Menopause Related ConditionsNCT07611305
ProGo Menopause Wellbeing Study
A study testing Salmon protein hydrolysate (SPH) powder formulated into a tablet format and Microcrystalline Cellulose in people with Menopause Related Conditions, run by Hofseth Biocare ASA at 1 site in United States.
Trial 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®… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause Related Conditions
- What is being tested?
- Salmon protein hydrolysate (SPH) powder formulated into a tablet format and Microcrystalline Cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- Initiation, discontinuation, or dose change within the past 8 weeks of any of the following will be exclusionary:
- Psychotropic medications known to materially affect fatigue, sleep, or mood, including antidepressants, anxiolytics, sedative-hypnotics, mood stabilizers, or antipsychotic medications.
- 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.
- Supplement-based interventions initiated or modified for the purpose of improving sleep, or energy (e.g., adaptogens, sleep aids, energy-enhancing formulations).
- 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.
Who cannot join
- 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:
Show all 27Show fewer
- Participants with known fish allergy
- Major Psychiatric Conditions likely to be significant factor in weight gain:
- 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
- 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:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this 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
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.
Read more
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.
Read the 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.
- Conditions
- Menopause Related Conditions
- Being tested
- Salmon protein hydrolysate (SPH) powder formulated into a tablet format, Microcrystalline Cellulose
- Keywords
- Menopause weight gain, Quality of life, Skin health, Sleep quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmon protein hydrolysate (SPH) powder formulated into a tablet formatDietary 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 CelluloseDietary supplement
Matching placebo tablets consisting of microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| 2.0g per day ProGo | Experimental | ProGo is a salmon protein hydrolysate which will be administered in a tablet format Receives: 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 Receives: Dietary Supplement: Salmon protein hydrolysate (SPH) powder formulated into a tablet format |
| Matched placebo 2.0g | Placebo comparator | Placebo tablets containing microcrystalline cellulose Receives: Dietary Supplement: Microcrystalline Cellulose |
| Matched placebo 4.0g | Placebo comparator | Placebo tablets containing microcrystalline cellulose Receives: Dietary Supplement: Microcrystalline Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index (BMI)
BMI calculated as weight in kilograms divided by height in meters squared
Measured: 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).
Measured: 18 weeks
Secondary outcomes (8)
Anthropometric measurements
Change in standardized waist \& hip circumference (cm) self- measurements, assessed every 6 weeks, from baseline
Measured: 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
Measured: 18 weeks
Skin health
Change in facial fine lines and wrinkles by app-based assessment of standardised photographs
Measured: 18 weeks
Blood biomarkers
To measure gut health, iron balance, glucose metabolism and inflammatory balance
Measured: 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.
Measured: 18 weeks
Objective sleep quality
Wearable-Derived Sleep Metrics. Mean change in sleep quality, measured as number of awakenings per night and sleep efficiency.
Measured: 18 weeks
Mean calorie intake
App-based calorie estimation: trend analysis of change in mean calorie intake
Measured: 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.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause Related ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hofseth Biocare ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611305
- Sponsor's protocol ID
- SPH-HBC-006
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will put the anonymized data from the study onto the Figshare platform so that journal reviewers and editors can review it as well as other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07611305
- Acronym / sponsor ID
- SPH-HBC-006
- Conditions
- Menopause Related Conditions
- Keywords
- Menopause weight gain, Quality of life, Skin health, Sleep quality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hofseth Biocare ASAIndustry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2.0g per day ProGo | Experimental | Dietary Supplement: Salmon protein hydrolysate (SPH) powder formulated into a tablet formatProGo is a salmon protein hydrolysate which will be administered in a tablet format |
| 4.0g per day ProGo | Experimental | Dietary Supplement: Salmon protein hydrolysate (SPH) powder formulated into a tablet formatProGo is a salmon protein hydrolysate which will be administered in a tablet format |
| Matched placebo 2.0g | Placebo comparator | Dietary Supplement: Microcrystalline CellulosePlacebo tablets containing microcrystalline cellulose |
| Matched placebo 4.0g | Placebo comparator | Dietary Supplement: Microcrystalline CellulosePlacebo tablets containing microcrystalline cellulose |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (27 listed)
- 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)
- Participants with known fish allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salmon protein hydrolysate (SPH) powder formulated into a tablet formatSalmon 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 | 2.0g per day ProGo, 4.0g per day ProGo |
| Microcrystalline CelluloseMatching placebo tablets consisting of microcrystalline cellulose | Dietary supplement | Matched placebo 2.0g, Matched placebo 4.0g |
Primary outcome
Change in body mass index (BMI)
Time frame: 18 weeks
BMI calculated as weight in kilograms divided by height in meters squared
Mean change in menopause-specific quality of life (MENQoL) questionnaire total score
Time frame: 18 weeks
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).
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. We will put the anonymized data from the study onto the Figshare platform so that journal reviewers and editors can review it as well as other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salmon protein hydrolysate (SPH) powder formulated into a tablet format and Microcrystalline Cellulose in people with Menopause Related Conditions, run by Hofseth Biocare ASA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe Benham (650-206-8006, zoe@alethios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index (BMI) (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.