Hydration and Resting MetabolismNCT03258775
Water Consumption, Hydration and Resting Energy Expenditure
A study testing water intake in people with Hydration and Resting Metabolism, run by George Mason University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration and Resting Metabolism
- What is being tested?
- water intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 1 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- <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
Show all 9Show fewer
- Consumes, on average, more than 2 alcoholic beverages per day
- More than 5kg of weight change over the past 6 months
- Claustrophobic
About this study
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
- Being tested
- water intake
- Keywords
- RMR, hydration, substrate oxidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water intakeOther
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
| Study group | Role | What they receive |
|---|---|---|
| 250ml | Active comparator | Not described Receives: Other: water intake |
| 500ml | Active comparator | Not described Receives: Other: water intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Metabolic Rate (RMR)
Resting Metabolic Rate after water intake
Measured: 90 minutes
Substrate oxidation
Change in substrate oxidation after water intake
Measured: 90 minutes
Secondary outcomes (2)
blood pressure
Measured: 90 minutes
heart rate
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Oct 2015
- Primary completion1 Jun 2016
- Study completion1 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydration and Resting MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258775
- Sponsor's protocol ID
- 750014-4
- Status last verified
- Aug 2017
- First submitted
- 21 Aug 2017
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water Consumption, Hydration and Resting Energy Expenditure
- ClinicalTrials.gov ID
- NCT03258775
- Acronym / sponsor ID
- 750014-4
- Conditions
- Hydration and Resting Metabolism
- Keywords
- RMR, hydration, substrate oxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 250ml | Active comparator | Other: water intake |
| 500ml | Active comparator | Other: water intake |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water intakeAfter 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 | Other | 250ml, 500ml |
Primary outcome
Resting Metabolic Rate (RMR)
Time frame: 90 minutes
Resting Metabolic Rate after water intake
Substrate oxidation
Time frame: 90 minutes
Change in substrate oxidation after water intake
2 secondary outcomes
blood pressure
Time frame: 90 minutes
heart rate
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Hydration and Resting Metabolism
Active, not recruiting
The Effect of Hydration Status on Substrate Oxidation at Rest and During Light and Moderate Exercise
Hydration Status, Substrate Metabolism During Exercise
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing water intake in people with Hydration and Resting Metabolism, run by George Mason University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Metabolic Rate (RMR) (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.