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OpenTrials
Completed

NCT Number: NCT05315531

The Effects of Hydration on Gut Health and Thinking

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.

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Key information

Conditions

Dehydration Cognitive Change Gastrointestinal Microbiota Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water Intake

Dietary Supplement

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

Primary outcomes

  1. Fecal microbiota relative abundance

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

    changes in the relative abundance of fecal microbiota

  2. Plasma lipopolysaccharide (LPS)

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

    changes in circulating LPS

Secondary outcomes

  1. Copeptin

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

    changes in plasma copeptin concentration

  2. 24hr Urine Osmolality

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

    changes in osmolality (mOsmol/kg) of urine samples

  3. Attentional accuracy

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

    Accuracy (%) on a computerized flanker task

  4. Attentional Reaction Time

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

    Reaction time (ms) on a computerized flanker task

  5. Attentional processing speed

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

    P3 event related potential latency (ms) using a computerized flanker task

  6. 24hr Urine Specific Gravity

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

    changes in specific gravity (USG) of urine samples

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

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

Registry information

Official study title

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

Acronym: WatUP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2022
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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