Water Intake and Weight Control in Older Adults
1 other identifier
interventional
375
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
November 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
November 14, 2025
June 1, 2025
4.1 years
April 12, 2023
November 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Body weight change
Body weight change in weight loss and weight loss maintenance phases
weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Secondary Outcomes (3)
Change in appetite sensations
weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Change in hydration status
weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Change in executive function (EF)
weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Other Outcomes (1)
Changes in appetite hormones
weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Study Arms (3)
Pre-meal water + Hypocaloric diet
EXPERIMENTALpremeal water ( 500 ml) before each main meal, three times per day + hypocaloric diet
Daily water + Hypocaloric diet
EXPERIMENTALtotal daily water prescription (1500 ml/d) + hypocaloric diet
Hypocaloric Diet alone
ACTIVE COMPARATORhypocaloric diet with not instructions regarding water intake
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- aged 50+ years
- BMI ≥25 kg/m2
- weight stable (+/- 2 kg) in past 6 months
- willing to provide consent and comply with study protocol
You may not qualify if:
- usual plain drinking water intake \>1500 ml/d
- uncontrolled hypertension (\>159/99 mmHg)
- medical condition requiring specialized diet prescription (eg, T2D, CHF wih fluid restriction)
- medical condition that precludes participating in a physical activity program (eg, orthopedic injury)
- current or history of GI disease (eg, Crohn's), GI surgery, or medications which impact GI function
- allergies or aversions to foods included in the test meals
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Tech
Blacksburg, Virginia, 24061, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brenda Davy, PhD RDN
Virginia Polytechnic Institute and State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 12, 2023
First Posted
May 6, 2023
Study Start
November 13, 2023
Primary Completion (Estimated)
December 20, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
November 14, 2025
Record last verified: 2025-06