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.
The menopause transition (MT) is the phase leading up to menopause. Menopause is defined as 12 consecutive months without menstruation in the absence of other causes and marks the end of reproductive function, with the final menstrual period (FMP) reflecting cessation of ovarian follicular activity. The menopause is variable in its onset, overall length, severity of symptoms, and impact on functioning, and irregular ovulation and fluctuating estrogen and progesterone levels, gives rise to a broad spectrum of symptoms including hot flashes, night sweats, weight gain and musculoskeletal pain. Women commonly experience a broader symptom burden, averaging 7 to 10 concurrent symptoms across psychological, cognitive, pain, and sleep domains which can substantially impair quality of life and comprise a substantial proportion of the menopausal symptom burden. ProGo®, a salmon protein hydrolysate, has demonstrated benefits relevant to the menopause and healthy ageing. ProGo® is produced through controlled enzymatic processing and consists predominantly of water-soluble peptides with an average size of 2,500-3,000 Daltons, supporting rapid digestion and systemic availability. In addition to its protein content, ProGo® contains naturally occurring micronutrients and collagen-derived peptides that may support metabolic and cellular energy demands. Across human and preclinical studies, ProGo® has demonstrated moderate reductions in body mass index (BMI) of ca.6% in two trials of healthy, overweight subjects. Improved energy levels may in part explain the positive BMI outturn. The studies also showed a reduction in inflammation and improved fat metabolism which might also have contributed to the observed weight loss. The comparator in these studies, whey protein, was either weight neutral or resulted in a small amount of weight gain (ca.1.5%). It should be noted that the studies were of 6-8 weeks duration and therefore persistence of the BMI reduction has not been fully elucidated. Nevertheless an 18-week study of ProGo® supplementation at 4.0g per day showed very similar antioxidant effects as well as on metabolic health biomarkers along with improvements in self-reported energy and fatigue-related symptoms. Together, these findings support the biological plausibility of ProGo® as a nutritional intervention to support health during midlife and beyond such as during the menopause. Accordingly, this study is designed to evaluate the effect of ProGo® supplementation on BMI and quality of life as co-primary outcomes in menopausal women. Specifically, this randomized, placebo-controlled trial will evaluate two daily doses of ProGo® (2.0 g and 4.0 g) compared with placebo in otherwise healthy menopausal women who are overweight. As noted above, 4.0g per day provided a similar magnitude of changes in biomarkers related to energy and wellbeing as higher daily serving sizes (12.0g and 16.0g) employed in previous studies. In vitro work has indicated that 2.0g per day could provide similar health benefits as 4.0g per day which would also increase convenience of taking ProGo®, whether as a powder of tablets. Hence the selection of the 2.0g per day and 4.0g per day for this study. A fully decentralized study design is employed to enhance accessibility and real-world relevance while supporting frequent symptom assessment. The co-primary outcomes are change in BMI (kg/m²), assessed weekly via standardized self-measurement, and change in menopause-specific quality of life, assessed using the menopause-specific quality of life (MENQoL) questionnaire at baseline, Week 9, and Week 18. Secondary outcomes include anthropometric measures, skin health assessment via standardized photography, vasomotor symptom severity, appetite, wearable-derived activity and sleep metrics, and dried blood spot biomarkers to provide mechanistic context. The trial aims to characterize the magnitude and trajectory of BMI and quality-of-life change, explore dose-response relationships, and inform the role of ProGo® as a nutritional strategy for addressing weight gain and symptom burden during the menopausal transition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
100
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.
Matching placebo tablets consisting of microcrystalline cellulose
Alethios, Inc.
San Francisco, California, United States
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
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
Appetite and Hunger Assessment
Mean change in participant-rated appetite and hunger assessed using a 0-100 visual analogue score (VAS) with (0) representing fully satisfied / no hunger and 100 the hungriest imaginable.
Time frame: 18 weeks
Objective sleep quality
Wearable-Derived Sleep Metrics. Mean change in sleep quality, measured as number of awakenings per night and sleep efficiency.
Time frame: 18 weeks
Mean calorie intake
App-based calorie estimation: trend analysis of change in mean calorie intake
Time frame: 18 weeks
Daily Activity Assessment
Wearable-Derived Activity \& Health Metrics. Mean change in daily step count, floors climbed and heart rate variability (HRV) assessed continuously via wearable devices.
Time frame: 18 weeks
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