Clinical trial NCT05315531: The Effects of Hydration on Gut Health and Thinking
Official title: Investigating the Effects of Increased Water Consumption on Markers of Gut Health, Microbiota, and Executive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Cognitive Change
Gastrointestinal Microbiota
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Division of Nutritional Sciences, University of Illinois at Urbana-Champaign
First posted: 2022-04-07
Enrollment: 23
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm hydration water intake intervention with a baseline urine concentration threshold for eligibility
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Fecal microbiota relative abundance
timeFrame: 3 weeks (baseline vs. follow-up)
measure: Plasma lipopolysaccharide (LPS)
timeFrame: 3 weeks (baseline vs. follow-up)
Secondary outcomes:
measure: Copeptin
timeFrame: 3 weeks (baseline vs. follow-up)
measure: 24hr Urine Osmolality
timeFrame: 3 weeks (baseline vs. follow-up)
measure: Attentional accuracy
timeFrame: 3 weeks (baseline vs. follow-up)
measure: Attentional Reaction Time
timeFrame: 3 weeks (baseline vs. follow-up)
measure: Attentional processing speed
timeFrame: 3 weeks (baseline vs. follow-up)
measure: 24hr Urine Specific Gravity
timeFrame: 3 weeks (baseline vs. follow-up)
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
References: