Calorie Restriction Intervention Induces Enterotype-associated BMI Loss in Nonobese Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- change in BMI of all volunteers (n=41) following calorie restriction dietary intervention
研究概览
简要总结
Calorie restriction (CR), which has the potential effect on weight loss and blood amino acids, has been demonstrated to associate with gut microbiota in humans, especially in obese individuals. However, studies for simultaneously evaluating enterotype-dependent impacts of CR on the gut microbiota and blood amino acids in nonobese individuals are still limited.
Here, 41 nonobese individuals received a 3-week CR diet with approximately 50% fewer calories than a normal diet. The investigators measured individuals' BMI and blood amino acid concentration, along with the gut microbiota before and after the intervention. In this trial, 28 Enterotype Bacteroides (ETB) subjects and 13 Enterotype Prevotella (ETP) subjects were identified before the intervention.
The purpose of this intervention study is to evaluate the effect of calorie restriction on BMI loss, amino acid, and gut microbiota in healthy volunteers of two different enterotypes and provide useful insights for potential application of gut microbiome stratification in personalized nutrition intervention.
详细描述
- Volunteer Recruitment
Volunteer-wanted posters were propagated at the China National Gene Bank in Shenzhen from March to April 2017. A non-obese healthy volunteer was considered if his/her BMI less than 28 kg/m2. 50 individuals met all the criteria and were recruited in this study, and 41 individuals (24 females and 17 males aged 30 ± 6 years old) completed the whole intervention. The study was approved by the institutional review board on bioethics and biosafety of BGI-Shenzhen, Shenzhen (NO. BGI-IRB 17020). All participates were fully informed of the design and purpose of this intervention study and signed a written informed consent letter. 2. Experiment Process
The study included a one-week run-in period (baseline) and a three-week CR dietary intervention period. During the first week (run-in period), all healthy volunteers consumed their usual diet and were encouraged to avoid yogurt, high-fat foods, and alcohol. The CR diet was comprised of ~50% calories of a normal-calorie diet (female, 1000kcal/day; male, 1200kcal/day). It was designed with carbohydrate, fat, and protein as approximately 55%, 30% and 15% of the total energy intake respectively, according to the Dietary Guidelines for Chinese Residents (2016) and nutritionally balanced and a recent large nutritional study in China. Common foods in low-calorie diets such as rice, vegetables, eggs, pork, and beef were prepared in the investigators' study center to control experimental variables introduced by different foods and calorie estimation errors.
Traditional Chinese cooking style - boiled, stir-fried and stewed, were applied for the foods. For each meal, digital scales were used to measure the nutritional and caloric values of different foods and total meal for males and females respectively. 3. Sample and Data Collection
BMI, blood and fecal samples of each volunteer were collected at the investigators' study center at baseline and after the 3-week CR intervention. BMI was measured via the clinic scale. The concentrations of 31 amino acids and derivatives in the fasting serum samples were measured by LC-MS/MS. The gut microbial composition was determined using shotgun metagenomics sequencing of fecal DNA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 53 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI less than 28 kg/m2 and more than 18 kg/m2;
- •without antibiotics in the recent 2 months;
- •regular eating and lifestyle patterns;
- •no international travel in the recent 3 month;
- •without hypertension, diabetes mellitus, gastrointestinal disease and other severe auto-immune disease;
- •without prebiotic or probiotic supplements in the recent 2 months;
排除标准
- •with antibiotics in the recent 2 months;
- •Failure to comply with experimental requirement;
研究组 & 干预措施
Caloric Restriction
3-week low calorie diet
干预措施: Low Calorie Diet (Behavioral)
结局指标
主要结局
change in BMI of all volunteers (n=41) following calorie restriction dietary intervention
时间窗: at baseline and after 3-week calorie restriction dietary intervention
BMI was be measured via clinic scale.
different changes in BMI between enterotype Bacteroides (n=28) and enterotype Prevotella (n=13) follow calorie restriction dietary intervention
时间窗: at baseline and after 3-week calorie restriction dietary intervention
BMI was be measured via clinic scale.
次要结局
- change in concentration of amino acids of 36 volunteers following calorie restriction dietary intervention(at baseline and after 3-week calorie restriction dietary intervention)
- different changes in concentration of 31 amino acids (fasting status) between enterotype Bacteroides (n=25) and enterotype Prevotella (n=11) follow calorie restriction dietary intervention(at baseline and after 3-week calorie restriction dietary intervention)
- change in gut microbiota of all volunteers (n=41) following calorie restriction intervention(at baseline and after 3-week calorie restriction dietary intervention)
- different changes in gut microbiota between enterotype Bacteroides (n=28) and enterotype Prevotella (n=13) follow calorie restriction dietary intervention(at baseline and after 3-week calorie restriction dietary intervention)