跳至主要内容
临床试验/NCT07101133
NCT07101133尚未招募不适用

Research on Key Technologies of Precision Nutrition for Obesity Intervention

Yuan He0 个研究点目标入组 600 人开始时间: 2025年7月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
600
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Control group: Energy-limited balanced diet group (Dietary Supplement)

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%.

干预措施: Control group: Energy-limited balanced diet group (Dietary Supplement)

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.

干预措施: Control group: Energy-limited balanced diet group (Dietary Supplement)

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.

干预措施: Control group: Energy-limited balanced diet group (Dietary Supplement)

结局指标

主要结局

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.

时间窗: 3 months

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

次要结局

未报告次要终点

研究者

发起方
Yuan He
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yuan He

Researcher, professor, doctoral supervisor,

Chinese PLA General Hospital

相似试验

Precision Nutrition Technologies for Obesity... | 临床试验