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NCT Number: NCT05843318

Water Intake and Weight Control in Older Adults

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Tech

Blacksburg, Virginia, 24061, United States

Location status: Recruiting

Location contact

Brenda M Davy, PhD

CONTACT

[email protected]

540-231-6784

Brenda M Davy, PhD, RD

PRINCIPAL_INVESTIGATOR

Elaina L Marinik, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Body weight change

    Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase

    Body weight change in weight loss and weight loss maintenance phases

Secondary outcomes

  1. Change in appetite sensations

    Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase

    Changes in hunger and fullness, assessed using 100mm Visual Analog Scales (VAS), in weight loss and weight loss maintenance phases. These changes may mediate adherence to the hypocaloric diet and weight loss outcomes.

  2. Change in hydration status

    Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase

    Changes in hydration status, assessed using urine and serum osmolality, urine specific gravity, and serum sodium, in weight loss and weight loss maintenance phases. These changes may mediate intervention adherence.

  3. Change in executive function (EF)

    Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase

    Changes in EF (attention, inhibition) assessed using ePRIME computerized tasks, in weight loss and weight loss maintenance phases. These changes may mediate intervention adherence.

Other outcomes

  1. Changes in appetite hormones

    Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase

    Changes in appetite hormones, specifically blood concentrations of ghrelin, PYY 3-36, leptin, and CCK in response to a standardized test meal with an energy content of 25% estimated energy requirements.

Study contacts

Contact information is provided by the study sponsor or research team.

Brenda Davy, PhD RDN

CONTACT

[email protected]

540-231-6784

Elaina Marinik, PhD

CONTACT

[email protected]

540-231-0923

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 6, 2023
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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