We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00487955
First Posted: June 19, 2007
Last Update Posted: June 19, 2007
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.
Information provided by:
Tel-Aviv Sourasky Medical Center
June 18, 2007
June 19, 2007
June 19, 2007
June 2007
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
The Metabolic Contribution of the Human Microbiota to Resting Energy Expenditure
The Metabolic Contribution of the Human Microbiota to Resting Energy Expenditure
The purpose of our study is to evaluate the metabolic contribution of the human microbiota to resting energy expenditure

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.

Observational
Observational Model: Defined Population
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
Gastritis
Procedure: Resting Energy Expenditure examination
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
December 2007
Not Provided

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
Sexes Eligible for Study: All
20 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00487955
TASMC-07-AH-176-CTIL
Yes
Not Provided
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
Not Provided
Study Director: Nachum Vaisman, Prof.
Tel-Aviv Sourasky Medical Center
March 2007