ProGo Menopause Wellbeing Study

Official title

A Decentralized, Randomized, Placebo-Controlled Trial Evaluating ProGo® Salmon Protein Hydrolysate Versus Placebo to Improve Body Profile Metrics and Support Overall Wellbeing in Menopausal Women

Overview

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.

Detailed description

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.

Interventions

• Dietary supplement Salmon protein hydrolysate (SPH) powder formulated into a tablet format
  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.
• Dietary supplement Microcrystalline Cellulose
  Matching placebo tablets consisting of microcrystalline cellulose

Primary outcome measures

• Change in body mass index (BMI) [Time frame: 18 weeks]
• Mean change in menopause-specific quality of life (MENQoL) questionnaire total score [Time frame: 18 weeks]

Secondary outcome measures (8)

• Anthropometric measurements [Time frame: 18 weeks]
• Individual domain scores Health-Related Quality of Life [Time frame: 18 weeks]
• Skin health [Time frame: 18 weeks]
• Blood biomarkers [Time frame: 18 weeks]
• Appetite and Hunger Assessment [Time frame: 18 weeks]
• Objective sleep quality [Time frame: 18 weeks]
• Mean calorie intake [Time frame: 18 weeks]
• Daily Activity Assessment [Time frame: 18 weeks]

Eligibility criteria

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:

• 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.
• 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

• 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.

Exclusion criteria

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).

History of cancer (except localized skin cancer without metastases) within 1 year prior to screening.

Significant Comorbid Medical Conditions

• History or presence of clinically significant or uncontrolled cardiovascular, renal, or hepatic disease.
• Active systemic infection (e.g., Lyme disease, tuberculosis, HIV).
• Sleep apnea that is untreated or inadequately controlled.
• Uncontrolled hypothyroidism or hyperthyroidism.
• Active systemic inflammatory or autoimmune disease likely to materially contribute to weight gain through impaired mobility or via treatment with corticosteroid therapy.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Alethios, Inc. — San Francisco

Identifiers

NCT: NCT07611305 · SPH-HBC-006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