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Water Intake and Weight Control in Older Adults

Primary Purpose

Overweight and Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: aged 50+ years BMI 25-40 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

Sites / Locations

  • Virginia Tech

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Pre-meal water + Hypocaloric diet

Daily water + Hypocaloric diet

Hypocaloric Diet alone

Arm Description

premeal water ( 500 ml) before each main meal, three times per day + hypocaloric diet

total daily water prescription (1500 ml/d) + hypocaloric diet

hypocaloric diet with not instructions regarding water intake

Outcomes

Primary Outcome Measures

Body weight change
Body weight change in weight loss and weight loss maintenance phases

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 12, 2023
Last Updated
April 24, 2023
Sponsor
Virginia Polytechnic Institute and State University
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1. Study Identification

Unique Protocol Identification Number
NCT05843318
Brief Title
Water Intake and Weight Control in Older Adults
Official Title
Water Intake and Weight Control in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
375 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-meal water + Hypocaloric diet
Arm Type
Experimental
Arm Description
premeal water ( 500 ml) before each main meal, three times per day + hypocaloric diet
Arm Title
Daily water + Hypocaloric diet
Arm Type
Experimental
Arm Description
total daily water prescription (1500 ml/d) + hypocaloric diet
Arm Title
Hypocaloric Diet alone
Arm Type
Active Comparator
Arm Description
hypocaloric diet with not instructions regarding water intake
Intervention Type
Behavioral
Intervention Name(s)
Water intake and weight control in older adults - Premeal Water + hypocaloric diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Water intake and weight control in older adults - Total Daily Water + hypocaloric diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Water Intake and weight control in older adults - hypocaloric diet alone
Intervention Description
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 Measure Information:
Title
Body weight change
Description
Body weight change in weight loss and weight loss maintenance phases
Time Frame
weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Secondary Outcome Measure Information:
Title
Change in appetite sensations
Description
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.
Time Frame
weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Title
Change in hydration status
Description
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.
Time Frame
weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Title
Change in executive function (EF)
Description
Changes in EF (attention, inhibition) assessed using ePRIME computerized tasks, in weight loss and weight loss maintenance phases. These changes may mediate intervention adherence.
Time Frame
weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Other Pre-specified Outcome Measures:
Title
Changes in appetite hormones
Description
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.
Time Frame
weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 50+ years BMI 25-40 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brenda Davy, PhD RDN
Phone
540-231-6784
Email
bdavy@vt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elaina Marinik, PhD
Phone
540-231-0923
Email
emarinik@vt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda Davy, PhD RDN
Organizational Affiliation
Virginia Polytechnic Institute and State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Tech
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24061
Country
United States

12. IPD Sharing Statement

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Water Intake and Weight Control in Older Adults

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