Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Water Consumption, Hydration and Resting Energy Expenditure

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: NCT03258775
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
George Mason University

Brief Summary:
A randomized, cross over study will assess the effects of ingestion of high and low volumes of water on REE over 90 minutes. The high volume of water 500ml and the low volume of water 250ml. Participants will be computer randomized to determine which volume of water to receive first. Participants will arrive at the Nutrition Assessment Laboratory between 7:00 and 7:30am following a 9 hour overnight fast. Participants will be instructed not to consume any food or drink after 10pm the night before the assessment. Participants will also be asked to abstain from alcohol and caffeine for 3 days before the assessment. After verification of eligibility, baseline REE will be measured for 30 minutes followed by administration of first assigned dose of water. REE will be monitored for the next 90 minutes. Blood pressure and heart rate will also be monitored, simultaneously to REE. After a 7-10 day washout period, participants will return for their second test day where the second dose of water will be administered. A 7-10 day washout period was selected to allow participants time to resume normal diet and hydration between visits.

Condition or disease Intervention/treatment Phase
Hydration and Resting Metabolism Other: water intake Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Water Consumption, Hydration and Resting Energy Expenditure
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : August 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Active Comparator: 250ml Other: water intake
After an overnight fast participants' RMR will be measured by indirect calorimetry for 30 minutes after which either a low (250ml) or high (500ml) dose of water will be consumed followed by an additional 90 minutes of indirect calorimetry. The test day will be repeated after 7-10 days with the second dose of water. The order in which the dose of water will be consumed will be randomized

Active Comparator: 500ml Other: water intake
After an overnight fast participants' RMR will be measured by indirect calorimetry for 30 minutes after which either a low (250ml) or high (500ml) dose of water will be consumed followed by an additional 90 minutes of indirect calorimetry. The test day will be repeated after 7-10 days with the second dose of water. The order in which the dose of water will be consumed will be randomized




Primary Outcome Measures :
  1. Resting Metabolic Rate (RMR) [ Time Frame: 90 minutes ]
    Resting Metabolic Rate after water intake

  2. Substrate oxidation [ Time Frame: 90 minutes ]
    Change in substrate oxidation after water intake


Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 90 minutes ]
  2. heart rate [ Time Frame: 90 minutes ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-39 years of age
  • Generally Healthy men and women
  • BMI 18.5-28
  • Willing to abstain from caffeine for 3 days prior to testing
  • Able to provide written consent in English
  • Ability to communicate in English (oral and written

Exclusion Criteria:

  • <18 or >39 years
  • BMI < 18.5 or >28
  • Pregnant or Nursing
  • Taking prescribed or over the counter medication affecting fluid balance or metabolism
  • Suffers from hepatic, renal, pulmonary, endocrine or hematological disease
  • Performs more than 3 hours a week of strenuous exercise
  • Consumes, on average, more than 2 alcoholic beverages per day
  • More than 5kg of weight change over the past 6 months
  • Claustrophobic
Layout table for additonal information
Responsible Party: George Mason University
ClinicalTrials.gov Identifier: NCT03258775    
Other Study ID Numbers: 750014-4
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by George Mason University:
RMR
hydration
substrate oxidation