Precision Nutrition Technologies for Obesity Management

Yuan He

Status: Not yet enrolling

Conditions: Obesity and Obesity-related Medical Conditions

Treatments: Dietary Supplement: Control group: Energy-limited balanced diet group

Study type: Interventional

Funder types: Other

Identifiers

NCT07101133

2023ZD0508300

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 4 patient groups, including a placebo group

Control group: Energy-limited balanced diet group

Placebo Comparator 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.

Treatment:

Dietary Supplement: Control group: Energy-limited balanced diet group

Intervention group based on clinical phenotype

Experimental group

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%.

Treatment:

Dietary Supplement: Control group: Energy-limited balanced diet group

Intervention group based on genetic susceptibility

Experimental group

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.

Treatment:

Dietary Supplement: Control group: Energy-limited balanced diet group

Based on genetic susceptibility + intestinal flora intervention group

Experimental 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.

Treatment:

Dietary Supplement: Control group: Energy-limited balanced diet group