[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hofseth Biocare ASA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Menopause Related Conditions",[30,31,32,33],"Menopause weight gain","Quality of life","Skin health","Sleep quality","NOT_YET_RECRUITING","2026-05-29",{"date":37,"type":38},"2026-06-02","ACTUAL",{"date":40,"type":22},"2026-06",{"date":42,"type":22},"2027-01",{"name":44,"class":45},"Hofseth Biocare ASA","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":56,"maxAge":19,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":67,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":46},"100602141","nt-ii-collagen-for-joint-discomfort-and-function-100602141","NCT07119645","NT-II™ Collagen for Joint Discomfort and Function","A Decentralized, Randomized, Active-Controlled Clinical Trial Investigating the Effects of NT-II™ (Salmon Undenatured Type II Collagen) on Activity-Related Knee Discomfort and Functional Performance in Healthy Adults","NTII-JOINT","Inclusion Criteria:\n\n* Adults aged 20 to 65 years.\n* Self-reported, reproducible knee discomfort associated with any knee-loading activities for at least 3 months prior to screening.\n* Discomfort must occur in at least one knee during a nominated aggravating activity at least twice per week and subside with rest.\n* VAS rating of 30 mm to 75 mm during the past week for the nominated activity.\n* No current diagnosis of structural joint disease (e.g., osteoarthritis).\n* Engages in physical activity involving knee-loading movements at least twice weekly for 20+ minutes.\n* BMI between 20.0 and 32.5 kg\u002Fm².\n* In good general health with no significant medical comorbidities.\n* Able and willing to provide informed consent.\n* Capable of completing study procedures remotely using mobile technology.\n\nExclusion Criteria:\n\n* Persistent knee pain at rest or recent acute lower-limb trauma.\n* Diagnosed structural or inflammatory joint disorders.\n* Current or recent physiotherapy targeting knee pain (within 6 months).\n* Allergy to fish or any study product ingredients.\n* Scheduled lower-limb surgery during the study period.\n* Other musculoskeletal disorders affecting ambulation.\n* Recent joint injections (within 3 months).\n* Use of joint supplements in the past 3 months.\n* Use of analgesics ≥3 days\u002Fweek in the past 3 months.\n* NSAIDs\u002Facetaminophen use is permitted with restrictions:\n* Not within 24 hours of blood sampling or VAS assessments.\n* Must be documented.\n* Chronic use of medications that affect musculoskeletal symptoms (e.g., muscle relaxants, gabapentinoids) unless infrequent (≤2x\u002Fweek) and not within 24 hours of assessments.\n* Regular use of PPIs (\\>3x\u002Fweek in past month).\n* Systemic corticosteroids, immunosuppressants, or opioids within 4 weeks.\n* Unstable weight or significant recent dietary changes.\n* Significant medical conditions (e.g., cancer, hepatic\u002Frenal impairment, CVD, thyroid disease, diabetes).\n* Neurological, cognitive, or psychiatric disorders affecting participation.\n* Use of tobacco\u002Fnicotine or other substances.\n* Diagnosed sleep disorders.\n* Strict vegan diet or sedentary lifestyle.\n* Inability to swallow capsules.\n* Pregnant, breastfeeding, or planning pregnancy.\n* Women of childbearing potential not using contraception.\n* Participation in another interventional clinical trial.","ALL","20 Years",{"count":58,"type":22},120,[25],"The goal of this clinical trial is to learn whether a natural marine supplement called NT-II™ (Salmon Undenatured Type II Collagen) can help lower knee discomfort caused by physical activity in otherwise healthy adults. Many active people experience knee pain when performing daily movements like climbing stairs, walking long distances, or squatting, even if they do not have a medical diagnosis such as arthritis. This discomfort can limit mobility, impact exercise routines, and reduce overall quality of life. This study is being conducted to determine whether NT-II™, taken as a once-daily oral supplement, can reduce this type of activity-related knee discomfort more effectively than a commonly used joint supplement containing glucosamine and chondroitin.\n\nThe main questions the study aims to answer are:\n\nDoes NT-II™ reduce knee discomfort caused by repeated activity over a 12-week period?\n\nDoes NT-II™ improve movement and quality of life compared to glucosamine-chondroitin?\n\nResearchers will compare two different doses of NT-II™ (240 mg and 480 mg) to glucosamine (1500 mg) plus chondroitin (1300 mg), which is used as an active comparator. All three products will be taken once daily for 12 weeks.\n\nParticipants will:\n\nTake their assigned supplement daily by mouth for 12 weeks\n\nTrack knee discomfort once per week using a pain rating scale called a visual analog scale (VAS) while doing an activity that usually causes discomfort, such as climbing stairs, walking, or squatting\n\nComplete short surveys online about joint function, pain, and quality of life (including KOOS and SF-12 questionnaires)\n\nUse a mobile app to perform simple knee range of motion tests at home\n\nWear a fitness tracker to monitor daily physical activity, such as step count and stair climbing\n\nCollect two small blood samples at home using a finger-prick kit to check for changes in inflammation-related biomarkers\n\nThis study is for U.S.-based adults between the ages of 20 and 65 who are in generally good health but have had mild to moderate knee discomfort caused by physical activity for at least three months. The pain must be triggered by specific weight-bearing movements and be relieved by rest. Participants must not have osteoarthritis, rheumatoid arthritis, or other joint diseases. Individuals with recent knee injuries, major surgeries, or injections in the past six months cannot take part. Participants should not be using NSAIDs, turmeric, collagen, or other joint-related supplements during the study.\n\nAll study activities will take place remotely using a secure digital platform. There are no in-person clinic visits required. Eligible participants will receive all study materials by mail, including supplements, a wearable device, and an at-home blood sample collection kit. They will also be given access to a secure digital platform (Alethios) where they can complete questionnaires, enter pain ratings, and receive study instructions. Study staff will monitor progress, check for missing data, and assist participants through secure communication tools built into the platform.\n\nThe primary outcome of the study is the change in participant-reported knee discomfort, measured using a nominated activity VAS score (VASNA), from baseline to week 12. Additional outcomes will explore changes in function, mobility, physical activity, heart rate variability, and inflammatory biomarkers. The Pain Catastrophizing Scale (PCS) will also be used to examine whether thoughts and feelings about pain influence symptom reporting and treatment response.\n\nThis trial is sponsored by Hofseth BioCare ASA and is being conducted entirely online to improve access, lower participant burden, and support real-world understanding of joint health supplements. Study results may inform the use of NT-II™ as a marine-based nutritional strategy to support joint comfort in active individuals.",[62,63,64,65,66],"Activity-Related Knee Discomfort","Joint Discomfort","Functional Joint Pain","Functional Knee Pain","Knee Acute and Chronic Pain",[68,69,70,71,72,73,74,75,76,77,78,79],"Undenatured Type II Collagen","NT-II™","Salmon Collagen","Glucosamine","Chondroitin","Joint Health","Knee Pain","Range of Motion","Activity-Related Pain","Inflammation","Decentralized Clinical Trial","Activity-related Knee Discomfort","RECRUITING","2026-05-12",{"date":83,"type":38},"2026-05-14",{"date":85,"type":38},"2025-01-20",{"date":87,"type":22},"2026-10-15",{"name":44,"class":45},""]