biocare is testing ProGo, a salmon protein supplement, in 100 menopausal women to see if it lowers BMI and improves quality of life. For a micro-cap company, this readout matters because ProGo is a core product, and a positive result could support its commercial claims and future sales.

If it works: If the trial shows ProGo helps with weight and menopause symptoms, the company could use that data to market the supplement more strongly to consumers and retailers. That could boost revenue for a small firm.

If it fails: Trials often fail to show a clear benefit, and this one has only 100 participants, so results may be weak or inconclusive. A negative or muddy outcome could hurt the product's credibility and the company's growth plans.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 65 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Female Age 40-65 years (inclusive). Body Mass Index (BMI) between 25.0 and 32.5 kg/m². Menopausal Status: participants need to be in the menopausal transition or post-menopause; these are defined as: 1. 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. 2. Post-menopause: defined as amenorrhea ≥12 consecutive months not attributable to pregnancy, lactation, exogenous hormones, surgery, or other medical causes. Literate in English. Able to understand study instructions and required assessments. Treatment Stability 1. Participants must be on stable medical, hormonal, and supplement-based regimens prior to screening and throughout the study period. 2. Initiation, discontinuation, or dose change within the past 8 weeks of any of the following will be exclusionary: i. Psychotropic medications known to materially affect fatigue, sleep, or mood, including antidepressants, anxiolytics, sedative-hypnotics, mood stabilizers, or antipsychotic medications. ii. Therapies specifically intended to treat menopausal symptoms (other than those explicitly permitted), including non-systemic hormonal agents, compounded hormone preparations, or pharmacologic agents prescribed for menopausal symptom relief. iii. Supplement-based interventions initiated or modified for the purpose of improving sleep, or energy (e.g., adaptogens, sleep aids, energy-enhancing formulations). c. Participants must agree to maintain stable use of all permitted medications and supplements and not initiate new treatments likely to affect sleep, mood, or energy during the study period. Informed Consent and Study Readiness 1. Able and willing to provide written informed consent prior to participation. 2. Willing to comply with all study procedures and protocol requirements. 3. Able to swallow tablets. General Health In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product. Exclusion Criteria: Reproductive Stage Cannot Be Reliably Classified: 1. 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. 2. History of hysterectomy, as menstrual bleeding-based staging cannot be applied. 3. Pregnancy, \<6 months postpartum, or lactational amenorrhea, or known medical causes of amenorrhea. 4. History of bilateral oophorectomy (surgical menopause) Allergy/Hypersensitivity: a. Participants with known fish allergy Major Psychiatric Conditions likely to be significant factor in weight gain: a. Recent antidepressant or anti-psychotic initiation or dose change. Current or recent use (last 3-6 months) of systemic hormone replacement therapy (HRT), selective estrogen receptor modulators (SERMs), or other pharmacologic therapies intended to treat menopausal symptoms. Local low-dose vaginal estrogen preparations used for urogenital symptoms (e.g., creams, tablets, or rings) are permitted. High-dose iron supplements or IV iron. Sleep medications Strong herbal or phytoestrogen supplements (soy, red clover, etc.). Use of protein hydrolysate supplements. Vegan or vegetarian Current participation in: 1. Structured weight-loss programs. 2. New vigorous exercise programs (initiated in last 3 months). Medical Conditions Affecting Menstrual Function a. Clinically diagnosed endocrine disorders known to affect menstruation (e.g., uncontrolled thyroid disease, hyperprolactinemia, polycystic ovary syndrome, unless stable and investigator-approved). History of cancer (except localized skin cancer without metastases) within 1 year prior to screening. Significant Comorbid Medical Conditions 1. History or presence of clinically significant or uncontrolled cardiovascular, renal, or hepatic disease. 2. Active systemic infection (e.g., Lyme disease, tuberculosis, HIV). 3. Sleep apnea that is untreated or inadequately controlled. 4. Uncontrolled hypothyroidism or hyperthyroidism. 5. Active systemic inflammatory or autoimmune disease likely to materially contribute to weight gain through impaired mobility or via treatment with corticosteroid therapy. 6. Clinically significant anemia or iron deficiency requiring active treatment Impaired Gastrointestinal Absorption History or presence of gastrointestinal disease, surgery, or functional disorder known to impair digestion or absorption of orally administered compounds, including: i. Celiac disease ii. Short bowel syndrome or malabsorption syndromes iii. Chronic pancreatitis or exocrine pancreatic insufficiency iv. Prior bariatric or gastric surgery b. Inflammatory bowel disease (Crohn's disease or ulcerative colitis) requiring ongoing systemic therapy (including steroid, immunomodulatory, or monoclonal antibody therapy). Surgery: major surgery within 3 months prior to screening or planned during the study period. Substance Use History History of clinically significant alcohol or substance use disorder within the past three years, or alcohol intake significantly above accepted public health thresholds.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alethios, Inc.

    San Francisco, California, 94109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.