Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-29 @ 8:08 PM
Study NCT ID:
NCT03348566
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2017-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fish and Marine Fatty Acids, Genetic Signatures of Diet Adaptation, and Long-term Weight Changes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017404', 'term': 'In Situ Hybridization, Fluorescence'}], 'ancestors': [{'id': 'D017403', 'term': 'In Situ Hybridization'}, {'id': 'D013194', 'term': 'Staining and Labeling'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D020732', 'term': 'Cytogenetic Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D009693', 'term': 'Nucleic Acid Hybridization'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2017-10-26', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight changes', 'timeFrame': '6-10 years', 'description': 'long term weight changes: this study measured body weight at baseline (1990) and follow up body weight in 2000. The long term body weight was defined as changes from baseline to follow up endpoint'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '28387720', 'type': 'BACKGROUND', 'citation': 'Heianza Y, Qi L. Gene-Diet Interaction and Precision Nutrition in Obesity. Int J Mol Sci. 2017 Apr 7;18(4):787. doi: 10.3390/ijms18040787.'}, {'pmid': '24646652', 'type': 'BACKGROUND', 'citation': 'Qi Q, Chu AY, Kang JH, Huang J, Rose LM, Jensen MK, Liang L, Curhan GC, Pasquale LR, Wiggs JL, De Vivo I, Chan AT, Choi HK, Tamimi RM, Ridker PM, Hunter DJ, Willett WC, Rimm EB, Chasman DI, Hu FB, Qi L. Fried food consumption, genetic risk, and body mass index: gene-diet interaction analysis in three US cohort studies. BMJ. 2014 Mar 19;348:g1610. doi: 10.1136/bmj.g1610.'}]}, 'descriptionModule': {'briefSummary': 'the investigators tested whether genetic variants near FADS cluster, which were recently identified to be signatures of adaptation to fish- and n-3 PUFAs-rich diet, interacted with these dietary factors on long-term change of body mass index (BMI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The Nurses' Health Study began in 1976, when 121,700 female registered nurses aged 30-55 y were recruited to complete a baseline questionnaire. the investigators included 11,323 women of European ancestry. Informed consent was obtained from all participants.\n\nThe Health Professionals Follow-up Study The HPFS was initiated in 1986, and was composed of 51,529 male aged 40-75 y at baseline. This study included 6,833 men whose genotype data were available. Informed consent was obtained from all participants.\n\nThe Women's Health Initiative (WHI) is a large, multiethnic, 40-center study that focuses on strategies for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women. 6,254 Caucasians women with European ancestry were included.\n\nThe design of Singapore Chinese Health Study (SCHS): Between 1993 and 1998, 63,257 Chinese between 45 and 74 in Singapore were enrolled. 5,264 subjects with genotyping data were included in this analysis.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 11,323 women of European ancestry.\n* Informed consent was obtained from all participants. The DNA extraction methods, quality control measures,\n* SNPs genotyping and imputation data are available .\n* Both cases and controls with genotyping data are available based on GWASs\n\nExclusion Criteria:\n\n* participants without genetic data'}, 'identificationModule': {'nctId': 'NCT03348566', 'briefTitle': 'Fish and Marine Fatty Acids, Genetic Signatures of Diet Adaptation, and Long-term Weight Changes', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Fish and Marine Fatty Acids, Genetic Signatures of Diet Adaptation, and Long-term Weight Change', 'orgStudyIdInfo': {'id': 'NHS25487541'}}, 'armsInterventionsModule': {'interventions': [{'name': 'fish', 'type': 'OTHER', 'description': 'fish intkae'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data belongs to HSPH'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}