NCT00794469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
9 months until next milestone

Results Posted

Study results publicly available

November 25, 2009

Completed
Last Updated

August 7, 2013

Status Verified

November 1, 2008

Enrollment Period

3 months

First QC Date

November 19, 2008

Results QC Date

June 21, 2009

Last Update Submit

August 1, 2013

Conditions

Obesity

Keywords

Resting metabolic rate

Outcome Measures

Primary Outcomes (2)

  • Post-drinking Metabolic Rate

    resting metabolic rate after drinking water

    1 hour

  • Baseline Metabolic Rate

    baseline metabolic rate

    baseline

Study Arms (1)

Water

obese children (body mass index \> 95th percentile for age and sex) that will drink cold water

Other: Water

Interventions

WaterOTHER

Children will drink 10 cc/kg of cold water(4 degrees centigrade)

Water

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • obesity
  • agreement and informed consent

You may not qualify if:

  • non-agreement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Optimal Sport Medicine Center

Jerusalem, Israel

Location

Related Publications (1)

  • 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.

    PMID: 14671205BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Water

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Results Point of Contact

Title
Gal Dubnov-Raz
Organization
Hadassah Medical Organization
gal-d@bezeqint.net
+972+54-4570250

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2008

First Posted

November 20, 2008

Study Start

December 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

August 7, 2013

Results First Posted

November 25, 2009

Record last verified: 2008-11

Locations

IL(1)