Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-29 @ 3:21 PM
Study NCT ID:
NCT07101133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Nutrition Technologies for Obesity Management
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2025-06-09', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in body weight and BMI ;Changes in abdominal fat (waist circumference, waist-to-height ratio, visceral fat area in the abdomen), and body fat percentage.', 'timeFrame': '3 months', 'description': 'Individuals whose weight changes during the weight loss period exceed 5% of their own body weight; dropout rates during weight loss and maintenance periods'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity and Obesity-related Medical Conditions']}, 'referencesModule': {'references': [{'pmid': '22386037', 'type': 'BACKGROUND', 'citation': 'Gong P, Liang S, Carlton EJ, Jiang Q, Wu J, Wang L, Remais JV. Urbanisation and health in China. Lancet. 2012 Mar 3;379(9818):843-52. doi: 10.1016/S0140-6736(11)61878-3.'}, {'pmid': '27115820', 'type': 'BACKGROUND', 'citation': 'NCD Risk Factor Collaboration (NCD-RisC). Trends in adult body-mass index in 200 countries from 1975 to 2014: a pooled analysis of 1698 population-based measurement studies with 19.2 million participants. Lancet. 2016 Apr 2;387(10026):1377-1396. doi: 10.1016/S0140-6736(16)30054-X.'}]}, 'descriptionModule': {'briefSummary': "The implementation of this project will develop and apply precision health dietary solutions tailored for weight management in China's obese population, establishing a precision nutrition intervention model. Over 50% of the obese individuals are expected to achieve a weight reduction of more than 5%, significantly improving their quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:18 years old to 60 years old, gender not limited. Obesity diagnosis standard, 28≤ BMI (kg/m2)≤ 35 ; Signed informed consent;\n\nExclusion Criteria:Secondary obesity caused by endocrine, genetic, central nervous system diseases or drugs; Merge major disease, tumor, each system organ failure; Had serious infection and acute cardiocerebrovascular diseases; Over the past three months in three months, or drug or surgical treatment has been put on a diet; Pregnancy, for pregnant and nursing women; Mental disorders, or physical/body movement disorders affect normal activities; 5 kg weight fluctuation in the past two months; Daily alcohol consumption quantity more than 25 g for man, women more than 15 g.'}, 'identificationModule': {'nctId': 'NCT07101133', 'briefTitle': 'Precision Nutrition Technologies for Obesity Management', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Research on Key Technologies of Precision Nutrition for Obesity Intervention', 'orgStudyIdInfo': {'id': '2023ZD0508300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group: Energy-limited balanced diet group', 'description': 'Standardized energy-restricted balanced dietary intervention was provided. The intake for men was 1350kcal/d, and for women it was 1100kcal/d. The proportions of the three major nutrients were 50-65% carbohydrates, 20-30% fats, and 15-20% proteins.', 'interventionNames': ['Dietary Supplement: Control group: Energy-limited balanced diet group']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group based on clinical phenotype', 'description': 'Based on subjects baseline diet quality assessment (by FFQ questionnaires and 3 diet records) and baseline clinical data (blood glucose, blood lipid, CRP, etc.), formulate diet plan, targeted adjust the types and proportions of food, mainly includes the following three types: Scheme 1: A low fat diet intake of 1350 kcal/d pattern men, women of 1100 kcal/d, compared with three major nutrients carbohydrate 62%, fat 20%, protein 18%. Scheme 2: low carbohydrate diet intake of 1350 kcal/d pattern men, women of 1100 kcal/d, three major nutrients ratio of carbohydrate, 37% fat, 45% protein, 18%. Solution 3: limited energy balanced diet provide a standardized and balanced energy-restricted diet (1,350 kcal/d for men and 1,100 kcal/d for women), with the proportion of the three major nutrients being 54% carbohydrates, 28% fats, and 18% proteins. Staple meal replacement: Replace two meals a day with full-nutrition meal replacement , wwith a calorie content of 30 to 40%.', 'interventionNames': ['Dietary Supplement: Control group: Energy-limited balanced diet group']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group based on genetic susceptibility', 'description': 'Integrate deep phenotypes (diet quality, physical fitness test results, clinical indicators), superimpose obesity nutrition gene data, including the test results of 33 obesity-related genes (such as FTO, MC4R) and nutrient metabolism genes (such as APOA2, PPARG), and customize the macronutrient ratio (such as adopting a low-carbohydrate diet for those with high carbohydrate sensitivity). Dietary patterns mainly include low-fat dietary patterns, low-carb and low-fat dietary patterns, and balanced energy-restricted dietary patterns. Staple meal replacement: The same meal replacement plan as the deep phenotype group.', 'interventionNames': ['Dietary Supplement: Control group: Energy-limited balanced diet group']}, {'type': 'EXPERIMENTAL', 'label': 'Based on genetic susceptibility + intestinal flora intervention group', 'description': 'Integrating deep phenotypes (diet quality, physical fitness test results, clinical indicators), superimposing obesity nutrition gene + intestinal flora genomic data, including 33 obesity nutrition-related genes and 170 intestinal obesity nutrient metabolic bacterial genera/species test results, to customize the proportion of macronutrients. Dietary patterns mainly include low-fat dietary patterns, low-carb and low-fat dietary patterns, and balanced energy-restricted dietary patterns. Staple meal replacement: The same meal replacement plan as the deep phenotype group.', 'interventionNames': ['Dietary Supplement: Control group: Energy-limited balanced diet group']}], 'interventions': [{'name': 'Control group: Energy-limited balanced diet group', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Based on clinical phenotype + energy-restricted diet group', 'Intervention group based on genetic susceptibility', 'Based on genetic susceptibility + intestinal flora intervention group'], 'description': 'Based on clinical phenotype + energy-restricted diet group：Based on the baseline dietary quality assessment of the subjects and baseline clinical data , a dietary plan was formulated, and the types and proportions of food were adjusted specifically .\n\nIntervention group based on genetic susceptibility：Integrate deep phenotypes (diet quality, physical fitness test results, clinical indicators), superimpose obesity nutrition gene data and nutrient metabolism genes, and customize the macronutrient ratio.\n\nBased on genetic susceptibility + intestinal flora intervention group: Integrating deep phenotypes (diet quality, physical fitness test results, clinical indicators), superimposing obesity nutrition gene + intestinal flora genomic data, including 33 obesity nutrition-related genes and 170 intestinal obesity nutrient metabolic bacterial genera/species test results, to customize the proportion of macronutrients.', 'armGroupLabels': ['Based on genetic susceptibility + intestinal flora intervention group', 'Control group: Energy-limited balanced diet group', 'Intervention group based on clinical phenotype', 'Intervention group based on genetic susceptibility']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuan He', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Researcher, professor, doctoral supervisor,', 'investigatorFullName': 'Yuan He', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}