Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-29 @ 8:22 AM
Study NCT ID:
NCT06552403
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2024-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Modified 5:2 Intermittent Fasting Diet on Population With Overweight or Obesity in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-11', 'studyFirstSubmitDate': '2024-07-31', 'studyFirstSubmitQcDate': '2024-08-11', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body measurements', 'timeFrame': '24 weeks after intervention', 'description': 'weight, BMI, and waistline'}, {'measure': 'glycolipid metabolism indicators', 'timeFrame': '24 weeks after intervention', 'description': 'fasting plasma glucose (FPG), fasting plasma insulin (FPI), fasting C-peptide (FCP), triglycerides (TG), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and uric acid.'}, {'measure': 'adipokines', 'timeFrame': '24 weeks after intervention', 'description': 'leptin and lipocalin'}, {'measure': 'inflammatory factors before the modified 5:2 IF diet intervention and after 24 weeks of intervention', 'timeFrame': '24 weeks after intervention', 'description': 'high sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6), and tumor necrosis factor-alpha (TNF-α)'}], 'secondaryOutcomes': [{'measure': 'Change in metabolic components', 'timeFrame': '24 weeks after intervention', 'description': "Participants' metabolic components were analyzed by serum metabolomics analysis. The ultra-high performance liquid chromatography combined with quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS) (Agilent 1290, Agilent Technologies, Inc., USA) was applied to identify metabolites."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight or Obesity']}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.', 'detailedDescription': 'There are fewer studies on the influence of dietary interventions on the Chinese populations with obesity, and the degree of obesity, body fat distribution, dietary pattern and structure, and metabolic status of populations with obesity are different between the Chinese and European populations. The effects of a 5:2 IF dietary intervention on the Chinese population with overweight or obesity are unclear. Therefore, this study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. participants aged 18 to 60 years\n2. participants with a body mass index (BMI) ≥ 24 kg/m2\n3. participants engaged in light physical labor and their weight was relatively stable.\n\nExclusion Criteria:\n\n1. participants taking any medication with an effect on body weight in the three months prior to enrollment;\n2. participants with liver or kidney dysfunction (liver enzymes ≥ 2 times normal; blood creatinine \\> the upper limit of normal);\n3. participants with a history of cardiovascular disease (e.g., coronary heart disease, stroke);\n4. participants with malignant tumors;\n5. women during pregnancy or breastfeeding;\n6. participants deemed unsuitable by the investigator to participate in this trial.'}, 'identificationModule': {'nctId': 'NCT06552403', 'briefTitle': 'Effect of a Modified 5:2 Intermittent Fasting Diet on Population With Overweight or Obesity in China', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Provincial Tongde Hospital'}, 'officialTitle': 'Effect of a Modified 5:2 Intermittent Fasting Diet on Population With Overweight or Obesity in China: A Self-controlled Clinical Trial', 'orgStudyIdInfo': {'id': '5:2 intermittent fasting diet'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified 5:2 IF diet', 'description': 'The modified 5:2 IF diet involves 2 nonconsecutive fasting days (25%-30% of the total required daily energy intake based on ideal body weight) and 5 days of habitual intake (limited total energy intake according to ideal body weight) per week, as well as a 4-week run-in period and a minimum of 6,000 steps of physical activity per day.', 'interventionNames': ['Dietary Supplement: A modified 5:2 intermittent fasting diet']}], 'interventions': [{'name': 'A modified 5:2 intermittent fasting diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The modified 5:2 IF diet involves 2 nonconsecutive fasting days (25%-30% of the total required daily energy intake based on ideal body weight) and 5 days of habitual intake (limited total energy intake according to ideal body weight) per week, as well as a 4-week run-in period and a minimum of 6,000 steps of physical activity per day.', 'armGroupLabels': ['Modified 5:2 IF diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'country': 'China', 'facility': 'Xiaoli Wang', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Xiaoli Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Provincial Tongde Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Provincial Tongde Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xiaoli Wang', 'investigatorAffiliation': 'Zhejiang Provincial Tongde Hospital'}}}}