Healthy VolunteerCRDINCT04044118
Calorie Restriction Intervention Induces Enterotype-associated BMI Loss in Nonobese Individuals
A study testing Low Calorie Diet in people with Healthy Volunteer, run by BGI-Shenzhen at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 53 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Low Calorie Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 4 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 53 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- with antibiotics in the recent 2 months;
- Failure to comply with experimental requirement;
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- 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.
- 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.
- 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
- Healthy Volunteer
- Being tested
- Low Calorie Diet
- Keywords
- gut microbiota, calorie restrition dietary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Calorie DietBehavioural
Low Calorie Diet consisted of ~50% calories of a normal-calorie diet (female, 1000kcal/day; male, 1200kcal/day)
| Study group | Role | What they receive |
|---|---|---|
| Caloric Restriction | Experimental | 3-week low calorie diet Receives: Behavioral: Low Calorie Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in BMI of all volunteers (n=41) following calorie restriction dietary intervention
BMI was be measured via clinic scale.
Measured: 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
BMI was be measured via clinic scale.
Measured: at baseline and after 3-week calorie restriction dietary intervention
Secondary outcomes (4)
change in concentration of amino acids of 36 volunteers following calorie restriction dietary intervention
Fasting blood sample for measurement of 31 amino acids
Measured: 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
Fasting blood sample for measurement of 31 amino acids
Measured: at baseline and after 3-week calorie restriction dietary intervention
change in gut microbiota of all volunteers (n=41) following calorie restriction intervention
faecal bacterial composition determined from microbiological cultures and deep metagenomic next-generation sequencing of bacterial DNA in fece
Measured: 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
faecal bacterial composition determined from microbiological cultures and deep metagenomic next-generation sequencing of bacterial DNA in fece
Measured: at baseline and after 3-week calorie restriction dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Apr 2017
- Primary completion30 Apr 2017
- Study completion4 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- BGI-Shenzhen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044118
- Sponsor's protocol ID
- BGI-20170204
- Acronym
- CRDI
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical analysis plan and analytic code will release
Publications
Wang SS, Lay S, Yu HN, Shen SR. Dietary Guidelines for Chinese Residents (2016): comments and comparisons. J Zhejiang Univ Sci B. 2016 Sep;17(9):649-56. doi: 10.1631/jzus.B1600341.
PubMed 27604857Redman LM, Huffman KM, Landerman LR, Pieper CF, Bain JR, Muehlbauer MJ, Stevens RD, Wenner BR, Kraus VB, Newgard CB, Kraus WE, Ravussin E. Effect of caloric restriction with and without exercise on metabolic intermediates in nonobese men and women. J Clin Endocrinol Metab. 2011 Feb;96(2):E312-21. doi: 10.1210/jc.2010-1971. Epub 2010 Dec 1.
PubMed 21123443Santacruz A, Marcos A, Warnberg J, Marti A, Martin-Matillas M, Campoy C, Moreno LA, Veiga O, Redondo-Figuero C, Garagorri JM, Azcona C, Delgado M, Garcia-Fuentes M, Collado MC, Sanz Y; EVASYON Study Group. Interplay between weight loss and gut microbiota composition in overweight adolescents. Obesity (Silver Spring). 2009 Oct;17(10):1906-15. doi: 10.1038/oby.2009.112. Epub 2009 Apr 23.
PubMed 19390523Ott B, Skurk T, Hastreiter L, Lagkouvardos I, Fischer S, Buttner J, Kellerer T, Clavel T, Rychlik M, Haller D, Hauner H. Effect of caloric restriction on gut permeability, inflammation markers, and fecal microbiota in obese women. Sci Rep. 2017 Sep 20;7(1):11955. doi: 10.1038/s41598-017-12109-9.
PubMed 28931850Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.
PubMed 21885731
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calorie Restriction Intervention Induces Enterotype-associated BMI Loss in Nonobese Individuals
- ClinicalTrials.gov ID
- NCT04044118
- Acronym / sponsor ID
- CRDI / BGI-20170204
- Conditions
- Healthy Volunteer
- Keywords
- gut microbiota, calorie restrition dietary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- BGI-ShenzhenIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 4 Feb 2018 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caloric Restriction | Experimental | Behavioral: Low Calorie Diet3-week low calorie diet |
Who may qualify
- Ages
- 22 to 53 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- with antibiotics in the recent 2 months;
- Failure to comply with experimental requirement;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Calorie DietLow Calorie Diet consisted of ~50% calories of a normal-calorie diet (female, 1000kcal/day; male, 1200kcal/day) | Behavioural | Caloric Restriction |
Primary outcome
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.
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Background: PubMed 27604857Wang SS, Lay S, Yu HN, Shen SR. Dietary Guidelines for Chinese Residents (2016): comments and comparisons. J Zhejiang Univ Sci B. 2016 Sep;17(9):649-56. doi: 10.1631/jzus.B1600341.
- Background: PubMed 21123443Redman LM, Huffman KM, Landerman LR, Pieper CF, Bain JR, Muehlbauer MJ, Stevens RD, Wenner BR, Kraus VB, Newgard CB, Kraus WE, Ravussin E. Effect of caloric restriction with and without exercise on metabolic intermediates in nonobese men and women. J Clin Endocrinol Metab. 2011 Feb;96(2):E312-21. doi: 10.1210/jc.2010-1971. Epub 2010 Dec 1.
- Background: PubMed 19390523Santacruz A, Marcos A, Warnberg J, Marti A, Martin-Matillas M, Campoy C, Moreno LA, Veiga O, Redondo-Figuero C, Garagorri JM, Azcona C, Delgado M, Garcia-Fuentes M, Collado MC, Sanz Y; EVASYON Study Group. Interplay between weight loss and gut microbiota composition in overweight adolescents. Obesity (Silver Spring). 2009 Oct;17(10):1906-15. doi: 10.1038/oby.2009.112. Epub 2009 Apr 23.
- Background: PubMed 28931850Ott B, Skurk T, Hastreiter L, Lagkouvardos I, Fischer S, Buttner J, Kellerer T, Clavel T, Rychlik M, Haller D, Hauner H. Effect of caloric restriction on gut permeability, inflammation markers, and fecal microbiota in obese women. Sci Rep. 2017 Sep 20;7(1):11955. doi: 10.1038/s41598-017-12109-9.
- Background: PubMed 21885731Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical analysis plan and analytic code will release
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Calorie Diet in people with Healthy Volunteer, run by BGI-Shenzhen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04044118, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.