RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Caloric Content And Timing of Meal On Postprandial Substrate Oxidation And Pulse Wave Analysis

Quick Facts

Study Start:2024-11-03
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07122765

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males or Females between the ages of 18 and 45 years
  2. * Low risk for medical complications as determined by physical activity readiness questionnaire (PARQ).
  3. * Not currently taking antioxidant supplementation, non-steroidal anti-inflammatory drugs (NSAIDS) in a prescribed manner, antibiotics, steroids, or probiotics.
  4. * Not currently taking any medications for management of cholesterol, diabetes, or body weight/obesity, or are undergoing transgender hormone therapy.
  5. * Not currently pregnant
  6. * 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.
  7. * No history of gastrointestinal diseases, such as gastroesophageal reflux disease (GERD), irritable bowel syndrome, Celiac disease, Crohn's disease, or lactose intolerance.
  8. * Considered low risk for food insecurity via the Hunger Vital Sign screener.
  9. * 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.
  1. * Are currently taking any antioxidant supplementation (daily multivitamin not included), prescribed non-steroidal anti-inflammatory drugs (NSAIDS), antibiotics, steroids, or probiotics.
  2. * Are currently taking any medications for management of cholesterol, diabetes, or body weight/obesity, or are undergoing hormone therapy (oral contraceptives not included).
  3. * Are unwilling or unable to comply with study procedures, at the discretion of the investigators.
  4. * Pregnant women - A urine pregnancy test will be conducted prior to any testing procedures.
  5. * 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.
  6. * A history of gastrointestinal diseases, such as gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), Celiac disease, Crohn's disease, or lactose intolerance.
  7. * Deemed high risk for food insecurity via the Hunger Vital Sign screener which is filled out electronically prior to enrollment.
  8. * 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.

Contacts and Locations

Study Contact

Matthew D Barberio, PhD
CONTACT
202-994-1408
mbarberio@gwu.edu
Nicholas Foreman, MS
CONTACT
nforeman22@gwu.edu

Study Locations (Sites)

George Washington University School of Public Health
Washington D.C., District of Columbia, 20052
United States

Collaborators and Investigators

Sponsor: George Washington University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-03
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-11-03
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Feeding
  • postprandial
  • metabolism
  • pulse wave analysis

Additional Relevant MeSH Terms

  • Feeding
  • Metabolism
  • Indirect Calorimetry
  • Blood Flow Velocity
  • Pulse Wave Analysis
  • Pulse Wave Velocity
  • Carbohydrate Metabolism
  • Fatty Acid Metabolism
  • Healthy Participants