DehydrationWatUPNCT05315531
The Effects of Hydration on Gut Health and Thinking
A study testing Water Intake in people with Dehydration and Cognitive Change, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Cognitive Change, Gastrointestinal Microbiota
- What is being tested?
- Water Intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 29 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Avoid consuming prebiotic and probiotic supplements during study participation
- Not pregnant
- Agree to follow the study protocol
Who cannot join
- <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
Show all 10Show fewer
- intervention
- Not agree with avoiding consuming prebiotic and probiotic supplements during study participation
- Pregnant
- Not agree to follow study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: Investigating the Effects of Increased Water Consumption on Markers of Gut Health, Microbiota, and Executive Function
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.
Read the 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.
- Conditions
- Dehydration, Cognitive Change, Gastrointestinal Microbiota
- Being tested
- Water Intake
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water IntakeDietary supplement
Participants will increase plain water consumption to at least 70% of the daily adequate intake for Americans depending on their sex.
| Study group | Role | What they receive |
|---|---|---|
| Water Intake | Experimental | 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. Receives: Dietary Supplement: Water Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiota relative abundance
changes in the relative abundance of fecal microbiota
Measured: 3 weeks (baseline vs. follow-up)
Plasma lipopolysaccharide (LPS)
changes in circulating LPS
Measured: 3 weeks (baseline vs. follow-up)
Secondary outcomes (6)
Copeptin
changes in plasma copeptin concentration
Measured: 3 weeks (baseline vs. follow-up)
24hr Urine Osmolality
changes in osmolality (mOsmol/kg) of urine samples
Measured: 3 weeks (baseline vs. follow-up)
Attentional accuracy
Accuracy (%) on a computerized flanker task
Measured: 3 weeks (baseline vs. follow-up)
Attentional Reaction Time
Reaction time (ms) on a computerized flanker task
Measured: 3 weeks (baseline vs. follow-up)
Attentional processing speed
P3 event related potential latency (ms) using a computerized flanker task
Measured: 3 weeks (baseline vs. follow-up)
24hr Urine Specific Gravity
changes in specific gravity (USG) of urine samples
Measured: 3 weeks (baseline vs. follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start23 Aug 2021
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm hydration water intake intervention with a baseline urine concentration threshold for eligibility
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Division of Nutritional Sciences, University of Illinois at Urbana-Champaign
- Responsible party
- Principal investigator, Naiman Khan, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315531
- Sponsor's protocol ID
- WatUP
- Acronym
- WatUP
- Status last verified
- Jan 2024
- First submitted
- 1 Oct 2021
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Increased Water Consumption on Markers of Gut Health, Microbiota, and Executive Function
- ClinicalTrials.gov ID
- NCT05315531
- Acronym / sponsor ID
- WatUP / WatUP
- Conditions
- Dehydration, Cognitive Change, Gastrointestinal Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Division of Nutritional Sciences, University of Illinois at Urbana-Champaign
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm hydration water intake intervention with a baseline urine concentration threshold for eligibility
| Arm | Type | Receives |
|---|---|---|
| Water Intake | Experimental | Dietary Supplement: Water Intake3-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. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water IntakeParticipants will increase plain water consumption to at least 70% of the daily adequate intake for Americans depending on their sex. | Dietary supplement | Water Intake |
Primary outcome
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
6 secondary outcomes
Copeptin
Time frame: 3 weeks (baseline vs. follow-up)
24hr Urine Osmolality
Time frame: 3 weeks (baseline vs. follow-up)
Attentional accuracy
Time frame: 3 weeks (baseline vs. follow-up)
Attentional Reaction Time
Time frame: 3 weeks (baseline vs. follow-up)
Attentional processing speed
Time frame: 3 weeks (baseline vs. follow-up)
24hr Urine Specific Gravity
Time frame: 3 weeks (baseline vs. follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Dehydration
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Not yet recruitingPhase 2
Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Cholera (Disorder)
Recruiting
Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
Obesity & Overweight, Type 2 Diabetes
Recruiting
Hydration & Female Life Stages
Dehydration, Menstruation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Intake in people with Dehydration and Cognitive Change, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microbiota relative abundance (time frame: 3 weeks (baseline vs. follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.