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

NCT04044118 | Completed DMC

• 1 other identifier: BGI-20170204
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteer

Keywords

gut microbiota; calorie restrition dietary intervention

Outcome Measures

Primary Outcomes (2)

• change in BMI of all volunteers (n=41) following 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

  BMI was be measured via clinic scale.

  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

  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

Study Arms (1)

Caloric Restriction

EXPERIMENTAL

3-week low calorie diet

Behavioral: Low Calorie Diet

Interventions

Low Calorie Diet BEHAVIORAL

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

Caloric Restriction

Eligibility Criteria

• Age: 22 Years - 53 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• BGI-Shenzhen: lead

Study Sites (1)

BGI-Shenzhen, Guangdong, China

Shenzhen, Guangdong, 518083, China

Location

Related Publications (5)

• 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.

  PMID: 27604857 BACKGROUND

• Redman 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.

  PMID: 21123443 BACKGROUND

• Santacruz 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.

  PMID: 19390523 BACKGROUND

• Ott 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.

  PMID: 28931850 BACKGROUND

• Wu 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.

  PMID: 21885731 BACKGROUND

MeSH Terms

Interventions

Caloric Restriction

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: August 5, 2019
• Study Start: April 1, 2017
• Primary Completion: April 30, 2017
• Study Completion: February 4, 2018
• Last Updated: August 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: analytic code will be available for all the time
• Access Criteria: analytic code will be available at github

Locations

CN (1)