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Clinical Trials/NCT05315531
NCT05315531
Completed
Not Applicable

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

University of Illinois at Urbana-Champaign1 site in 1 country23 target enrollmentAugust 23, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dehydration
Sponsor
University of Illinois at Urbana-Champaign
Enrollment
23
Locations
1
Primary Endpoint
Fecal microbiota relative abundance
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 23, 2021
End Date
July 29, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Naiman Khan

Associate Professor

University of Illinois at Urbana-Champaign

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
  • Not agree to follow study protocol

Outcomes

Primary Outcomes

Fecal microbiota relative abundance

Time Frame: 3 weeks (baseline vs. follow-up)

changes in the relative abundance of fecal microbiota

Plasma lipopolysaccharide (LPS)

Time Frame: 3 weeks (baseline vs. follow-up)

changes in circulating LPS

Secondary Outcomes

  • Attentional accuracy(3 weeks (baseline vs. follow-up))
  • Attentional Reaction Time(3 weeks (baseline vs. follow-up))
  • 24hr Urine Osmolality(3 weeks (baseline vs. follow-up))
  • Copeptin(3 weeks (baseline vs. follow-up))
  • Attentional processing speed(3 weeks (baseline vs. follow-up))
  • 24hr Urine Specific Gravity(3 weeks (baseline vs. follow-up))

Study Sites (1)

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