375 Participants Needed

Increased Water Intake + Diet for Weight Control in Older Adults

BD
EM
Overseen ByElaina Marinik, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Virginia Polytechnic Institute and State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on medications that impact gastrointestinal function, you may not be eligible to participate.

What data supports the effectiveness of the treatment for weight control in older adults?

Research shows that drinking 500 mL of water before meals, combined with a low-calorie diet, can lead to greater weight loss in overweight or obese middle-aged and older adults. This approach is easy to implement and has been shown to be effective, with minimal risk of side effects.12345

Is increased water intake with a diet safe for weight control in older adults?

Drinking water before meals as part of a diet plan is generally safe for older adults, but it should be avoided by those with congestive heart failure or severe kidney problems. Adverse effects are unlikely for most people.23467

How does the treatment of increased water intake and diet for weight control in older adults differ from other treatments?

This treatment is unique because it combines increased water intake, specifically drinking 500 mL of water before meals, with a low-calorie diet to enhance weight loss in older adults. Unlike other weight loss methods, this approach leverages the natural appetite-suppressing effect of water, making it a simple and low-risk strategy for managing weight.23468

Research Team

BD

Brenda M Davy, PhD, RD

Principal Investigator

Virginia Polytechnic Institute and State University

Eligibility Criteria

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.

Inclusion Criteria

BMI 25-40
Weight stable (+/- 2 kg) in past 6 months
Willing to provide consent and comply with study protocol
See 1 more

Exclusion Criteria

Usual plain drinking water intake >1500 ml/d
My blood pressure is not higher than 159/99 mmHg.
Allergies or aversions to foods included in the test meals
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Weight Loss Phase

Participants follow a hypocaloric diet with varying water intake prescriptions to assess changes in body weight, appetite hormones, and executive function

12 weeks
Regular visits for monitoring and assessment

Weight Loss Maintenance Phase

Participants continue with the prescribed diet and water intake to maintain weight loss and assess long-term changes in hydration status and executive function

12 months
Periodic follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after the main intervention phases

4 weeks

Treatment Details

Interventions

  • Water Intake and weight control in older adults - hypocaloric diet alone
  • 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
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials
162
Recruited
26,900+

Findings from Research

Geriatric patients are increasingly hospitalized for dehydration, particularly during heat waves, highlighting the need for effective prevention strategies in elderly care settings to reduce hospital admissions and healthcare costs.
Implementing prehospital care structures for oral rehydration and using subcutaneous infusion (hypodermoclysis) can help manage transient dehydration in elderly patients, especially those on multiple medications or experiencing febrile episodes.
[Subcutaneous rehydration for efficient treatment of elderly people during heat-waves].Schnรผrle, J.[2015]
In a study of 48 overweight and obese adults aged 55-75, consuming 500 ml of water before each meal resulted in approximately 2 kg more weight loss over 12 weeks compared to those who did not drink water before meals.
While premeal water consumption initially reduced meal energy intake, this effect was not sustained after 12 weeks, suggesting that the weight loss benefits may primarily come from the combination of water intake with a hypocaloric diet.
Water consumption increases weight loss during a hypocaloric diet intervention in middle-aged and older adults.Dennis, EA., Dengo, AL., Comber, DL., et al.[2021]
Drinking 500 mL of water 30 minutes before meals can enhance weight loss when combined with a low-calorie diet in overweight or obese middle-aged and older adults, supported by NHMRC Level 2 evidence.
This simple intervention is generally safe, but it should be avoided by individuals with congestive heart failure or severe kidney issues.
Pre-meal water consumption for weight loss.[2013]

References

[Subcutaneous rehydration for efficient treatment of elderly people during heat-waves]. [2015]
Water consumption increases weight loss during a hypocaloric diet intervention in middle-aged and older adults. [2021]
Pre-meal water consumption for weight loss. [2013]
Hydration Status in Older Adults: Current Knowledge and Future Challenges. [2023]
Maintaining oral hydration in older adults in surgical wards: a best practice implementation project. [2022]
Water consumption reduces energy intake at a breakfast meal in obese older adults. [2021]
Narrative Review of Low-Intake Dehydration in Older Adults. [2021]
Effects of weight loss by diet alone or combined with aerobic exercise on body composition in older obese men. [2019]