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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00487955
First received: June 18, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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


Condition Intervention
Gastritis
Procedure: Resting Energy Expenditure examination

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: The Metabolic Contribution of the Human Microbiota to Resting Energy Expenditure

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 40
Study Start Date: June 2007
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487955

Contacts
Contact: Nachum Vaisman, Prof. +972-524-266-596 vaisman@tasmc.health.gov.il
Contact: Aharon Halak, Dr. +972-522-311-929 efratmo@tasmc.health.gov.il

Locations
Israel
The Unit of Clinical Nutrition Recruiting
Tel Aviv, Israel
Contact: Nachum Vaisman, Prof.    +972-524-266-596    vaisman@tasmc.health.gov.il   
Contact: Aharon Ahalak, Dr.    +972-522-311-929    efratmo@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Study Director: Nachum Vaisman, Prof.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00487955     History of Changes
Other Study ID Numbers: TASMC-07-AH-176-CTIL
Study First Received: June 18, 2007
Last Updated: June 18, 2007
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on April 20, 2014