WatUP: The Effects of Hydration on Gut Health and Thinking

Sponsor

University of Illinois at Urbana-Champaign (Other)

Overall Status

Recruiting

CT.gov ID

NCT05315531

Collaborator

Division of Nutritional Sciences, University of Illinois at Urbana-Champaign (Other)

Enrollment

Location

Arm

21.2

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dehydration Cognitive Change Gastrointestinal Microbiota	Dietary Supplement: Water Intake	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single arm hydration water intake intervention with a baseline urine concentration threshold for eligibilitySingle arm hydration water intake intervention with a baseline urine concentration threshold for eligibility

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Investigating the Effects of Increased Water Consumption on Markers of Gut Health, Microbiota, and Executive Function

Actual Study Start Date :

Aug 23, 2021

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

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.	Dietary Supplement: Water Intake Participants will increase plain water consumption to at least 70% of the daily adequate intake for Americans depending on their sex.

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.

Dietary Supplement: Water Intake

Participants will increase plain water consumption to at least 70% of the daily adequate intake for Americans depending on their sex.

Outcome Measures

Primary Outcome Measures

Fecal microbiota relative abundance [3 weeks (baseline vs. follow-up)]
changes in the relative abundance of fecal microbiota
Plasma lipopolysaccharide (LPS) [3 weeks (baseline vs. follow-up)]
changes in circulating LPS

Secondary Outcome Measures

Copeptin [3 weeks (baseline vs. follow-up)]
changes in plasma copeptin concentration
24hr Urine Osmolality [3 weeks (baseline vs. follow-up)]
changes in osmolality (mOsmol/kg) of urine samples
Attentional accuracy [3 weeks (baseline vs. follow-up)]
Accuracy (%) on a computerized flanker task
Attentional Reaction Time [3 weeks (baseline vs. follow-up)]
Reaction time (ms) on a computerized flanker task
Attentional processing speed [3 weeks (baseline vs. follow-up)]
P3 event related potential latency (ms) using a computerized flanker task
24hr Urine Specific Gravity [3 weeks (baseline vs. follow-up)]
changes in specific gravity (USG) of urine samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Urbana-Champaign	Urbana	Illinois	United States	61801

Sponsors and Collaborators

University of Illinois at Urbana-Champaign
Division of Nutritional Sciences, University of Illinois at Urbana-Champaign

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Naiman Khan, Associate Professor, University of Illinois at Urbana-Champaign

ClinicalTrials.gov Identifier:

NCT05315531

Other Study ID Numbers:

WatUP

First Posted:

Apr 7, 2022

Last Update Posted:

Apr 7, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dehydration

Study Results

No Results Posted as of Apr 7, 2022