Water Consumption, Hydration and Resting Energy Expenditure

August 21, 2017 updated by: George Mason University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting Metabolic Rate (RMR)
Time Frame: 90 minutes
Resting Metabolic Rate after water intake
90 minutes
Substrate oxidation
Time Frame: 90 minutes
Change in substrate oxidation after water intake
90 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: 90 minutes
90 minutes
heart rate
Time Frame: 90 minutes
90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Mason University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

August 23, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 750014-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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