Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Water Induced Thermogenesis in Obese Children

This study has been completed.
Sponsor:
Collaborator:
Eden Springs
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00794469
First received: November 19, 2008
Last updated: August 1, 2013
Last verified: November 2008
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Other: Water

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Water Induced Thermogenesis in Obese Children

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Post-drinking Metabolic Rate [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    resting metabolic rate after drinking water

  • Baseline Metabolic Rate [ Time Frame: baseline ] [ Designated as safety issue: No ]
    baseline metabolic rate
Enrollment: 21
Study Start Date: December 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Water
obese children (body mass index > 95th percentile for age and sex) that will drink cold water
 Other: Water
Children will drink 10 cc/kg of cold water(4 degrees centigrade)

  Eligibility
Ages Eligible for Study:   6 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

obese children participating in a lifestyle education and weight management program.

Criteria

Inclusion Criteria:

  • obesity
  • agreement and informed consent

Exclusion Criteria:

  • non-agreement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794469

Locations
Israel
Hadassah Optimal Sport Medicine Center
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Eden Springs
  More Information

Publications:

Responsible Party: Gal Dubnov-Raz, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00794469     History of Changes
Other Study ID Numbers: GDR-HMO-CTIL
Study First Received: November 19, 2008
Results First Received: June 21, 2009
Last Updated: August 1, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Resting metabolic rate

ClinicalTrials.gov processed this record on February 27, 2015