NCT05843318

Water Intake and Weight Control in Older Adults

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Virginia Polytechnic Institute and State University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized controlled intervention trial in adults aged 50+ years with overweight or obesity, which will compare three groups with different diet prescriptions: 1) pre-meal water consumption (500 ml, before each main meal) with a hypocaloric diet; 2) 1500 ml water consumed throughout the day with a hypocaloric diet; 3) hypocaloric diet with no instructions regarding water consumption. Smart water bottles will objectively assess water intake timing and volume. Urine osmolality, urine volume, and serum osmolality will be used as objective indicators of compliance with the water intake prescription. We will investigate changes in perceived hunger and fullness and appetite-regulating hormones as potential mechanisms by which premeal water could improve appetite regulation. We will also investigate the impact of water consumption and hydration on executive function capabilities, which may influence intervention adherence. Although increasing water intake could be an effective weight management strategy, no evidence-based recommendations exist for the timing of water intake needed for this benefit.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Water intake and weight control in older adults - Premeal Water + hypocaloric diet	Individuals will be randomly assigned to one of three groups. All individuals will receive counseling in a structured hypocaloric meal plan (1200-1500 kcal) that is consistent with a healthy dietary pattern as described by the Dietary Guidelines for Americans. This group will receive specific instructions for daily water intake timing and volume.
BEHAVIORAL	Water intake and weight control in older adults - Total Daily Water + hypocaloric diet	Individuals will be randomly assigned to one of three groups. All individuals will receive counseling in a structured hypocaloric meal plan (1200-1500 kcal) that is consistent with a healthy dietary pattern as described by the Dietary Guidelines for Americans. This group will receive specific instructions for total daily water intake.
BEHAVIORAL	Water Intake and weight control in older adults - hypocaloric diet alone	Individuals will be randomly assigned to one of three groups. All individuals will receive counseling in a structured hypocaloric meal plan (1200-1500 kcal) that is consistent with a healthy dietary pattern as described by the Dietary Guidelines for Americans. This group will receive instructions in the hypocaloric diet, without specific fluid intake recommendations.

Timeline

• Start date: 2023-11-13
• Primary completion: 2027-12-20
• Completion: 2028-03-31
• First posted: 2023-05-06
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States