TrialGlobe

Clinical trial

Water Intake and Weight Control in Older Adults

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05843318

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age50 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionOverweight and Obesity

Full registry 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

Treatments and study arms

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

Body weight changeweeks 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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Virginia Tech🇺🇸 Blacksburg, Virginia, United States
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