ProGo Menopause Wellbeing Study

NCT07611305 | Not Yet Recruiting

• 1 other identifier: SPH-HBC-006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause Related Conditions

Keywords

Menopause weight gain; Quality of life; Skin health; Sleep quality

Outcome Measures

Primary Outcomes (2)

• Change in body mass index (BMI)

  BMI calculated as weight in kilograms divided by height in meters squared

  18 weeks

• Mean change in menopause-specific quality of life (MENQoL) questionnaire total score

  The MENQOL questionnaire evaluates how menopausal symptoms affect a woman's daily life. It consists of 29 items categorized into four domains: Vasomotor Symptoms (e.g., hot flashes, night sweats) Psychosocial Symptoms (e.g., mood changes, anxiety) Physical Symptoms (e.g., sleep disturbances, fatigue) Sexual Symptoms (e.g., changes in sexual desire or comfort) Participants indicate whether they have experienced each symptom in the past week and rate to what extent each symptom has troubled them on a 7-point Likert scale (0 = not at all bothered; 6 = extremely bothered). The scores for each domain are added together and the total score used to calculate the mean score and the mean score of each domain is added together. The total MENQOL score ranges from 0 (asymptomatic) to 232 (extremely troublesome).

  18 weeks

Secondary Outcomes (8)

• Anthropometric measurements

  18 weeks

• Individual domain scores Health-Related Quality of Life

  18 weeks

• Skin health

  18 weeks

• Blood biomarkers

  18 weeks

• Appetite and Hunger Assessment

  18 weeks

Other Outcomes (2)

• Hot flashes assessment

  18 weeks

• Biomarker-Hot Flash Correlation Analysis

  18 weeks

Study Arms (4)

2.0g per day ProGo

EXPERIMENTAL

ProGo is a salmon protein hydrolysate which will be administered in a tablet format

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

4.0g per day ProGo

EXPERIMENTAL

ProGo is a salmon protein hydrolysate which will be administered in a tablet format

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

Matched placebo 2.0g

PLACEBO COMPARATOR

Placebo tablets containing microcrystalline cellulose

Dietary Supplement: Microcrystalline Cellulose

Matched placebo 4.0g

PLACEBO COMPARATOR

Placebo tablets containing microcrystalline cellulose

Dietary Supplement: Microcrystalline Cellulose

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.

2.0g per day ProGo; 4.0g per day ProGo

Microcrystalline Cellulose DIETARY_SUPPLEMENT

Matching placebo tablets consisting of microcrystalline cellulose

Matched placebo 2.0g; Matched placebo 4.0g

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• Literate in English. Able to understand study instructions and required assessments. Treatment Stability
• Participants must be on stable medical, hormonal, and supplement-based regimens prior to screening and throughout the study period.
• 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
• Able and willing to provide written informed consent prior to participation.
• Willing to comply with all study procedures and protocol requirements.
• Able to swallow tablets. General Health In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.

You may not qualify if:

• Reproductive Stage Cannot Be Reliably Classified:
• 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)
• 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:
• Structured weight-loss programs.
• 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).

Sponsors & Collaborators

• Hofseth Biocare ASA: lead
• Alethios, Inc.: collaborator

Study Sites (1)

Alethios, Inc.

San Francisco, California, 94109, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Zoe Benham

CONTACT

650-206-8006; zoe@alethios.com

Zeenia Framroze

CONTACT

650-206-8006; zeenia@alethios.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)