Precision Nutrition Technologies for Obesity Management

NCT07101133 | Not Yet Recruiting DMC

• 1 other identifier: 2023ZD0508300
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Individuals whose weight changes during the weight loss period exceed 5% of their own body weight; dropout rates during weight loss and maintenance periods

  3 months

Study Arms (4)

Control group: Energy-limited balanced diet group

PLACEBO COMPARATOR

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.

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

Intervention group based on clinical phenotype

EXPERIMENTAL

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%.

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

Intervention group based on genetic susceptibility

EXPERIMENTAL

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.

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

Based on genetic susceptibility + intestinal flora intervention group

EXPERIMENTAL

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.

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

Interventions

Control group: Energy-limited balanced diet group 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.

Also known as: Based on clinical phenotype + energy-restricted diet group, Intervention group based on genetic susceptibility, Based on genetic susceptibility + intestinal flora intervention group

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Yuan He: lead

Related Publications (2)

• 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: 22386037 BACKGROUND

• 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.

  PMID: 27115820 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher, professor, doctoral supervisor,

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: August 3, 2025
• Study Start: July 27, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07