Water Induced Thermogenesis in Obese Children

• 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: Hadassah Medical Organization
• 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 ]
• 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.

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

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