The Metabolic Contribution of the Human Microbiota to Resting Energy Expenditure (A-P-REE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487955
Recruitment Status : Unknown
Verified March 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : June 19, 2007
Last Update Posted : June 19, 2007
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
The purpose of our study is to evaluate the metabolic contribution of the human microbiota to resting energy expenditure

Condition or disease Intervention/treatment
Gastritis Procedure: Resting Energy Expenditure examination

Detailed Description:

There are now >500 million adult humans in the world who are overweight [body mass index (BMI) of 25.0-29.9 kg/m2] and 250 million who are obese (BMI 30 kg/m2). This growing epidemic threatens both industrialized and developing countries and has been accompanied by worldwide increases in obesity-related disorders, including type II diabetes, hypertension, cardiovascular pathology, and nonalcoholic fatty liver disease. In the United States, 64% of adults are overweight or obese, prompting the Surgeon General to designate this condition as the most important public health challenge of our time.

The worldwide obesity epidemic is stimulating efforts to identify host and environmental factors that affect energy balance. The Human gut contains an immense number of microorganisms, collectively known as the microbiota. This community consists of at least 1013 citizens, is dominated by anaerobic bacteria, and includes 500-1,000 species whose collective genomes are estimated to contain 100 times more genes than our own human genome. The microbiota can be viewed as a metabolic "organ" exquisitely tuned to our physiology that performs functions that we have not had to evolve on our own. These functions include the ability to process otherwise indigestible components of our diet, such as plant polysaccharides, and therefore may have an impact on our energy balance.

Comparisons of the distal gut microbiota of genetically obese mice and their lean littermates, as well as those of obese and lean human volunteers have revealed that obesity is associated with changes in the relative abundance of two dominant bacterial divisions, the Bacteroidetes and the Firmicutes. Turnbaugh et al demonstrated through metagenomic and biochemical analyses that these changes affect the metabolic potential of the mouse gut microbiota. Furthermore, this trait is transmissible: colonization of germ-free mice with an 'obese microbiota' results in a significantly greater increase in total body fat than colonization with a 'lean microbiota'. These results identify the gut microbiota as an additional contributing factor to the pathophysiology of obesity. It has been suggested, therefore, that the obese microbiome has an increased capacity to harvest energy from the diet.

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Defined Population
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: The Metabolic Contribution of the Human Microbiota to Resting Energy Expenditure
Study Start Date : June 2007
Estimated Study Completion Date : December 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  • 40 patients that refers to helicobacter pylori treatment
  • Aged 20-60 years old
  • 22 Kg/m2 ≤ BMI ≤ 30 Kg/m2
  • Functional GI trace with permanent stool number
  • Keeping on a permanent diet
  • Written informed consent
  • Stated availability throughout the study period
  • Mental ability to understand and follow the protocol

Exclusion criteria

  • Use of laxatives
  • Confirmed GI tract infections or inflammatory bowel disease
  • Any major chronic illness
  • Pregnancy
  • Participation in other clinical trials
  • Use of oral or intravenous antibiotics during 8 weeks prior to recruitment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00487955

Contact: Nachum Vaisman, Prof. +972-524-266-596
Contact: Aharon Halak, Dr. +972-522-311-929

The Unit of Clinical Nutrition Recruiting
Tel Aviv, Israel
Contact: Nachum Vaisman, Prof.    +972-524-266-596   
Contact: Aharon Ahalak, Dr.    +972-522-311-929   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Study Director: Nachum Vaisman, Prof. Identifier: NCT00487955     History of Changes
Other Study ID Numbers: TASMC-07-AH-176-CTIL
First Posted: June 19, 2007    Key Record Dates
Last Update Posted: June 19, 2007
Last Verified: March 2007

Keywords provided by Tel-Aviv Sourasky Medical Center:
helicobacter pylori
patients with gastritis that refers to helicobacter pylori treatment

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases