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Increased Water Intake + Diet for Weight Control in Older Adults
N/A
Recruiting
Led By Brenda Davy, PhD RDN
Research Sponsored by Virginia Polytechnic Institute and State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Awards & highlights
Study Summary
This trial will explore the effects of pre-meal water consumption (500ml) and different water intake levels (1500ml) with a hypocaloric diet on appetite, hormones, and executive function in adults 50+ with overweight/obesity.
Who is the study for?
This trial is for people over 50 who are overweight or obese, with a BMI of 25-40 and stable weight in the last six months. It's not suitable for those with certain medical conditions like uncontrolled high blood pressure, special diet needs due to diseases like diabetes, allergies to specific foods in the test meals, or a history of gastrointestinal issues.Check my eligibility
What is being tested?
The study tests how drinking water before meals or throughout the day combined with a low-calorie diet affects weight loss and appetite control compared to just a low-calorie diet. Participants will be randomly placed into one of three groups and use smart water bottles to track their intake.See study design
What are the potential side effects?
Since this trial involves increased water intake and dietary changes rather than medication, side effects may include increased urination. However, significant adverse effects are unlikely given the nature of the intervention.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body weight change
Secondary outcome measures
Change in appetite sensations
Change in executive function (EF)
Change in hydration status
Other outcome measures
Changes in appetite hormones
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Pre-meal water + Hypocaloric dietExperimental Treatment1 Intervention
premeal water ( 500 ml) before each main meal, three times per day + hypocaloric diet
Group II: Daily water + Hypocaloric dietExperimental Treatment1 Intervention
total daily water prescription (1500 ml/d) + hypocaloric diet
Group III: Hypocaloric Diet aloneActive Control1 Intervention
hypocaloric diet with not instructions regarding water intake
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Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
143 Previous Clinical Trials
27,438 Total Patients Enrolled
9 Trials studying Obesity
4,215 Patients Enrolled for Obesity
Brenda Davy, PhD RDNPrincipal InvestigatorVirginia Polytechnic Institute and State University
1 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is not higher than 159/99 mmHg.I follow a special diet for a health condition like diabetes or heart failure.I have a health issue that stops me from doing physical activities.I have or had a gastrointestinal disease, surgery, or take medicine affecting my GI function.I am 50 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-meal water + Hypocaloric diet
- Group 2: Daily water + Hypocaloric diet
- Group 3: Hypocaloric Diet alone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently seeking participants for this experiment?
"From what is available on clinicaltrials.gov, it appears that recruitment for this trial has concluded. It was first posted in October 1st of 2023 and the last edit occurred on April 24th of the same year. Despite not actively enrolling patients at this time, there are still 356 other studies looking to get participants onboarded."
Answered by AI
Who else is applying?
What site did they apply to?
Virginia Tech
What portion of applicants met pre-screening criteria?
Met criteria
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