Calorie Restriction Intervention Induces Enterotype-associated BMI Loss in Nonobese Individuals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-02-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Caloric Restriction and Exercise on Body Weight, Immune Function, and Intestinal Flora

NCT04275440

Cardiometabolic Risk Weight Loss Immune System +1 more

COMPLETED NA

The Intervention Study of Dietary Intake on Energy Expenditure

NCT03231618

Healthy and Overweight/ Obesity Males

COMPLETED NA

Dynamic Effects of Different Dietary Interventions on Visceral Fat and Biochemical Markers

NCT06754306

Energy Metabolism

COMPLETED NA

Low-Carbohydrate Diet Intervention on Body Weight

NCT01358890

Over Weight Obesity

COMPLETED PHASE2/PHASE3

The Effects of a Very Low Carbohydrate Diet Intervention on Weight Control in Overweight/Obese Patients in China

NCT02283151

Overweight

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Caloric Restriction

3-week low calorie diet

Group Type EXPERIMENTAL

Low Calorie Diet

Intervention Type BEHAVIORAL

Low Calorie Diet consisted of \~50% calories of a normal-calorie diet (female, 1000kcal/day; male, 1200kcal/day)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low Calorie Diet

Low Calorie Diet consisted of \~50% calories of a normal-calorie diet (female, 1000kcal/day; male, 1200kcal/day)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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;