Increased Water Intake + Diet for Weight Control in Older Adults

Overseen By Elaina Marinik, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Disqualifiers: Uncontrolled hypertension, T2D, CHF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

375 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 4 6 7}

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. ^{2 3 4 6 8}

Research Team

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

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

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 Overview 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.

Participant Groups

Group I: Pre-meal water + Hypocaloric diet Experimental Treatment 1 Intervention

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

Group II: Daily water + Hypocaloric diet Experimental Treatment 1 Intervention

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

Group III: Hypocaloric Diet alone Active Control 1 Intervention

hypocaloric diet with not instructions regarding water intake

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Subcutaneous rehydration for efficient treatment of elderly people during heat-waves]. Schnürle, 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-meal water consumption for weight loss. [2013]

Older adults are particularly at risk for dehydration, which can lead to serious health issues such as longer hospital stays, increased readmission rates, and higher mortality, especially in those with chronic diseases.

This review highlights the importance of recognizing and managing hydration in older adults, providing insights into body water turnover and practical strategies to prevent dehydration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydration Status in Older Adults: Current Knowledge and Future Challenges. Li, S., Xiao, X., Zhang, X.[2023]

A 7-month project aimed at improving hydration in older surgical patients showed a dramatic increase in nurses' compliance with monitoring fluid intake, rising from 5% to 76%.

The average fluid consumption among patients increased significantly from 858.23 ml to 1037.50 ml over three days, highlighting the effectiveness of education and labeling strategies in promoting better hydration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintaining oral hydration in older adults in surgical wards: a best practice implementation project. Seah, KH., Low, APS., Low, JY., et al.[2022]

In a study involving 24 overweight and obese older adults, consuming 500 mL of water 30 minutes before a meal led to a significant reduction in energy intake, decreasing meal consumption by about 13%.

This reduction in meal energy intake was consistent across different sexes, ages, and body mass indices, suggesting that premeal water consumption could be a simple and effective strategy for managing weight in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Water consumption reduces energy intake at a breakfast meal in obese older adults. Davy, BM., Dennis, EA., Dengo, AL., et al.[2021]

Low-intake dehydration is a serious and common issue among older adults, leading to negative health effects such as cognitive decline, reduced quality of life, and increased hospital admissions.

Current methods for assessing dehydration risk are unreliable, and there is a significant need for more research to determine optimal hydration strategies tailored to individual needs and settings for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrative Review of Low-Intake Dehydration in Older Adults. Beck, AM., Seemer, J., Knudsen, AW., et al.[2021]

In a study of 61 sedentary obese men aged around 60 years, both hypocaloric diet (HD) alone and combined with aerobic exercise (AEX+HD) resulted in similar significant weight loss and reductions in fat mass over 10 months.

The combination of AEX with HD did not prevent the loss of fat-free mass during weight loss, indicating that while both methods are effective for weight loss, they have similar impacts on muscle preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of weight loss by diet alone or combined with aerobic exercise on body composition in older obese men. Dengel, DR., Hagberg, JM., Coon, PJ., et al.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Subcutaneous rehydration for efficient treatment of elderly people during heat-waves]. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Water consumption increases weight loss during a hypocaloric diet intervention in middle-aged and older adults. [2021]

3. Australia pubmed.ncbi.nlm.nih.gov

Pre-meal water consumption for weight loss. [2013]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Hydration Status in Older Adults: Current Knowledge and Future Challenges. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Maintaining oral hydration in older adults in surgical wards: a best practice implementation project. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Water consumption reduces energy intake at a breakfast meal in obese older adults. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Narrative Review of Low-Intake Dehydration in Older Adults. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of weight loss by diet alone or combined with aerobic exercise on body composition in older obese men. [2019]