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Water Intake and Weight Control in Older Adults

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Site details revised
    v8
  2. Primary completion date: Jun 30, 2028 to Dec 20, 2027
    • Study completion date: Jul 31, 2028 to Mar 31, 2028
    v7
  3. Primary completion date: Jun 30, 2027 to Jun 30, 2028
    • Study completion date: Mar 31, 2028 to Jul 31, 2028
    v6
  4. Eligibility criteria expanded, about 1 wordv5
  5. Primary completion date: Mar 31, 2028 to Jun 30, 2027v4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Jun 2027 to Mar 31, 2028
    • Study completion date: Mar 2028 to Mar 31, 2028
    • Start date: Oct 31, 2023 to Nov 13, 2023
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2023 to Oct 31, 2023
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05843318
Lead Sponsor Virginia Polytechnic Institute and State University
Conditions
(from sponsor)		 Overweight and Obesity
Related terms Obesity, Overweight
Enrollment 375 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov