Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-25 @ 1:15 PM
Study NCT ID:
NCT06592859
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2024-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quzhou Population Cohort Research Project (Aging Related Research: Intervention of Nicotinamide Mononucleotide in Middle-aged and Elderly People)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-09-09', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'BMI', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Body Mass Index (BMI) is a person\\'s weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.'}, {'measure': 'blood pressure', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Measuring blood pressure at rest.'}, {'measure': 'Changes in the body composition', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Fat mass, muscle mass, visceral fat, water mass determined by Bioelectrical Impedance Analysis (BIA).'}], 'primaryOutcomes': [{'measure': 'blood NAD+ levels', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'NAD+ concentration in serum'}, {'measure': 'SF-36 questionnaire', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Short Form-36 questionnaire is a general health questionnaire consisting of 36 questions. The quality of life among the study participants using questionnaire by comparing with end of study.'}], 'secondaryOutcomes': [{'measure': 'bone density', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Bone density of the lumbar spine will be measured by using dual-energy X-ray absorptiometry.'}, {'measure': 'FVC', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'forced vital capacity will be measured by pulmonary function test.'}, {'measure': 'FEV1', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Forced expiratory volume in one second will be measured by pulmonary function test.'}, {'measure': 'grip strength test', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'One handed grip strength test is used to evaluate physical strength.'}, {'measure': 'flexibility of fingers', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Purdue Pegboard Test is used to test the flexibility and coordination of participants. Participant is required to insert as many pegs as possible into the board in one minute. The number of insertions is considered an indicator of flexibility.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aging', 'NMN'], 'conditions': ['Aging', 'NMN']}, 'descriptionModule': {'briefSummary': 'This study is a single center, randomized, double-blind, placebo-controlled clinical trial of drug intervention on aging. The purpose is to explore the effectiveness of NMN on the premise of ensuring the safety of oral drug, in order to provide effective intervention means for delaying aging and improve the quality of life of the elderly population. The main outcome measures of this study were the efficacy and safety of NMN on aging intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria：\n\n1. Local residents of Quzhou or living in Quzhou for over ten years.\n2. age 40-50 and 60-70 years old, no major bad habits.\n3. Gender unlimited.\n4. in good health and has not undergone major surgery within half a year.\n5. Be able to communicate well with researchers and cooperate with the work during the study.\n6. Written informed consent can be signed voluntarily.\n\nExclusion criteria：\n\n1. Alcoholism, heavy smoking (more than 5 packs/day, 20 cigarettes per pack), drug abuse or substance abuse.\n2. Participants are conducting other clinical trials or using any research drugs or equipment for treatment within 30 days before enrollment (including but not limited to aspirin, metformin, resveratrol, vitamin C, etc.).\n3. Obesity (bmi more than 30).\n4. Pregnant/lactating women.\n5. Disease history:\n\n A) under 60 years old:\n 1. any cancer (erythrocytosis, except basal cell or squamous cell skin cancer).\n 2. coronary artery disease/myocardial infarction/clinically significant congestive heart failure.\n 3. stroke/transient ischemic attack.\n 4. deep vein thrombosis/pulmonary embolism.\n 5. serum creatinine \\> 1.5 mg/dl (male).\n 6. poor control of hypertension (although treated, there is still significant hypertension (systolic blood pressure \\> 160 mmHg, or diastolic blood pressure \\>100 mmHg)).\n 7. history of active liver disease or metabolic acidosis.