Water Intake and Weight Control in Older Adults

Part of paid clinical trials in Blacksburg, Virginia.

Sponsor
Virginia Polytechnic Institute and State University
Study ID
NCT05843318
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Water intake and weight control in older adults - Premeal Water + hypocaloric diet — BEHAVIORAL
    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.
  • Water intake and weight control in older adults - Total Daily Water + hypocaloric diet — BEHAVIORAL
    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.
  • Water Intake and weight control in older adults - hypocaloric diet alone — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Nov 13, 2023
Status verified
Jun 2025
Primary completion
Dec 20, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
375 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pre-meal water + Hypocaloric diet
    premeal water ( 500 ml) before each main meal, three times per day + hypocaloric diet
  • Experimental: Daily water + Hypocaloric diet
    total daily water prescription (1500 ml/d) + hypocaloric diet
  • Active Comparator: Hypocaloric Diet alone
    hypocaloric diet with not instructions regarding water intake

Primary Outcome Measure

Body weight change [ Time Frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia TechBlacksburgVirginia24061
Brenda M Davy, PhD
[email protected]
540-231-6784
Elaina L Marinik, PhD
[email protected]
Brenda M Davy, PhD, RD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Blacksburg, VA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Virginia Tech· Blacksburg, VA

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