NCT05843318 Water Intake and Weight Control in Older Adults
| NCT ID | NCT05843318 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virginia Polytechnic Institute and State University |
| Condition | Overweight and Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 375 participants |
| Start Date | 2023-11-13 |
| Primary Completion | 2027-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 375 participants in total. It began in 2023-11-13 with a primary completion date of 2027-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * aged 50+ years * BMI ≥25 kg/m2 * weight stable (+/- 2 kg) in past 6 months * willing to provide consent and comply with study protocol Exclusion Criteria: * 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 & Investigator
Brenda Davy, PhD RDN
PRINCIPAL INVESTIGATOR
Virginia Polytechnic Institute and State University
Frequently Asked Questions
Who can join the NCT05843318 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Overweight and Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05843318 currently recruiting?
Yes, NCT05843318 is actively recruiting participants. Contact the research team at bdavy@vt.edu for enrollment information.
Where is the NCT05843318 trial being conducted?
This trial is being conducted at Blacksburg, United States.
Who is sponsoring the NCT05843318 clinical trial?
NCT05843318 is sponsored by Virginia Polytechnic Institute and State University. The principal investigator is Brenda Davy, PhD RDN at Virginia Polytechnic Institute and State University. The trial plans to enroll 375 participants.
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