Virginia Tech
Blacksburg, Virginia, 24061, United States
Location status: Recruiting
Location contact
Brenda M Davy, PhD
CONTACT
Brenda M Davy, PhD, RD
PRINCIPAL_INVESTIGATOR
Elaina L Marinik, PhD
CONTACT
NCT Number: NCT05843318
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Blacksburg, Virginia, 24061, United States
Location status: Recruiting
Brenda M Davy, PhD
CONTACT
Brenda M Davy, PhD, RD
PRINCIPAL_INVESTIGATOR
Elaina L Marinik, PhD
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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
Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
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.
Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
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.
Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Changes in EF (attention, inhibition) assessed using ePRIME computerized tasks, in weight loss and weight loss maintenance phases. These changes may mediate intervention adherence.
Time frame: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase
Changes in appetite hormones, specifically blood concentrations of ghrelin, PYY 3-36, leptin, and CCK in response to a standardized test meal with an energy content of 25% estimated energy requirements.
Contact information is provided by the study sponsor or research team.
Brenda Davy, PhD RDN
CONTACT
Elaina Marinik, PhD
CONTACT
Virginia Polytechnic Institute and State University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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