[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637272":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":60,"collaborators":62,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":32,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":32,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":89,"whyStopped":32,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Hofseth Biocare ASA","INDUSTRY",[8,14,17,23],{"label":9,"type":10,"description":11,"interventionNames":12},"2.0g per day ProGo","EXPERIMENTAL","ProGo is a salmon protein hydrolysate which will be administered in a tablet format",[13],"Dietary Supplement: Salmon protein hydrolysate (SPH) powder formulated into a tablet format",{"label":15,"type":10,"description":11,"interventionNames":16},"4.0g per day ProGo",[13],{"label":18,"type":19,"description":20,"interventionNames":21},"Matched placebo 2.0g","PLACEBO_COMPARATOR","Placebo tablets containing microcrystalline cellulose",[22],"Dietary Supplement: Microcrystalline Cellulose",{"label":24,"type":19,"description":20,"interventionNames":25},"Matched placebo 4.0g",[22],[27,33],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"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.",[9,15],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Microcrystalline Cellulose","Matching placebo tablets consisting of microcrystalline cellulose",[18,24],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Zoe Benham","CONTACT","650-206-8006","zoe@alethios.com",{"name":44,"role":40,"phone":41,"phoneExt":32,"email":45},"Zeenia Framroze","zeenia@alethios.com",[47],{"facility":48,"status":32,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":32},"Alethios, Inc.","San Francisco","California","94109","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-122.41942,37.77493,{"lat":58,"lon":57},{"type":61,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[63],{"name":48,"class":6},"100637272","progo-menopause-wellbeing-study-100637272",false,"NCT07611305","ProGo Menopause Wellbeing Study","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","Inclusion Criteria:\n\nFemale Age 40-65 years (inclusive). Body Mass Index (BMI) between 25.0 and 32.5 kg\u002Fm².\n\nMenopausal Status: participants need to be in the menopausal transition or post-menopause; these are defined as:\n\n1. 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.\n2. Post-menopause: defined as amenorrhea ≥12 consecutive months not attributable to pregnancy, lactation, exogenous hormones, surgery, or other medical causes.\n\nLiterate in English. Able to understand study instructions and required assessments. Treatment Stability\n\n1. Participants must be on stable medical, hormonal, and supplement-based regimens prior to screening and throughout the study period.\n2. Initiation, discontinuation, or dose change within the past 8 weeks of any of the following will be exclusionary:\n\ni. Psychotropic medications known to materially affect fatigue, sleep, or mood, including antidepressants, anxiolytics, sedative-hypnotics, mood stabilizers, or antipsychotic medications.\n\nii. 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.\n\niii. Supplement-based interventions initiated or modified for the purpose of improving sleep, or energy (e.g., adaptogens, sleep aids, energy-enhancing formulations).\n\nc. 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.\n\nInformed Consent and Study Readiness\n\n1. Able and willing to provide written informed consent prior to participation.\n2. Willing to comply with all study procedures and protocol requirements.\n3. Able to swallow tablets. General Health In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.\n\nExclusion Criteria:\n\nReproductive Stage Cannot Be Reliably Classified:\n\n1. 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.\n2. History of hysterectomy, as menstrual bleeding-based staging cannot be applied.\n3. Pregnancy, \\\u003C6 months postpartum, or lactational amenorrhea, or known medical causes of amenorrhea.\n4. History of bilateral oophorectomy (surgical menopause)\n\nAllergy\u002FHypersensitivity:\n\na. Participants with known fish allergy\n\nMajor Psychiatric Conditions likely to be significant factor in weight gain:\n\na. 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.\n\nLocal low-dose vaginal estrogen preparations used for urogenital symptoms (e.g., creams, tablets, or rings) are permitted.\n\nHigh-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\n\nCurrent participation in:\n\n1. Structured weight-loss programs.\n2. New vigorous exercise programs (initiated in last 3 months). Medical Conditions Affecting Menstrual Function\n\na. Clinically diagnosed endocrine disorders known to affect menstruation (e.g., uncontrolled thyroid disease, hyperprolactinemia, polycystic ovary syndrome, unless stable and investigator-approved).\n\nHistory of cancer (except localized skin cancer without metastases) within 1 year prior to screening.\n\nSignificant Comorbid Medical Conditions\n\n1. History or presence of clinically significant or uncontrolled cardiovascular, renal, or hepatic disease.\n2. Active systemic infection (e.g., Lyme disease, tuberculosis, HIV).\n3. Sleep apnea that is untreated or inadequately controlled.\n4. Uncontrolled hypothyroidism or hyperthyroidism.\n5. Active systemic inflammatory or autoimmune disease likely to materially contribute to weight gain through impaired mobility or via treatment with corticosteroid therapy.\n6. Clinically significant anemia or iron deficiency requiring active treatment Impaired Gastrointestinal Absorption\n\nHistory or presence of gastrointestinal disease, surgery, or functional disorder known to impair digestion or absorption of orally administered compounds, including:\n\ni. 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).\n\nSurgery: major surgery within 3 months prior to screening or planned during the study period.\n\nSubstance 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.",true,"FEMALE","40 Years","65 Years",{"count":76,"type":77},100,"ESTIMATED","INTERVENTIONAL",[80],"NA","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.\n\nProGo® 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.\n\nThis 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.\n\nThe trial employs a fully decentralized design to enhance accessibility and support real-world relevance.",[83],"Menopause Related Conditions",[85,86,87,88],"Menopause weight gain","Quality of life","Skin health","Sleep quality","NOT_YET_RECRUITING","2026-05-29",{"date":92,"type":93},"2026-06-02","ACTUAL",{"date":95,"type":77},"2026-06",{"date":97,"type":77},"2027-01",{"name":5,"class":6},1]