Human Intestinal Microbiota in Obesity and Nutritional Transition

NCT ID: NCT01314690

Last Updated: 2011-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-03-31

Brief Summary

The objectives of this study are: 1-To qualify the relationship between the gut microbiota and the host nutritional and metabolic status during dietary transition.2-To define the impact of nutritional transition on the intestinal microbiota and identify metagenomics signatures of nutritional transition.

Detailed Description

French overweight (BMI > 27) and obese people (BMI > 30 kg/m2, N=50) will be submitted to a low calorie diet (1200 Kcal) for 8 weeks. This type of intervention is know to modify the metabolic phenotype and expected to change the gut microbiota. Nutritional interventions are planned for 6 months, each subject being studied before (base line), after the intervention (8 weeks) and 2 months after the low calorie diet has stopped and a diet of weight maintenance will be provided. This protocol will be implemented in the nutrition department of the Pitié Salpétrière Hospital in Paris, within the Centre de Recherche en Nutrition Humaine d'Ile-de-France, where patients will be followed on the clinical, biological and histological levels. Evaluation will include medical history, physical, and nutritional evaluations. They will be excluded of the protocol if they had evidence of acute or chronic inflammatory disease, infectious diseases, cancer and/or known alcohol consumption (> 20g per day), as well as other causes of liver, kidney or heart diseases. Physical evaluation will include weight, height, measures of waist/hip ratio, measure of blood pressure. At each time point, body composition will be measured by dual-energy X-ray absorptiometry performed with a total body scanner (Hologic QDR 2500 densitometer). Resting metabolic rate will be evaluated after a one-hour resting period in supine position. Oxygen consumption (VO2) and carbon dioxide production (VCO2), monitored over 30 min by using an open-circuit ventilated-canopy system (Deltatrac II monitor, Datex Instrumentarium Corp., Helsinki, Finland) calibrated with a reference gas. Blood samples will be obtained systematically for biological parameters including lipids (cholesterol, HDL-Chol, TG), insulin and glucose values and OGTT (enabling the determination of insulin sensitivity parameters, adipokines and inflammatory parameters such as leptin, adiponectin, IL-6, TNF alpha, SAA, hsCRP. Serum will be kept for all supplementary measures. The histopathological evaluation of subcutaneous adipose tissue will be performed to evaluate the adipocyte size and the degree of tissue inflammation. Stools samples will be collected for metagenomic studies.

In addition, blood, urine and fecal water samples will be collected and frozen for subsequent metabonomic analysis, and fecal samples for metaproteomic assessment of the microbiota.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH

Interventions

Caloric transition

6 week low calorie diet followed by 6 week stabilization period

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. BMI 27 to 38 kg/m2

2. age: 25 to 65 years.

3. non diabetic subjects

4. fasting glycemia < 1,26 g/l

Exclusion Criteria

1. SGOT ou SGPT > 2.5x normale

2. Glycemia > 1,26 g/l

3. any other health problem or chronic treatment

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role: collaborator

Pierre and Marie Curie University

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Ceprodi S.A. Kot

INDUSTRY

Sponsor Role: lead

Responsible Party

Assistant publique Hopitaux de Paris

Principal Investigators

Karine Clement, MD, PhD, Prof

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Assistance publique-hopitaux de Paris

Paris, , France

Countries

France

References

Dao MC, Sokolovska N, Brazeilles R, Affeldt S, Pelloux V, Prifti E, Chilloux J, Verger EO, Kayser BD, Aron-Wisnewsky J, Ichou F, Pujos-Guillot E, Hoyles L, Juste C, Dore J, Dumas ME, Rizkalla SW, Holmes BA, Zucker JD, Clement K; MICRO-Obes Consortium. A Data Integration Multi-Omics Approach to Study Calorie Restriction-Induced Changes in Insulin Sensitivity. Front Physiol. 2019 Feb 5;9:1958. doi: 10.3389/fphys.2018.01958. eCollection 2018.

Reference Type: DERIVED

PMID: 30804813 (View on PubMed)

Dao MC, Everard A, Aron-Wisnewsky J, Sokolovska N, Prifti E, Verger EO, Kayser BD, Levenez F, Chilloux J, Hoyles L; MICRO-Obes Consortium; Dumas ME, Rizkalla SW, Dore J, Cani PD, Clement K. Akkermansia muciniphila and improved metabolic health during a dietary intervention in obesity: relationship with gut microbiome richness and ecology. Gut. 2016 Mar;65(3):426-36. doi: 10.1136/gutjnl-2014-308778. Epub 2015 Jun 22.

Reference Type: DERIVED

PMID: 26100928 (View on PubMed)

Kong LC, Holmes BA, Cotillard A, Habi-Rachedi F, Brazeilles R, Gougis S, Gausseres N, Cani PD, Fellahi S, Bastard JP, Kennedy SP, Dore J, Ehrlich SD, Zucker JD, Rizkalla SW, Clement K. Dietary patterns differently associate with inflammation and gut microbiota in overweight and obese subjects. PLoS One. 2014 Oct 20;9(10):e109434. doi: 10.1371/journal.pone.0109434. eCollection 2014.

Reference Type: DERIVED

PMID: 25330000 (View on PubMed)

Kong LC, Wuillemin PH, Bastard JP, Sokolovska N, Gougis S, Fellahi S, Darakhshan F, Bonnefont-Rousselot D, Bittar R, Dore J, Zucker JD, Clement K, Rizkalla S. Insulin resistance and inflammation predict kinetic body weight changes in response to dietary weight loss and maintenance in overweight and obese subjects by using a Bayesian network approach. Am J Clin Nutr. 2013 Dec;98(6):1385-94. doi: 10.3945/ajcn.113.058099. Epub 2013 Oct 30.

Reference Type: DERIVED

PMID: 24172304 (View on PubMed)

Other Identifiers

RCB 2008-A00406-49

Identifier Type: -

Identifier Source: org_study_id