Overweight and ObesityNCT05843318
Water Intake and Weight Control in Older Adults
A study of Overweight and Obesity, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2023to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 50+ years
- BMI ≥25 kg/m2
- weight stable (+/- 2 kg) in past 6 months
- willing to provide consent and comply with study protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Overweight and Obesity
- Being tested
- 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
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water intake and weight control in older adults - Premeal Water + hypocaloric dietBehavioural
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.
Water intake and weight control in older adults - Total Daily Water + hypocaloric dietBehavioural
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.
Water Intake and weight control in older adults - hypocaloric diet aloneBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-meal water + Hypocaloric diet | Experimental | premeal water ( 500 ml) before each main meal, three times per day + hypocaloric diet Receives: Behavioral: Water intake and weight control in older adults - Premeal Water + hypocaloric diet |
| Daily water + Hypocaloric diet | Experimental | total daily water prescription (1500 ml/d) + hypocaloric diet Receives: Behavioral: Water intake and weight control in older adults - Total Daily Water + hypocaloric diet |
| Hypocaloric Diet alone | Active comparator | hypocaloric diet with not instructions regarding water intake Receives: Behavioral: Water Intake and weight control in older adults - hypocaloric diet alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight change
Body weight change in weight loss and weight loss maintenance phases
Measured: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Secondary outcomes (3)
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.
Measured: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
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.
Measured: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
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.
Measured: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start13 Nov 2023
- Primary completion20 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brenda Davy, Virginia Polytechnic Institute and State University
- Investigators
- Brenda Davy, PhD RDN, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843318
- Sponsor's protocol ID
- 22-624
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water Intake and Weight Control in Older Adults
- ClinicalTrials.gov ID
- NCT05843318
- Acronym / sponsor ID
- 22-624
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-meal water + Hypocaloric diet | Experimental | Behavioral: Water intake and weight control in older adults - Premeal Water + hypocaloric dietpremeal water ( 500 ml) before each main meal, three times per day + hypocaloric diet |
| Daily water + Hypocaloric diet | Experimental | Behavioral: Water intake and weight control in older adults - Total Daily Water + hypocaloric diettotal daily water prescription (1500 ml/d) + hypocaloric diet |
| Hypocaloric Diet alone | Active comparator | Behavioral: Water Intake and weight control in older adults - hypocaloric diet alonehypocaloric diet with not instructions regarding water intake |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 50+ years
- BMI ≥25 kg/m2
- weight stable (+/- 2 kg) in past 6 months
- willing to provide consent and comply with study protocol
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water intake and weight control in older adults - Premeal Water + hypocaloric dietIndividuals 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. | Behavioural | Pre-meal water + Hypocaloric diet |
| Water intake and weight control in older adults - Total Daily Water + hypocaloric dietIndividuals 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. | Behavioural | Daily water + Hypocaloric diet |
| Water Intake and weight control in older adults - hypocaloric diet aloneIndividuals 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. | Behavioural | Hypocaloric Diet alone |
Primary outcome
Body weight change
Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Body weight change in weight loss and weight loss maintenance phases
3 secondary outcomes
Change in appetite sensations
Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Change in hydration status
Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Change in executive function (EF)
Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda Davy, PhD RDN principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Overweight and Obesity, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight change (time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.