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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if drinking water before meals or throughout the day aids weight control in adults aged 50 and older. Participants will follow a low-calorie diet, with one group drinking water before each meal (premeal water consumption), another consuming a set amount daily (total daily water), and a third group following the diet without special water instructions. The study will also examine how water intake affects hunger, fullness, and brain function. Individuals who have been overweight or obese, maintained a stable weight for the last six months, and can adhere to study instructions might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to enhance understanding of water's role in weight management.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that drinking water before meals is generally safe and can aid in weight loss. Studies have found that consuming about 500 ml of water before each meal helps people lose more weight than dieting alone. This method is usually well-tolerated, with no major safety concerns reported.

Drinking 1500 ml of water spread throughout the day is also supported by research as safe. In studies, adults who added this amount of water to their daily routine experienced weight loss benefits. Again, no significant safety issues have been noted with this level of water intake.

Both methods involve increasing water intake, a natural and low-risk way to potentially enhance weight loss. These practices are generally considered safe for most people. However, individuals should consult a healthcare provider if they have specific health concerns or conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how increased water intake, combined with a low-calorie diet, might help older adults control their weight. Unlike typical weight-loss strategies that may emphasize calorie counting or intense exercise, this approach is straightforward and accessible: one group increases water consumption before meals, and another spreads it throughout the day. The simplicity and potential accessibility of increasing water intake could make this an attractive option for many older adults, offering a new way to support weight management without additional medications or complex programs.

What evidence suggests that this trial's treatments could be effective for weight control in older adults?

This trial will compare different methods of water intake combined with a hypocaloric diet for weight control in older adults. Research has shown that drinking water before meals can aid weight loss. In this trial, one group will drink about two cups of water before each meal. Studies have found that this helps older adults lose more weight than those who don't. This method seems to reduce hunger and decrease food intake during meals. Another group will drink about six cups of water spread throughout the day, which also supports weight control. Studies suggest that people who drink more water daily generally lose more weight and gain less over time. Both methods in this trial indicate that water can be a simple and effective way to manage weight. ^{1 2 4 6 7}

Who Is on the Research Team?

Brenda M Davy, PhD, RD

Principal Investigator

Virginia Polytechnic Institute and State University

Are You a Good Fit for This Trial?

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

Willing to provide consent and comply with study protocol

I am 50 years old or older.

BMI 25-40

Exclusion Criteria

Usual plain drinking water intake >1500 ml/d

Allergies or aversions to foods included in the test meals

My blood pressure is not higher than 159/99 mmHg.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2859815/

Water Consumption Increases Weight Loss During a ... We tested the hypothesis that premeal water consumption would lead to greater weight loss in older overweight and obese individuals consuming a hypocaloric diet ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0031938425001544

Water intake, hydration, and weight management In proof-of-concept studies, we demonstrated that premeal water consumption (500 ml) acutely reduced perceived hunger and meal energy intake ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6209729/

Effect of Pre-meal Water Consumption on Energy Intake ... The results of this study are consistent with the expectation that water consumption may promote weight loss by lowering total energy intake. A ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05843318

Water Intake and Weight Control in Older Adults This study is a randomized controlled intervention trial in adults aged 50+ years with overweight or obesity, which will compare three groups with different ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827021

Outcomes in Randomized Clinical Trials Testing Changes ... Three studies documented greater weight loss in adult participants with an intervention of premeal water intake of approximately 500 mL. Premeal ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523051742

Association between water consumption and body weight ... The aim of this study was to test whether increased premeal water consumption in combination with a behavioral program would be more effective for weight-loss ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19661958/

Water consumption increases weight loss during a ... - PubMed Thus, when combined with a hypocaloric diet, consuming 500 ml water prior to each main meal leads to greater weight loss than a hypocaloric diet alone in middle ...