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

July 31, 2019 updated by: BGI-Shenzhen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • ShenZhen, Guangdong, China, 518083
        • BGI-Shenzhen, Guangdong, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 53 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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;

Exclusion Criteria:

  • with antibiotics in the recent 2 months;
  • Failure to comply with experimental requirement;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Caloric Restriction
3-week low calorie diet
Behavioral: Low Calorie Diet
Low Calorie Diet consisted of ~50% calories of a normal-calorie diet (female, 1000kcal/day; male, 1200kcal/day)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in BMI of all volunteers (n=41) following calorie restriction dietary intervention
Time Frame: at baseline and after 3-week calorie restriction dietary intervention
BMI was be measured via clinic scale.
at baseline and after 3-week calorie restriction dietary intervention
different changes in BMI between enterotype Bacteroides (n=28) and enterotype Prevotella (n=13) follow calorie restriction dietary intervention
Time Frame: at baseline and after 3-week calorie restriction dietary intervention
BMI was be measured via clinic scale.
at baseline and after 3-week calorie restriction dietary intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in concentration of amino acids of 36 volunteers following calorie restriction dietary intervention
Time Frame: at baseline and after 3-week calorie restriction dietary intervention
Fasting blood sample for measurement of 31 amino acids
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
Time Frame: at baseline and after 3-week calorie restriction dietary intervention
Fasting blood sample for measurement of 31 amino acids
at baseline and after 3-week calorie restriction dietary intervention
change in gut microbiota of all volunteers (n=41) following calorie restriction intervention
Time Frame: at baseline and after 3-week calorie restriction dietary intervention
faecal bacterial composition determined from microbiological cultures and deep metagenomic next-generation sequencing of bacterial DNA in fece
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
Time Frame: at baseline and after 3-week calorie restriction dietary intervention
faecal bacterial composition determined from microbiological cultures and deep metagenomic next-generation sequencing of bacterial DNA in fece
at baseline and after 3-week calorie restriction dietary intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BGI-Shenzhen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BGI-20170204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol, Statistical analysis plan and analytic code will release

IPD Sharing Time Frame

analytic code will be available for all the time

IPD Sharing Access Criteria

analytic code will be available at github

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Study Data/Documents

  1. Individual Participant Data Set
    Information comments: cohort description including sex, weigt, weight, age
  2. Analytic Code
    Information comments: The Rmd files are used for this study in each directory
  3. gut microbiota and amino acids profiles
    Information comments: the relative abundance profie of gut micorbiota and the concertration profiles of blood amino acids profile

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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