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

NCT07122765 | Completed

• 1 other identifier: NCR245996
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.Determine the effect of caloric content on measures of postprandial metabolic flexibility and pulse wave analysis to a mixed meal challenge.
2. 2.Determine the effect of meal timing on measures of postprandial metabolic flexibility and pulse wave analysis to a mixed meal challenge.

Conditions

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

Keywords

Feeding; postprandial; metabolism; pulse wave analysis

Outcome Measures

Primary Outcomes (2)

• Pulse Wave Analysis

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

  Baseline to 60 and 120 minutes postprandial

• Postprandial Substrate Oxidation

  Respiratory Exchange Ratio

  Baseline to 120 minutes postprandial

Study Arms (3)

Eucaloric Morning Mixed Meal Challenge

ACTIVE COMPARATOR

Morning Mixed Meal Challenge (Liquid Shake), 25% of estimated daily caloric need

Other: Mixed Meal Feeding Challenge

Eucaloric Evening Mixed Meal Challenge

EXPERIMENTAL

Evening Mixed Meal Challenge (Liquid Shake), 25% of estimated daily caloric need

Other: Mixed Meal Feeding Challenge

Hypercaloric Morning Mixed Meal Challenge

EXPERIMENTAL

Morning Mixed Meal Challenge (Liquid Shake), 37.5% of estimated daily caloric need

Other: Mixed Meal Feeding Challenge

Interventions

Mixed Meal Feeding Challenge OTHER

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

Eucaloric Evening Mixed Meal Challenge; Eucaloric Morning Mixed Meal Challenge; Hypercaloric Morning Mixed Meal Challenge

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University School of Public Health

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

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 arm randomized cross-over trial

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: November 3, 2024
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: June 2026 upon completion of primary data collection and analysis of primary outcomes
• Access Criteria: Researchers making reasonable requests for data access will be granted permission and access to primary data files. Researchers will be asked to submit a scientific question and rationale for data access along with a data analysis plan. Researchers will intiiate a Data Use Agreement with Principal Investigators.

Locations

US (1)