Water Intake and Weight Control in Older Adults

ConditionOverweight and Obesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50+

SponsorVirginia Polytechnic Institute and State University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

aged 50+ years

BMI ≥25 kg/m2

weight stable (+/- 2 kg) in past 6 months

willing to provide consent and comply with study protocol

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

375 Participants

are divided into 3 treatment groups

Group A: Pre-meal water + Hypocaloric dietExperimental treatment 1 intervention

Group B: Daily water + Hypocaloric dietExperimental treatment 1 intervention

Group C: Hypocaloric Diet aloneActive comparator 1 intervention

Trial outcomes