Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-04 @ 7:25 AM
Study NCT ID:
NCT05282992
Status:
COMPLETED
Last Update Posted:
2024-08-29
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NAtive Collagen Type II In Healthy VoluntEers With Joint Discomfort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018771', 'term': 'Arthralgia'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2022-02-23', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Daily activity levels', 'timeFrame': 'Day 0 to 180, anytime', 'description': 'A fitness tracker will monitor the steps taken daily'}, {'measure': 'Muscle quality', 'timeFrame': 'Day 0 and 180', 'description': 'Muscle quality will be evaluated by an ultrasound index'}, {'measure': 'Safety assessment', 'timeFrame': 'Day 0 to 180, anytime', 'description': 'Adverse events'}, {'measure': 'Safety assessment', 'timeFrame': 'Day 0 to day 60, 90, 120, 180', 'description': 'Medical exams (weight in kilograms, height in meters, BMI in kg/m\\^2)'}, {'measure': 'Safety assessment', 'timeFrame': 'Day 0 to day 60, 90, 120, 180', 'description': 'Vital signs (heart rate in bpm and blood pressure mmHg)'}, {'measure': 'Safety assessment', 'timeFrame': 'Day 0 and 180', 'description': 'Laboratory analysis (total blood count, glucose, AST, ALT, Cholesterol, Creatinine, BUN, triglycerides, alkaline phosphatase)'}], 'primaryOutcomes': [{'measure': 'Change in joint discomfort onset', 'timeFrame': 'Change in joint discomfort onset at 6 months', 'description': 'Determine differences from baseline on reaching a joint pain of 5/1 while going up and down stairs (max 10 min).'}], 'secondaryOutcomes': [{'measure': 'Joint discomfort', 'timeFrame': 'Day 0 to day 60, 90, 120, 180', 'description': 'Visual Analog Scale (VAS, 0-10cm) pain at rest and during activity. A higher VAS means higher pain levels'}, {'measure': 'Joint function', 'timeFrame': 'Day 0 to day 60, 90, 120, 180', 'description': 'Knee injury and Osteoarthritis Outcome Score (KOOS) test'}, {'measure': 'Time to Joint discomfort', 'timeFrame': 'Day 0 to day 60, 90, 120, 180', 'description': 'Time to joint discomfort and to recover from pain in 3 different exercises'}, {'measure': '6 minute walking timed test (6MWT)', 'timeFrame': 'Day 0 and 180', 'description': 'Distance a person is capable of walking on a flat, hard surface in 6 minutes'}, {'measure': 'Rescue medication consumption', 'timeFrame': 'Day 0 to 180, anytime', 'description': 'Rescue medication: Paracetamol 500mg. max 2 pills/day'}, {'measure': 'Cartilage turnover biomarkers', 'timeFrame': 'Day 0 and 180', 'description': 'Cartilage turnover biomarkers will be measured in blood and urine (CTX-II, C2C, CPII)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Joint Pain']}, 'descriptionModule': {'briefSummary': 'Collagen Supplement is a natural ingredient that contains native collagen derived from chicken sternum. Collagen Supplement is efficacious and safe on healthy subjects as compared to placebo.', 'detailedDescription': 'This study will include 100 healthy volunteers in which will be evaluated if the collagen supplement is able to obtain differences versus placebo in pain and function. It will be a randomized, double-blind, placebo-controlled study with proportion 1:1 between treatments'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and non-pregnant females 30-65 years old with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2. (see Section 4.0)\n* Unilateral or bilateral knee discomfort for greater than 3 months.\n* VAS score during knee movement between 30-50 mm after 7-day withdrawal of excluded medications.\n* Reach joint discomfort of 5/10 on a 11-point Likert scale ( score 0 to 10) within 10 minutes of going up and down stairs.\n* Clinical laboratory results that are within normal range or considered not clinically significant by the Principal Investigator.\n* Be willing to participate in all scheduled visits, tests, and other trial procedures according to the clinical protocol. To do so and be able of using the fitness tracker, a phone or tablet compatible with the Fitbit app is required. (Apple iOS 12.2 or higher, Android OS 7.0 or higher.)\n* Be willing to refrain from taking ibuprofen, aspirin or other Non-steroidal anti-inflammatory drugs (NSAIDs), or any other pain reliever (OTC (Over the Counter) or prescription) during the entire study other than acetaminophen (paracetamol) as rescue medication.\n* Provide a signed and dated informed consent indicating that the subject has been informed of all pertinent aspects and possible risks associated with participation in the study.\n* Be willing to refrain from taking dietary supplements during the entire study that have any underlying joint benefit (collagen, glucosamine, chondroitin, MSM, Hyaluronic Acid, Turmeric, Natural Eggshell Membrane, Omega-3 fatty acids, PEA, Boswellia,…)\n\nExclusion Criteria:\n\n* History of hypersensitivity to the rescue medication or any of the products used in the study.\n* Requirement of drugs to control joint discomfort.\n* Regular drug intake to control any kind of pain.\n* History of hypersensitivity to eggs, chicken, or fowl.\n* History of Knee OA (OsteoArthritis), inflammatory arthropathy, RA (Rheumatoid Arthritis), OA (VAS score greater than 50), or Systemic Lupus Erythematosus.\n* Hyperuricemia (\\>440 μmol/L), history of gout, or both.\n* Exercising (intentionally) for more than 10 hours a week\n* High intensity exercise for more than 5 hours a week\n* Anticipation of surgery within the next 6 months.\n* Recent injury in the target knee (past 4 months).\n* History of congestive heart failure.\n* Anticipated problems with product consumption.\n* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies within the last 5 years.\n* High alcohol intake (\\>2 standard drinks per day) or use of recreational drugs (e.g., cocaine, methamphetamine, marijuana, etc.).\n* Females who are pregnant or lactating or planning to become pregnant.\n* History of any mental illness that might impair the ability of subjects to provide a written informed consent.\n* Use of oral corticosteroid, indomethacin, SYSADOAs (symptomatic slow action drug osteoarthritis) within 3 months of Visit 1; topical treatment with corticosteroids within 1 week of visit 1, and consumption of Omega 3 fatty acids or any other joint health dietary supplements within 2 weeks preceding the treatment period.\n* Consumed, ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription), or any natural health product, (excluding vitamins) within 7 days of first visit.\n* Consumed acetaminophen (paracetamol) within 48 hours of randomization visit.\n* Participation in any clinical trials within 30 days prior to first visit.\n* Individuals following an energy restricted diet for weight loss'}, 'identificationModule': {'nctId': 'NCT05282992', 'acronym': 'ACTIVE', 'briefTitle': 'NAtive Collagen Type II In Healthy VoluntEers With Joint Discomfort', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioiberica'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Tolerability of a Food Supplement in Healthy Volunteers With Joint Discomfort', 'orgStudyIdInfo': {'id': 'PJ-00081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Native type II collagen', 'description': 'Native type II collagen', 'interventionNames': ['Dietary Supplement: Native type II collagen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Native type II collagen', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 capsule/day', 'armGroupLabels': ['Native type II collagen']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 capsule/day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Instituto Poal de Reumatología', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioiberica', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}