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
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
Treatments tested in this trial
- Salmon protein hydrolysate (SPH) powder formulated into a tablet format
- Microcrystalline Cellulose
Treatment groups
100 Participants
are divided into 4 treatment groupsSponsors and collaborators
Hofseth Biocare ASA
Lead sponsor
Alethios, Inc.
Collaborator
Source ClinicalTrials.gov