- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05315531
The Effects of Hydration on Gut Health and Thinking (WatUP)
January 10, 2024 updated by: Naiman Khan, University of Illinois at Urbana-Champaign
Investigating the Effects of Increased Water Consumption on Markers of Gut Health, Microbiota, and Executive Function
The central hypothesis is that improving hydration through increased water consumption will change the relative abundance of mucolytic bacteria found in the stool.
Therefore the specific aims are 1) to quantify intervention effects on fecal microbiota relative abundance and plasma lipopolysaccharide binding protein, 2) observe the effects of the intervention on bowel frequency and signs/symptoms of gastrointestinal stress, and 3) to investigate relations between executive function and hydration status.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
A single arm 3-week hydration intervention will be employed where participants increase their water consumption to 2 (F) or 2.5(M) liters per day which is approximately 70% of the AI for daily water consumption.
Pre-test and follow-up measures of fecal microbiota, urinary hydration status, cognitive function, circulating markers, and dietary intake will be assessed at baseline and at 3-week follow up via laboratory visits.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- University of Illinois at Urbana-Champaign
-
-
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
19 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 19-50 years of age
- 18.5-34.49 kg/m2
- 24-hour UOsm above 500 mOsm/kg
- No antibiotic use over the past 3 months
- Absence of metabolic diseases and use of diuretics
- Agree to maintain typical diet intake (e.g., dietary fiber) patterns during intervention
- Avoid consuming prebiotic and probiotic supplements during study participation
- Not pregnant
- Agree to follow the study protocol
Exclusion Criteria:
- <19 or >50 years of age
- <18.5 or >34.49 kg/m2
- 24-hour UOsm <500 mOsm/kg
- Antibiotic use over the past 3 months
- Metabolic diseases and use of diuretics
- Not agree to maintain typical diet intake (e.g., dietary fiber) patterns for the duration of the
- intervention
- Not agree with avoiding consuming prebiotic and probiotic supplements during study participation
- Pregnant
- Not agree to follow study protocol
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Water Intake
3-week intervention period during which articipants will be asked to increase their daily plain water consumption to at least 2.5 L/d of water for males and 2L/d for females.
|
Participants will increase plain water consumption to at least 70% of the daily adequate intake for Americans depending on their sex.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fecal microbiota relative abundance
Time Frame: 3 weeks (baseline vs. follow-up)
|
changes in the relative abundance of fecal microbiota
|
3 weeks (baseline vs. follow-up)
|
|
Plasma lipopolysaccharide (LPS)
Time Frame: 3 weeks (baseline vs. follow-up)
|
changes in circulating LPS
|
3 weeks (baseline vs. follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Copeptin
Time Frame: 3 weeks (baseline vs. follow-up)
|
changes in plasma copeptin concentration
|
3 weeks (baseline vs. follow-up)
|
|
24hr Urine Osmolality
Time Frame: 3 weeks (baseline vs. follow-up)
|
changes in osmolality (mOsmol/kg) of urine samples
|
3 weeks (baseline vs. follow-up)
|
|
Attentional accuracy
Time Frame: 3 weeks (baseline vs. follow-up)
|
Accuracy (%) on a computerized flanker task
|
3 weeks (baseline vs. follow-up)
|
|
Attentional Reaction Time
Time Frame: 3 weeks (baseline vs. follow-up)
|
Reaction time (ms) on a computerized flanker task
|
3 weeks (baseline vs. follow-up)
|
|
Attentional processing speed
Time Frame: 3 weeks (baseline vs. follow-up)
|
P3 event related potential latency (ms) using a computerized flanker task
|
3 weeks (baseline vs. follow-up)
|
|
24hr Urine Specific Gravity
Time Frame: 3 weeks (baseline vs. follow-up)
|
changes in specific gravity (USG) of urine samples
|
3 weeks (baseline vs. follow-up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
August 23, 2021
Primary Completion (Actual)
July 29, 2022
Study Completion (Actual)
July 29, 2022
Study Registration Dates
First Submitted
October 1, 2021
First Submitted That Met QC Criteria
April 6, 2022
First Posted (Actual)
April 7, 2022
Study Record Updates
Last Update Posted (Estimated)
January 11, 2024
Last Update Submitted That Met QC Criteria
January 10, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WatUP
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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