\n 8. chronic kidney disease/hemodialysis treatment, history of severe kidney damage and/or EGFR ≤ 45ml/min/1.73m2.\n 9. severe autoimmunity/inflammation, such as rheumatoid arthritis, lupus, Crohn\\'s disease, etc.\n 10. nervous system diseases such as dementia, such as Alzheimer/Parkinson\\'s disease.\n 11. diabetes mellitus (hemoglobin \\> 6.5% or fasting blood glucose \\> 126 mg/dL or taking diabetes drugs or insulin treatment).\n 12. recent (within 3 months) cardiovascular events (myocardial infarction, coronary intervention, coronary artery bypass grafting).\n 13. infectious diseases such as HIV, hepatitis, tuberculosis, etc.\n 14. hand or lower limb disability affects normal function and life.\n\n B) older than 60 years:\n 1. any cancer (erythrocytosis, except basal cell or squamous cell skin cancer).\n 2. history of active liver disease or metabolic acidosis.\n 3. chronic kidney disease/hemodialysis treatment, history of severe kidney damage and/or EGFR ≤ 45ml/min/1.73m2.\n 4. severe autoimmunity/inflammation, such as lupus, Crohn\\'s disease, etc.\n 5. nervous system diseases such as dementia, such as Alzheimer/Parkinson\\'s disease.\n 6. recent (within 3 months) cardiovascular events (myocardial infarction, coronary intervention, coronary artery bypass grafting).\n 7. infectious diseases such as HIV, hepatitis, tuberculosis, etc.\n 8. hand or lower limb disability affects normal function and life.\n6. Currently taking the following drugs regularly:\n\n A) chemotherapy drugs (such as tamoxifen, adriamycin, mitoxantrone, bleomycin). B) antiplatelet drugs (e.g., clopidogrel/Plavix, dipyridamole/anglionide, ticlopidine/ticlopidine, except aspirin).\n\n C) cholinesterase inhibitors for Alzheimer\\'s disease (donepezil/alicept).\n7. The researchers believe that the physical factors of the participants may have an adverse impact on the research process or results.'}, 'identificationModule': {'nctId': 'NCT06592859', 'acronym': 'NMNAGING', 'briefTitle': 'Quzhou Population Cohort Research Project (Aging Related Research: Intervention of Nicotinamide Mononucleotide in Middle-aged and Elderly People)', 'organization': {'class': 'OTHER', 'fullName': "People's Hospital of Quzhou"}, 'officialTitle': 'Quzhou Population Cohort Research Project (Aging Related Research: Intervention of Nicotinamide Mononucleotide in Middle-aged and Elderly People)', 'orgStudyIdInfo': {'id': '2023-049'}, 'secondaryIdInfos': [{'id': 'MR-33-24-001563', 'type': 'OTHER', 'domain': 'Medical Research Registration and Filing Information System'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NMN Arm', 'description': 'NMN Arm participants took one capsule (containing 350mg NMN) with breakfast daily for one year.', 'interventionNames': ['Dietary Supplement: NMN']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Placebo arm participants took one capsule (appearance and odor are the same as NMN) with breakfast daily for one year.', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'NMN', 'type': 'DIETARY_SUPPLEMENT', 'description': 'NMN Arm participants took one capsule (containing 350mg NMN or placebo) with breakfast daily for one year.', 'armGroupLabels': ['NMN Arm']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo arm participants took one capsule (appearance and odor are the same as NMN) with breakfast daily for one year.', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '324000', 'city': 'Quzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Beier Jiang', 'role': 'CONTACT', 'email': 'beierjiang@wmu.edu.cn', 'phone': '+86-18367091390'}, {'name': 'Feng Zhang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Guanghui Liu, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Weiqi Zhang, Professor', 'role': 'SUB_INVESTIGATOR'}], 'facility': "People's Hospital of Quzhou", 'geoPoint': {'lat': 28.95944, 'lon': 118.86861}}], 'centralContacts': [{'name': 'Feng Zhang', 'role': 'CONTACT', 'email': 'felix.f.zhang@outlook.com', 'phone': '+86-15657053100'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "People's Hospital of Quzhou", 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Institute of Genomics, Chinese Academy of Sciences', 'class': 'OTHER_GOV'}, {'name': 'Institute of Zoology, Chinese Academy of Sciences', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'researcher', 'investigatorFullName': 'Feng Zhang', 'investigatorAffiliation': "People's Hospital of Quzhou"}}}}