Water Intake and Weight Control in Older Adults

Not Applicable

Recruiting

• Conditions: Overweight and Obesity
• Interventions: Behavioral: Water intake and weight control in older adults - Premeal Water + hypocaloric diet; Behavioral: Water Intake and weight control in older adults - hypocaloric diet alone; Behavioral: Water intake and weight control in older adults - Total Daily Water + hypocaloric diet

• Registration Number: NCT05843318
• Lead Sponsor: Virginia Polytechnic Institute and State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-06
• Study Start: 2023-11-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2027-06-30
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 375

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-meal water + Hypocaloric diet	Water intake and weight control in older adults - Premeal Water + hypocaloric diet	premeal water ( 500 ml) before each main meal, three times per day + hypocaloric diet
Hypocaloric Diet alone	Water Intake and weight control in older adults - hypocaloric diet alone	hypocaloric diet with not instructions regarding water intake
Daily water + Hypocaloric diet	Water intake and weight control in older adults - Total Daily Water + hypocaloric diet	total daily water prescription (1500 ml/d) + hypocaloric diet

Primary Outcome Measures

Name	Time	Method
Body weight change	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 Outcome Measures

Name	Time	Method
Change in hydration status	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.
Change in appetite sensations	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.
Change in executive function (EF)	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.

Trial Locations

Locations (1)

Virginia Tech; 🇺🇸 Blacksburg, Virginia, United States