Effect of Caloric Content and Timing of Meal on Postprandial Substrate Oxidation and Pulse Wave Analysis
NCT ID: NCT07122765
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-11-03
2026-12-31
Brief Summary
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1. Determine the effect of caloric content on measures of postprandial metabolic flexibility and pulse wave analysis to a mixed meal challenge.
2. Determine the effect of meal timing on measures of postprandial metabolic flexibility and pulse wave analysis to a mixed meal challenge.
Hypothesis: 1) that hypercaloric meals will result in significantly reduced indices of metabolic flexibility and pulse wave analysis as compared to eucaloric meals and 2) eucaloric meals consumed later in the day will result in significantly reduced metabolic flexibility and pulse wave analysis as compared to eucaloric meals consumed in the morning.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Eucaloric Morning Mixed Meal Challenge
Morning Mixed Meal Challenge (Liquid Shake), 25% of estimated daily caloric need
Mixed Meal Feeding Challenge
Liquid flavored Ensure Plus Shake of varying caloric content based on individual daily estimated caloric need
Eucaloric Evening Mixed Meal Challenge
Evening Mixed Meal Challenge (Liquid Shake), 25% of estimated daily caloric need
Mixed Meal Feeding Challenge
Liquid flavored Ensure Plus Shake of varying caloric content based on individual daily estimated caloric need
Hypercaloric Morning Mixed Meal Challenge
Morning Mixed Meal Challenge (Liquid Shake), 37.5% of estimated daily caloric need
Mixed Meal Feeding Challenge
Liquid flavored Ensure Plus Shake of varying caloric content based on individual daily estimated caloric need
Interventions
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Mixed Meal Feeding Challenge
Liquid flavored Ensure Plus Shake of varying caloric content based on individual daily estimated caloric need
Eligibility Criteria
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Inclusion Criteria
* Low risk for medical complications as determined by physical activity readiness questionnaire (PARQ).
* Not currently taking antioxidant supplementation, non-steroidal anti-inflammatory drugs (NSAIDS) in a prescribed manner, antibiotics, steroids, or probiotics.
* Not currently taking any medications for management of cholesterol, diabetes, or body weight/obesity, or are undergoing transgender hormone therapy.
* Not currently pregnant
* No history of disordered eating, including anorexia nervosa, bulimia nervosa, binge eating disorder, or avoidant restrictive food intake disorder or screened as high risk for disordered eating via validated questionnaire.
* No history of gastrointestinal diseases, such as gastroesophageal reflux disease (GERD), irritable bowel syndrome, Celiac disease, Crohn's disease, or lactose intolerance.
* Considered low risk for food insecurity via the Hunger Vital Sign screener.
* Cannot have followed a ketogenic diet within the last three months or have been told to avoid a high-fat diet by a medical provider due to cardiovascular disease risk.
Exclusion Criteria
* Are currently taking any medications for management of cholesterol, diabetes, or body weight/obesity, or are undergoing hormone therapy (oral contraceptives not included).
* Are unwilling or unable to comply with study procedures, at the discretion of the investigators.
* Pregnant women - A urine pregnancy test will be conducted prior to any testing procedures.
* A history of disordered eating, including anorexia nervosa, bulimia nervosa, binge eating disorder, or avoidant restrictive food intake disorder or deemed high-risk for disordered eating via questionnaire.
* A history of gastrointestinal diseases, such as gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), Celiac disease, Crohn's disease, or lactose intolerance.
* Deemed high risk for food insecurity via the Hunger Vital Sign screener which is filled out electronically prior to enrollment.
* Have followed a ketogenic diet within the last three months or have been told to avoid a high-fat diet by a medical provider for risk of cardiovascular disease.
18 Years
45 Years
ALL
Yes
Sponsors
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George Washington University
OTHER
Responsible Party
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Locations
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George Washington University School of Public Health
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCR245996
Identifier Type: -
Identifier Source: org_study_id
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