Human Intestinal Microbiota in Obesity and Nutritional Transition (Micro-Obes)

This study has been completed.
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Recherche Agronomique
Pierre and Marie Curie University
Assistance Publique - Hôpitaux de Paris
Information provided by:
Ceprodi S.A. Kot
ClinicalTrials.gov Identifier:
NCT01314690
First received: March 9, 2011
Last updated: March 11, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Obesity
Other: Caloric transition

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Health Services Research
Official Title: Human Intestinal Microbiota in Obesity and Nutritional Transition

Resource links provided by NLM:


Further study details as provided by Ceprodi S.A. Kot:

Primary Outcome Measures:
  • weight loss [ Designated as safety issue: No ]
  • intestinal microbiota genes [ Designated as safety issue: No ]
    identify new intestinal microbiota at basal levels and follow their evolution during the dietary program by using a sequence based method (SOLiD™ System: a massively sequencing platform).

  • Body fat mass
    using dual-energy X-ray absorptiometry performed with a total body scanner (Hologic QDR 2500 densitometer)

  • Food intake
    using 7 day dietary records at each time point


Secondary Outcome Measures:
  • plasma glucose
  • adipose tissue genes [ Designated as safety issue: No ]
    Microarray


Enrollment: 49
Study Start Date: September 2008
Study Completion Date: March 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Caloric transition
    6 week low calorie diet followed by 6 week stabilization period
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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01314690

Locations
France
Assistance publique-hopitaux de Paris
Paris, France
Sponsors and Collaborators
Ceprodi S.A. Kot
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Recherche Agronomique
Pierre and Marie Curie University
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Karine Clement, MD, PhD, Prof Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Ceprodi S.A. Kot

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karine Clement, Assistant publique Hopitaux de Paris
ClinicalTrials.gov Identifier: NCT01314690     History of Changes
Other Study ID Numbers: RCB 2008-A00406-49
Study First Received: March 9, 2011
Last Updated: March 11, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Ceprodi S.A. Kot:
obesity
low calorie diet
intestinal microbiota
inflammation (systemic and in adipose tissue)
fat mass
Impact of nutritional transition on intestinal microbiota
relation between food intake, clinical parameters and intestinal microbiota

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014