The Effects of Hydration on Gut Health and Thinking

Cognitive Change Clinical Trial

— WatUP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05315531
• Other study ID #: WatUP
• Status: Completed
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: July 29, 2022

Study information

• Verified date: January 2024
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change
• Dehydration

Intervention

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.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Division of Nutritional Sciences, University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal microbiota relative abundance	changes in the relative abundance of fecal microbiota	3 weeks (baseline vs. follow-up)
Primary	Plasma lipopolysaccharide (LPS)	changes in circulating LPS	3 weeks (baseline vs. follow-up)
Secondary	Copeptin	changes in plasma copeptin concentration	3 weeks (baseline vs. follow-up)
Secondary	24hr Urine Osmolality	changes in osmolality (mOsmol/kg) of urine samples	3 weeks (baseline vs. follow-up)
Secondary	Attentional accuracy	Accuracy (%) on a computerized flanker task	3 weeks (baseline vs. follow-up)
Secondary	Attentional Reaction Time	Reaction time (ms) on a computerized flanker task	3 weeks (baseline vs. follow-up)
Secondary	Attentional processing speed	P3 event related potential latency (ms) using a computerized flanker task	3 weeks (baseline vs. follow-up)
Secondary	24hr Urine Specific Gravity	changes in specific gravity (USG) of urine samples	3 weeks (baseline vs. follow-up)