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The Effects of Hydration on Gut Health and Thinking (WatUP)

Primary Purpose

Dehydration, Cognitive Change, Gastrointestinal Microbiota

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water Intake
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dehydration

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Illinois at Urbana-ChampaignRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Water Intake

Arm Description

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.

Outcomes

Primary Outcome Measures

Fecal microbiota relative abundance
changes in the relative abundance of fecal microbiota
Plasma lipopolysaccharide (LPS)
changes in circulating LPS

Secondary Outcome Measures

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

Full Information

First Posted
October 1, 2021
Last Updated
April 6, 2022
Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Division of Nutritional Sciences, University of Illinois at Urbana-Champaign
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1. Study Identification

Unique Protocol Identification Number
NCT05315531
Brief Title
The Effects of Hydration on Gut Health and Thinking
Acronym
WatUP
Official Title
Investigating the Effects of Increased Water Consumption on Markers of Gut Health, Microbiota, and Executive Function
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Division of Nutritional Sciences, University of Illinois at Urbana-Champaign

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration, Cognitive Change, Gastrointestinal Microbiota

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm hydration water intake intervention with a baseline urine concentration threshold for eligibility
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Water Intake
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Water Intake
Intervention Description
Participants will increase plain water consumption to at least 70% of the daily adequate intake for Americans depending on their sex.
Primary Outcome Measure Information:
Title
Fecal microbiota relative abundance
Description
changes in the relative abundance of fecal microbiota
Time Frame
3 weeks (baseline vs. follow-up)
Title
Plasma lipopolysaccharide (LPS)
Description
changes in circulating LPS
Time Frame
3 weeks (baseline vs. follow-up)
Secondary Outcome Measure Information:
Title
Copeptin
Description
changes in plasma copeptin concentration
Time Frame
3 weeks (baseline vs. follow-up)
Title
24hr Urine Osmolality
Description
changes in osmolality (mOsmol/kg) of urine samples
Time Frame
3 weeks (baseline vs. follow-up)
Title
Attentional accuracy
Description
Accuracy (%) on a computerized flanker task
Time Frame
3 weeks (baseline vs. follow-up)
Title
Attentional Reaction Time
Description
Reaction time (ms) on a computerized flanker task
Time Frame
3 weeks (baseline vs. follow-up)
Title
Attentional processing speed
Description
P3 event related potential latency (ms) using a computerized flanker task
Time Frame
3 weeks (baseline vs. follow-up)
Title
24hr Urine Specific Gravity
Description
changes in specific gravity (USG) of urine samples
Time Frame
3 weeks (baseline vs. follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naiman A Khan, PhD, RD
Phone
217-300-2197
Email
nakhan2@illinois.edu
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naiman A Khan, PhD, RD
Phone
217-300-2197
Email
nakhan2@illinois.edu
First Name & Middle Initial & Last Name & Degree
Naiman A Khan, PhD, RD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Hydration on Gut Health and Thinking

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