Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645431
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Effect of Low Water Intake on Glucose Regulation Measured Using Continuous Glucose Monitoring
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Low Water Intake on Glucose Regulation Measured Using Continuous Glucose Monitoring in a Free-Living Environment
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 Participants 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 participants 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 NAMs recommended total water intake of 27 liters per day for women and 37 liters per day for men high water intake group HWI or 07 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 coffeetea 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 200 PM-500 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
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 Participants 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 participants 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 NAMs recommended total water intake of 27 liters per day for women and 37 liters per day for men high water intake group HWI or 07 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 coffeetea 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 200 PM-500 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None