Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-12 @ 6:53 AM
Study NCT ID:
NCT04125602
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2019-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Westlake N-of-1 Trials for Macronutrient Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-03', 'studyFirstSubmitDate': '2019-10-10', 'studyFirstSubmitQcDate': '2019-10-11', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fecal metabolites', 'timeFrame': 'Day 1, day7, day 13 and day 19 of each set', 'description': 'Fecal metabolite extracts will be analysed by performing liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS).'}, {'measure': 'Fecal microbiota', 'timeFrame': 'Day 1, day7, day 13 and day 19 of each set', 'description': 'Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.'}, {'measure': 'Metabolomics profiling', 'timeFrame': 'Day 1, day7, day 13 and day 19 of each set', 'description': 'Targeted metabonomics are analyzed based on urine and faeces at all visits (also based on serum in set 1).'}, {'measure': 'Laboratory markers of glucose metabolism and inflammation', 'timeFrame': 'Day 1, day7, day 13 and day 19 of set 1', 'description': 'insulin, leptin, adiponection, free fatty acid, Interleukin(IL)-6, IL-8, IL-10, IL-12, IL-17A, IL-1ra, tumour necrosis factor alpha (TNF-α), Lipopolysaccharide binding protein (LBP), cortisol, high-sensitivity C-reactive protein, serum amyloid A, soluble E-selectine, soluble intracellular adhesion molecule-1, plasminogen activator inhibitor-1, vascular cell adhesion molecule, monocyte chemoattractant protein (MCP)-1, adrenaline, noradrenaline, peptide YY, and neuropeptide Y are tested at all visits of set 1.'}, {'measure': 'Lipid metabolism', 'timeFrame': 'Day 1, day7, day 13 and day 19 of set 1', 'description': 'Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B are tested at all visits of set 1.'}, {'measure': 'Physiological characteristics', 'timeFrame': 'Day 1, day7, day 13 and day 19 of set 3', 'description': 'Weight and blood pressure are collected at all visits of set 3.'}], 'primaryOutcomes': [{'measure': 'Postprandial blood glucose change', 'timeFrame': 'Day 7-12 and day 19-24 of each set', 'description': 'Postprandial blood glucose from different foods will be assessed.'}, {'measure': 'Blood glucose profiling', 'timeFrame': 'Day 7-12 and day 19-24 of each set', 'description': 'Glucose levels will be recorded by continuous glucose monitoring over the intervention periods.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Personalized Nutrition', 'Glucose Metabolism', 'Gut Microbiota'], 'conditions': ['Postprandial Hyperglycemia', 'Metabolic Disorder, Glucose']}, 'referencesModule': {'references': [{'pmid': '32968703', 'type': 'DERIVED', 'citation': 'Tian Y, Ma Y, Fu Y, Zheng JS. Application of n-of-1 Clinical Trials in Personalized Nutrition Research: A Trial Protocol for Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR). Curr Dev Nutr. 2020 Aug 26;4(9):nzaa143. doi: 10.1093/cdn/nzaa143. eCollection 2020 Sep.'}]}, 'descriptionModule': {'briefSummary': 'This is a dietary intervention study in students and staff of Westlake University, which is designed to provide evidence in support of N-of-1 methods as an approach to advance personalized nutrition. The primary aim is using a series of N-of-1 trials to determine the impacts of a high fat, low carbohydrate diet (HF-LC) on glucose metabolism and gut microbiota in subjects versus a low fat, high carbohydrate diet (LF-HC) at both the individual and group level.', 'detailedDescription': 'This study will employ a series of individual N-of-1 trials comparing a high fat, low carbohydrate diet (HF-LC) to a low fat, high carbohydrate diet (LF-HC). Participants will enter the study on a usual diet and will have a 6-day run in period for diet planning and baseline data collection before beginning their intervention. The HF-LC or the LF-HC will be randomized as the starting intervention followed by a wash-out period lasting for 6 days with normal diet between two interventions to eliminate previous intervention effects. Then the participants will be provided with the other diet. Both HF-LC and LF-HC last for 6 days in each set which consists of two wash-out periods and two intervention periods. There will be 3 sets in this study and investigators will aggregate the results of the completed N-of-1 trials across all participants to estimate the group level impacts of HF-LC compared to LF-HC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness and capability to complete the study protocol\n\nExclusion Criteria:\n\n* Inability or unwillingness to approved to provide informed consent\n* Neurological conditions that might affect the assessment of the study measurement\n* Hospitalization or surgery planned within 3 months\n* Gastrointestinal diseases\n* Other serious medical conditions, such as liver, kidney, or systemic disease\n* Women who are pregnant or lactating\n* Tobacco, alcohol, or illicit drug abuse\n* Had taken antibiotics in the past two weeks prior to the start of the trial\n* Participants on a vegan diet\n* Any food allergy\n* Lack of smart phone and data plan for participating caregiver\n* Non-Chinese speaking participants\n* Participating in another concurrent intervention study'}, 'identificationModule': {'nctId': 'NCT04125602', 'acronym': 'WE-MACNUTR', 'briefTitle': 'Westlake N-of-1 Trials for Macronutrient Intake', 'organization': {'class': 'OTHER', 'fullName': 'Westlake University'}, 'officialTitle': 'Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake', 'orgStudyIdInfo': {'id': '20190919ZJS001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High fat low carbohydrate diet', 'interventionNames': ['Other: High fat low carbohydrate diet', 'Other: Low fat high carbohydrate diet']}, {'type': 'EXPERIMENTAL', 'label': 'Low fat high carbohydrate diet', 'interventionNames': ['Other: High fat low carbohydrate diet', 'Other: Low fat high carbohydrate diet']}], 'interventions': [{'name': 'High fat low carbohydrate diet', 'type': 'OTHER', 'otherNames': ['HF-LCD'], 'description': 'Throughout the 6-day intervention, participants are provided with a high fat, low carbohydrate diet (HF-LCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 60%, 15% and 25% respectively while the three macronutrients in the other 3-day diet account for 70%, 15% and 15% respectively. The sequencing of the two diets will be randomized.', 'armGroupLabels': ['High fat low carbohydrate diet', 'Low fat high carbohydrate diet']}, {'name': 'Low fat high carbohydrate diet', 'type': 'OTHER', 'otherNames': ['LF-HCD'], 'description': 'Throughout the 6-day intervention, participants are provided with a low fat, high carbohydrate diet (LF-HCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 20%, 15% and 65% respectively while the three macronutrients in the other 3-day diet account for 10%, 15% and 75% respectively. The sequencing of the two diets will be randomized.', 'armGroupLabels': ['High fat low carbohydrate diet', 'Low fat high carbohydrate diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310024', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Westlake University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Ju-Sheng Zheng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Westlake University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Westlake University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}