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

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Condition: Obesity
• Intervention: Other: Water
• Enrollment: 21

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Water
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

Baseline Characteristics

Arm/Group Title		Water
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
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

Outcome Measures

1. Primary Outcome

Title	Post-drinking Metabolic Rate
Description	resting metabolic rate after drinking water
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Water
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
Description	baseline metabolic rate
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Water
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Water
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	--/--
Serious Adverse Events
	Water
	Affected / at Risk (%)
Total	0/21 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Water
	Affected / at Risk (%)
Total	0/21 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Gal Dubnov-Raz
• Organization: Hadassah Medical Organization
• Phone: +972+54-4570250
• EMail: gal-d@bezeqint.net

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.

• 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