Effect of Low Water Intake on Glucose Regulation Measured Using Continuous Glucose Monitoring

NCT06645431 | Enrolling By Invitation

• 1 other identifier: 2023-230-CP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Glucose Concentration; Blood Glucose Self Monitoring

Keywords

Hydration; Blood Glucose; Water Intake; Diabetes

Outcome Measures

Primary Outcomes (1)

• Daily blood glucose

  Area under the curve of daily blood glucose

  14 days

Secondary Outcomes (1)

• Urine specific gravity

  14 days

Study Arms (2)

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

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.

Behavioral: Water Intake

Interventions

Water Intake BEHAVIORAL

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.

High water intake; Low water intake

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years
• able to provide written and verbal consent

You may not qualify if:

• diabetes
• pre-diabetes
• pregnancy
• chronic illness
• No past surgery on the digestive tract
• taking any oral contraceptives

Sponsors & Collaborators

• California Polytechnic State University-San Luis Obispo: lead

Study Sites (1)

California Polytechnic State University

San Luis Obispo, California, 93407, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Drinking

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Adam D Seal, Ph.D.

  California Polytechnic State University-San Luis Obispo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 16, 2024
• Study Start: October 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: August 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)