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Water Induced Thermogenesis in Obese Children

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.
 
ClinicalTrials.gov Identifier: NCT00794469
Recruitment Status : Completed
First Posted : November 20, 2008
Results First Posted : November 25, 2009
Last Update Posted : August 7, 2013
Sponsor:
Collaborator:
Eden Springs
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date November 19, 2008
First Posted Date November 20, 2008
Results First Submitted Date June 21, 2009
Results First Posted Date November 25, 2009
Last Update Posted Date August 7, 2013
Study Start Date December 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2009)
  • Post-drinking Metabolic Rate [ Time Frame: 1 hour ]
    resting metabolic rate after drinking water
  • Baseline Metabolic Rate [ Time Frame: baseline ]
    baseline metabolic rate
Original Primary Outcome Measures
 (submitted: November 19, 2008)
resting metabolic rate [ Time Frame: 2 hours ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Water Induced Thermogenesis in Obese Children
Official Title Water Induced Thermogenesis in Obese Children
Brief Summary Drinking water is largely advocated for obesity prevention and management. Recent studies have suggested that water has a thermogenic effect, this has not been examined in children. In this study, we will measure the resting metabolic rate of 21 obese children before, and during drinking cold (4 degrees centigrade)water for up to 60 minutes.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population obese children participating in a lifestyle education and weight management program.
Condition Obesity
Intervention Other: Water
Children will drink 10 cc/kg of cold water(4 degrees centigrade)
Study Groups/Cohorts Water
obese children (body mass index > 95th percentile for age and sex) that will drink cold water
Intervention: Other: Water
Publications * Boschmann M, Steiniger J, Hille U, Tank J, Adams F, Sharma AM, Klaus S, Luft FC, Jordan J. Water-induced thermogenesis. J Clin Endocrinol Metab. 2003 Dec;88(12):6015-9. doi: 10.1210/jc.2003-030780.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 22, 2009)
21
Original Estimated Enrollment
 (submitted: November 19, 2008)
40
Actual Study Completion Date March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • obesity
  • agreement and informed consent

Exclusion Criteria:

  • non-agreement
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 13 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00794469
Other Study ID Numbers GDR-HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Gal Dubnov-Raz, Hadassah Medical Organization
Original Responsible Party Same as current
Current Study Sponsor Hadassah Medical Organization
Original Study Sponsor Same as current
Collaborators Eden Springs
Investigators Not Provided
PRS Account Hadassah Medical Organization
Verification Date November 2008