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Completed

NCT Number: NCT07122765

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Washington University School of Public Health

Washington D.C., District of Columbia, 20052, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Mixed Meal Feeding Challenge

Other

Liquid flavored Ensure Plus Shake of varying caloric content based on individual daily estimated caloric need

Primary outcomes

  1. Pulse Wave Analysis

    Time frame: Baseline to 60 and 120 minutes postprandial

    Augmentation Index normalized to 75 beats per minute as index of pulse wave reflection

  2. Postprandial Substrate Oxidation

    Time frame: Baseline to 120 minutes postprandial

    Respiratory Exchange Ratio

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Acronym: MetChrono

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2025
Registry last updated
Feb 25, 2026

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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