Blood Glucose ConcentrationNCT06645431
Effect of Low Water Intake on Glucose Regulation Measured Using Continuous Glucose Monitoring
A study testing Water Intake in people with Blood Glucose Concentration and Blood Glucose Self Monitoring, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
Trial summary
This clinical trial aims to learn if increasing water intake for five days can lower blood glucose in healthy, free-living individuals. The main question it aims to answer is whether increasing water intake will reduce daily blood glucose. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose Concentration, Blood Glucose Self Monitoring
- What is being tested?
- Water Intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to Aug 2025
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 years
- able to provide written and verbal consent
Who cannot join
- diabetes
- pre-diabetes
- pregnancy
- chronic illness
- No past surgery on the digestive tract
- taking any oral contraceptives
Trial locations and contacts
1 site in 1 country.
United States1 site
California Polytechnic State University
San Luis Obispo, California, 93407
About this study
Official title: The Effect of Low Water Intake on Glucose Regulation Measured Using Continuous Glucose Monitoring in a Free-Living Environment
This clinical trial aims to learn if increasing water intake for five days can lower blood glucose in healthy, free-living individuals. The main question it aims to answer is whether increasing water intake will reduce daily blood glucose. Researchers will compare blood glucose when drinking adequate water to when the same individuals drink a low amount of water to see if blood glucose differs with water intake. Participants will be asked to drink a prescribed volume of water over two weeks while wearing a continuous glucose monitor and collecting two urine voids throughout each day.
Read the detailed description
Twenty participants between 18 and 55 will be recruited from San Luis Obispo County using flyers, social media, local channels, and other online methods. Participants must be able to provide written and verbal consent to participate in the study. They must not currently be diagnosed with conditions, including, but not limited to, diabetes, pre-diabetes, pregnancy, and chronic illnesses. They must neither have received any surgery on their digestive tract nor be taking any oral contraceptives.
Surveys will be administered throughout the study consisting of validated surveys, which will be given out to participants via the encrypted data storage intermediary platform RedCap, which creates a unique identifier for each response to a survey and will be used to link responses across the study period for each participant. Participant's personal information will be password-protected and stored separately to be used for follow-up responses by Cal Poly investigators and research staff.
After participants complete the interest form and permit us to contact them, researchers will schedule the first visit to determine if participants are eligible, obtain consent for participation, and complete questionnaires assessing baseline physical activity, fluid intake, and diet. All participant visits will be scheduled through email or in person when the participant is on a prior visit to the laboratory. Any researcher contacting a participant for scheduling will use a Cal Poly email address and will only contact the participant's email provided in the interest form. Any scheduling email sent will follow the attached script. The second visit will occur in person and mark the start of the first six-day intervention. During this visit, researchers will place the continuous glucose monitor and Gene Active sensor and provide participants with resealable containers for urine collection and concealed bags to transport urine samples to the laboratory. Participants will be assigned to treatments in a counterbalanced fashion. For six days, participants will consume either the NAM's recommended total water intake of 2.7 liters per day for women and 3.7 liters per day for men (high water intake group, HWI) or 0.7 liters per day for women and 1 liter per day for men (low water intake group, LWI). Participants will be allowed to consume fluid ad libitum for four days. For the second six days, participants will consume either HWI or LWI, depending on the treatment completed in the first five days. Participants cannot drink fluids other than water and coffee/tea if requested. Water bottles will be provided with the prescribed amount of water for each day. Participants will collect two urine samples daily: a first-morning sample upon waking and an afternoon sample (2:00 PM-5:00 PM). Participants will deliver their urine containers to the laboratory every other day. Urine samples will be analyzed for specific gravity and volume.
In Redcap, participants will complete a daily mood disturbance questionnaire and a weekly solid food-to-water questionnaire. They will also complete daily food fluid intake questionnaires. This will include a urine void survey, where participants will track the number of times they urinated each day. Participants will be asked to align their food intake during the second five-day intervention with the same foods and amounts consumed during the first five-day intervention. During the four-day washout period, participants can eat however they want.
- Being tested
- Water Intake
- Keywords
- Hydration, Blood Glucose, Water Intake, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water IntakeBehavioural
Previous studies have not observed blood glucose with adequate vs. low water intake in a free-living situation. The use of continuous glucose monitors allows this.
| Study group | Role | What they receive |
|---|---|---|
| High water intake | Experimental | For six days, participants will consume the NAM's recommended total water intake of 2.7 liters per day for women and 3.7 liters per day for men Receives: Behavioral: Water Intake |
| Low water intake | Active comparator | For six days, participants will consume 0.7 liters per day for women and 1 liter per day for men. Receives: Behavioral: Water Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily blood glucose
Area under the curve of daily blood glucose
Measured: 14 days
Secondary outcomes (1)
Urine specific gravity
Urine concentration
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Oct 2024
- Primary completion31 Jul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose ConcentrationStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Seal, California Polytechnic State University-San Luis Obispo
- Investigators
- Adam D Seal, Ph.D., Principal investigator, California Polytechnic State University-San Luis Obispo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645431
- Sponsor's protocol ID
- 2023-230-CP
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 16 Oct 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Water Intake on Glucose Regulation Measured Using Continuous Glucose Monitoring in a Free-Living Environment
- ClinicalTrials.gov ID
- NCT06645431
- Acronym / sponsor ID
- 2023-230-CP
- Keywords
- Hydration, Blood Glucose, Water Intake, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 16 Oct 2024 (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.
