CompletedNot Applicable

Effect of Caloric Content and Timing of Meal on Postprandial Substrate Oxidation and Pulse Wave Analysis

United States20 participantsStarted 2024-11-03

Plain-language summary

The overarching aim of this research is to study the effects of caloric content and timing of meals on measures of postprandial metabolism and cardiovascular response 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males or Females between the ages of 18 and 45 years * 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 antioxidant supplementation (daily multivitamin not included), prescribed non-steroidal anti-inflammatory drugs (NSAIDS), antibiotics, steroids, or probiotics. * Are currently taking any medications for management of cholesterol, diabetes, or body weight/obesity, or are undergoing hormon…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pulse Wave Analysis

Timeframe: Baseline to 60 and 120 minutes postprandial

Postprandial Substrate Oxidation

Timeframe: Baseline to 120 minutes postprandial

Trial details

NCT IDNCT07122765

SponsorGeorge Washington University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-15

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