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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Obesity
Intervention Other: Water
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Water
Hide Arm/Group Description obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
Period Title: Overall Study
Started 21
Completed 21
Not Completed 0
Arm/Group Title Water
Hide Arm/Group Description obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
21
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
9.8  (1.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
10
  47.6%
Male
11
  52.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 21 participants
21
resting metabolic rate   [1] 
Mean (Standard Deviation)
Unit of measure:  Kcal/d
Number Analyzed 21 participants
1109  (385)
[1]
Measure Description: resting metabolic rate
1.Primary Outcome
Title Post-drinking Metabolic Rate
Hide Description resting metabolic rate after drinking water
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Water
Hide Arm/Group Description:
obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: kcal/d
1487  (277)
2.Primary Outcome
Title Baseline Metabolic Rate
Hide Description baseline metabolic rate
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Water
Hide Arm/Group Description:
obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: kcal/d
1109  (385)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Water
Hide Arm/Group Description obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
All-Cause Mortality
Water
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Water
Affected / at Risk (%)
Total   0/21 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Water
Affected / at Risk (%)
Total   0/21 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gal Dubnov-Raz
Organization: Hadassah Medical Organization
Phone: +972+54-4570250
EMail: gal-d@bezeqint.net
Layout table for additonal information
Responsible Party: Gal Dubnov-Raz, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00794469    
Other Study ID Numbers: GDR-HMO-CTIL
First Submitted: November 19, 2008
First Posted: November 20, 2008
Results First Submitted: June 21, 2009
Results First Posted: November 25, 2009
Last Update Posted: August 7, 2013