This clinical trial aims to learn if increasing water intake for five days can lower blood glucose in healthy, free-living individuals. The main question it aims to answer is whether increasing water intake will reduce daily blood glucose. Researchers will compare blood glucose when drinking adequate water to when the same individuals drink a low amount of water to see if blood glucose differs with water intake. Participants will be asked to drink a prescribed volume of water over two weeks while wearing a continuous glucose monitor and collecting two urine voids throughout each day.
Detailed description
Twenty participants between 18 and 55 will be recruited from San Luis Obispo County using flyers, social media, local channels, and other online methods. Participants must be able to provide written and verbal consent to participate in the study. They must not currently be diagnosed with conditions, including, but not limited to, diabetes, pre-diabetes, pregnancy, and chronic illnesses. They must neither have received any surgery on their digestive tract nor be taking any oral contraceptives.
Surveys will be administered throughout the study consisting of validated surveys, which will be given out to participants via the encrypted data storage intermediary platform RedCap, which creates a unique identifier for each response to a survey and will be used to link responses across the study period for each participant. Participant's personal information will be password-protected and stored separately to be used for follow-up responses by Cal Poly investigators and research staff.
After participants complete the interest form and permit us to contact them, researchers will schedule the first visit to determine if participants are eligible, obtain consent for participation, and complete questionnaires assessing baseline physical activity, fluid intake, and diet. All participant visits will be scheduled through email or in person when the participant is on a prior visit to the laboratory. Any researcher contacting a participant for scheduling will use a Cal Poly email address and will only contact the participant's email provided in the interest form. Any scheduling email sent will follow the attached script. The second visit will occur in person and mark the start of the first six-day intervention. During this visit, researchers will place the continuous glucose monitor and Gene Active sensor and provide participants with resealable containers for urine collection and concealed bags to transport urine samples to the laboratory. Participants will be assigned to treatments in a counterbalanced fashion. For six days, participants will consume either the NAM's recommended total water intake of 2.7 liters per day for women and 3.7 liters per day for men (high water intake group, HWI) or 0.7 liters per day for women and 1 liter per day for men (low water intake group, LWI). Participants will be allowed to consume fluid ad libitum for four days. For the second six days, participants will consume either HWI or LWI, depending on the treatment completed in the first five days. Participants cannot drink fluids other than water and coffee/tea if requested. Water bottles will be provided with the prescribed amount of water for each day. Participants will collect two urine samples daily: a first-morning sample upon waking and an afternoon sample (2:00 PM-5:00 PM). Participants will deliver their urine containers to the laboratory every other day. Urine samples will be analyzed for specific gravity and volume.
In Redcap, participants will complete a daily mood disturbance questionnaire and a weekly solid food-to-water questionnaire. They will also complete daily food fluid intake questionnaires. This will include a urine void survey, where participants will track the number of times they urinated each day. Participants will be asked to align their food intake during the second five-day intervention with the same foods and amounts consumed during the first five-day intervention. During the four-day washout period, participants can eat however they want.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High water intake | Experimental | Behavioral: Water IntakeFor six days, participants will consume the NAM's recommended total water intake of 2.7 liters per day for women and 3.7 liters per day for men |
| Low water intake | Active comparator | Behavioral: Water IntakeFor six days, participants will consume 0.7 liters per day for women and 1 liter per day for men. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-55 years
- able to provide written and verbal consent
Key exclusion criteria (6 listed)
- diabetes
- pre-diabetes
- pregnancy
- chronic illness
- No past surgery on the digestive tract
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 IntakePrevious studies have not observed blood glucose with adequate vs. low water intake in a free-living situation. The use of continuous glucose monitors allows this. | Behavioural | High water intake, Low water intake |
Primary outcome
Daily blood glucose
Time frame: 14 days
Area under the curve of daily blood glucose
1 secondary outcome
Urine specific gravity
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
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Postprandial Glucose, Blood Glucose Concentration
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.
Adam D Seal, Ph.D. principal investigator
California Polytechnic State University-San Luis Obispo
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 Blood Glucose Concentration and Blood Glucose Self Monitoring, run by California Polytechnic State University-San Luis Obispo 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Oct 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?
Results are not available in the source record.
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?
Daily blood glucose (time frame: 14 days). 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 16 Oct 2024.