Water Consumption, Hydration and Resting Energy Expenditure

NCT03258775 | Completed

• 1 other identifier: 750014-4
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hydration and Resting Metabolism

Keywords

RMR; hydration; substrate oxidation

Outcome Measures

Primary Outcomes (2)

• Resting Metabolic Rate (RMR)

  Resting Metabolic Rate after water intake

  90 minutes

• Substrate oxidation

  Change in substrate oxidation after water intake

  90 minutes

Secondary Outcomes (2)

• blood pressure

  90 minutes

• heart rate

  90 minutes

Study Arms (2)

250ml

ACTIVE COMPARATOR

Other: water intake

500ml

ACTIVE COMPARATOR

Other: water intake

Interventions

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

250ml; 500ml

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• George Mason University: lead

MeSH Terms

Interventions

Drinking

Intervention Hierarchy (Ancestors)

Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 23, 2017
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 23, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share