FeedingMetChronoNCT07122765
Effect of Caloric Content and Timing of Meal on Postprandial Substrate Oxidation and Pulse Wave Analysis
A study testing Mixed Meal Feeding Challenge in people with Feeding and Metabolism, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Feeding, Metabolism, Indirect Calorimetry
- What is being tested?
- Mixed Meal Feeding Challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2024to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University School of Public Health
Washington D.C., District of Columbia, 20052
About this study
Official title: 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
- Determine the effect of caloric content on measures of postprandial metabolic flexibility and pulse wave analysis to a mixed meal challenge.
- 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.
- Conditions
- Feeding, Metabolism, Indirect Calorimetry, Blood Flow Velocity, Pulse Wave Analysis, Pulse Wave Velocity
- Being tested
- Mixed Meal Feeding Challenge
- Keywords
- Feeding, postprandial, metabolism, pulse wave analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Meal Feeding ChallengeOther
Liquid flavored Ensure Plus Shake of varying caloric content based on individual daily estimated caloric need
| Study group | Role | What they receive |
|---|---|---|
| Eucaloric Morning Mixed Meal Challenge | Active comparator | Morning Mixed Meal Challenge (Liquid Shake), 25% of estimated daily caloric need Receives: Other: Mixed Meal Feeding Challenge |
| Eucaloric Evening Mixed Meal Challenge | Experimental | Evening Mixed Meal Challenge (Liquid Shake), 25% of estimated daily caloric need Receives: Other: Mixed Meal Feeding Challenge |
| Hypercaloric Morning Mixed Meal Challenge | Experimental | Morning Mixed Meal Challenge (Liquid Shake), 37.5% of estimated daily caloric need Receives: Other: Mixed Meal Feeding Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave Analysis
Augmentation Index normalized to 75 beats per minute as index of pulse wave reflection
Measured: Baseline to 60 and 120 minutes postprandial
Postprandial Substrate Oxidation
Respiratory Exchange Ratio
Measured: Baseline to 120 minutes postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start3 Nov 2024
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeedingStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 3 arm randomized cross-over trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122765
- Sponsor's protocol ID
- NCR245996
- Acronym
- MetChrono
- Status last verified
- Feb 2026
- First submitted
- 7 Aug 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized participant data will be shared with researchers upon resonable request and data will be deposited on Open Science Framework
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Caloric Content And Timing of Meal On Postprandial Substrate Oxidation And Pulse Wave Analysis
- ClinicalTrials.gov ID
- NCT07122765
- Acronym / sponsor ID
- MetChrono / NCR245996
- Conditions
- Feeding, Metabolism, Indirect Calorimetry, Blood Flow Velocity, Pulse Wave Analysis, Pulse Wave Velocity
- Keywords
- Feeding, postprandial, metabolism, pulse wave analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 3 Nov 2024 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Determine the effect of caloric content on measures of postprandial metabolic flexibility and pulse wave analysis to a mixed meal challenge.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 arm randomized cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Eucaloric Morning Mixed Meal Challenge | Active comparator | Other: Mixed Meal Feeding ChallengeMorning Mixed Meal Challenge (Liquid Shake), 25% of estimated daily caloric need |
| Eucaloric Evening Mixed Meal Challenge | Experimental | Other: Mixed Meal Feeding ChallengeEvening Mixed Meal Challenge (Liquid Shake), 25% of estimated daily caloric need |
| Hypercaloric Morning Mixed Meal Challenge | Experimental | Other: Mixed Meal Feeding ChallengeMorning Mixed Meal Challenge (Liquid Shake), 37.5% of estimated daily caloric need |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed Meal Feeding ChallengeLiquid flavored Ensure Plus Shake of varying caloric content based on individual daily estimated caloric need | Other | Eucaloric Evening Mixed Meal Challenge, Eucaloric Morning Mixed Meal Challenge, Hypercaloric Morning Mixed Meal Challenge |
Primary outcome
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
Postprandial Substrate Oxidation
Time frame: Baseline to 120 minutes postprandial
Respiratory Exchange Ratio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Yes. Anonymized participant data will be shared with researchers upon resonable request and data will be deposited on Open Science Framework
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Meal Feeding Challenge in people with Feeding and Metabolism, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Wave Analysis (time frame: Baseline to 60 and 120 minutes postprandial). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.