Precision Nutrition Technologies for Obesity Management

NCT ID: NCT07101133

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-27
• Study Completion Date: 2027-06-30

Brief Summary

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.

Conditions

Obesity and Obesity-related Medical Conditions

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Control group: Energy-limited balanced diet group

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.

Group Type: PLACEBO_COMPARATOR

Control group: Energy-limited balanced diet group

Intervention Type: DIETARY_SUPPLEMENT

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 .

Intervention 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.

Based 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.

Intervention group based on clinical phenotype

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%.

Group Type: EXPERIMENTAL

Control group: Energy-limited balanced diet group

Intervention Type: DIETARY_SUPPLEMENT

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 .

Intervention 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.

Based 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.

Intervention group based on genetic susceptibility

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.

Group Type: EXPERIMENTAL

Control group: Energy-limited balanced diet group

Intervention Type: DIETARY_SUPPLEMENT

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 .

Intervention 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.

Based 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.

Based 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. 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.

Group Type: EXPERIMENTAL

Control group: Energy-limited balanced diet group

Intervention Type: DIETARY_SUPPLEMENT

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 .

Intervention 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.

Based 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.

Interventions

Control group: Energy-limited balanced diet group

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 .

Intervention 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.

Based 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Based on clinical phenotype + energy-restricted diet group; Intervention group based on genetic susceptibility; Based on genetic susceptibility + intestinal flora intervention group

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:18 years old to 60 years old, gender not limited. Obesity diagnosis standard, 28≤ BMI (kg/m2)≤ 35 ; Signed informed consent;

Exclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuan He

OTHER

Sponsor Role: lead

Responsible Party

Yuan He

Researcher, professor, doctoral supervisor,

Responsibility Role: SPONSOR_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 22386037 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27115820 (View on PubMed)

Other Identifiers

2023ZD0508300

Identifier Type: -

Identifier Source: org_study_id