Water Intake and Weight Control in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Water intake and weight control in older adults - Premeal Water + hypocaloric diet, Water intake and weight control in older adults - Total Daily Water + hypocaloric diet, Water Intake and weight control in older adults - hypocaloric diet alone.
- Who it may be relevant to
- Registry conditions: Overweight and Obesity. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Water intake and weight control in older adults - Premeal Water + hypocaloric diet
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. - Behavioral Water intake and weight control in older adults - Total Daily Water + hypocaloric diet
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. - Behavioral Water Intake and weight control in older adults - hypocaloric diet alone
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 outcome measures
- Body weight change [Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase]
Secondary outcome measures (3)
- Change in appetite sensations [Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase]
- Change in hydration status [Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase]
- Change in executive function (EF) [Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Virginia Tech — Blacksburg
Identifiers
NCT: NCT05843318 · 22-624