ProGo Menopause Wellbeing Study

ConditionMenopause Related Conditions

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age40-65

SponsorHofseth Biocare ASA

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Able and willing to provide written informed consent prior to participation.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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.
Microcrystalline Cellulose
Dietary supplement
Matching placebo tablets consisting of microcrystalline cellulose

Treatment groups

100 Participants

are divided into 4 treatment groups

Group A: 2.0g per day ProGoExperimental treatment 1 intervention

Group B: 4.0g per day ProGoExperimental treatment 1 intervention

Group C: Matched placebo 2.0gPlacebo comparator 1 intervention

Group D: Matched placebo 4.0gPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in body mass index (BMI)

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

Time frame

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).

Time frame

18 weeks

Secondary outcomes

Anthropometric measurements

Change in standardized waist \& hip circumference (cm) self- measurements, assessed every 6 weeks, from baseline

Time frame

18 weeks

Individual domain scores Health-Related Quality of Life

Mean change in Menopause-specific Quality of Life (MENQOL) domain scores comprising Vasomotor, Psychosocial, Physical, Sexual

Time frame

18 weeks

Skin health

Change in facial fine lines and wrinkles by app-based assessment of standardised photographs

Time frame

18 weeks

Blood biomarkers

To measure gut health, iron balance, glucose metabolism and inflammatory balance

Time frame

18 weeks

Other outcomes

Hot flashes assessment

Hot Flash visual analogue scale (VAS) score with scores ranging from 0 (no hot flashes) to 100 (worst possible hot flashes severity) to assess the mean change in participant-rated hot flash severity

Time frame

18 weeks

Biomarker-Hot Flash Correlation Analysis

Exploratory analyses assessing correlations between change in VAS hot flash score and change in blood biomarkers

Time frame

18 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hofseth Biocare ASA

Lead sponsor

Alethios, Inc.

Collaborator

Source ClinicalTrials.gov

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