Water Intake and Weight Control in Older Adults

Overweight and Obesity Clinical Trial

Official title:

Water Intake and Weight Control in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843318
• Other study ID #: 22-624
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: March 31, 2028

Study information

• Verified date: June 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: Brenda Davy, PhD RDN
• Phone: 540-231-6784
• Email: bdavy[@]vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: March 31, 2028
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Virginia Tech	Blacksburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in appetite hormones	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.	weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Primary	Body weight change	Body weight change in weight loss and weight loss maintenance phases	weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Secondary	Change in appetite sensations	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.	weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Secondary	Change in hydration status	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.	weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Secondary	Change in executive function (EF)	Changes in EF (attention, inhibition) assessed using ePRIME computerized tasks, in weight loss and weight loss maintenance phases. These changes may mediate intervention adherence.	weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase