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OpenTrials
Completed

NCT Number: NCT03258775

Water Consumption, Hydration and Resting Energy Expenditure

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.

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Key information

Conditions

Hydration and Resting Metabolism

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

water intake

Other

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 outcomes

  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 outcomes

  1. blood pressure

    Time frame: 90 minutes

  2. heart rate

    Time frame: 90 minutes

Sponsors and collaborators

Lead sponsor

George Mason University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 23, 2017
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.