- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06161337
ChronoMet: Metabolic and Inflammatory Effects of Eating Timing and Quantity
April 1, 2026 updated by: University of Minnesota
This is an observational study to address the important knowledge gap of the metabolic and inflammatory impact of acute overeating and whether timing of acute overeating may modify these effects.
The hypothesis is that acute overconsumption of calories will promote inflammation and metabolic dysfunction, with the most detrimental effects observed with evening caloric overconsumption.
The expectation is that this study to provide critical insights into the biological consequences of overeating, which will direct novel approaches combating overeating and its detrimental health effects.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55414
- University of Minnesota
-
-
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.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- ages of 18-65 years old
- not pregnant
- no comorbid conditions
- normal BMI (18.5 - 24.9 kg/m2)
- Weight ≥120 lbs self-reported weight
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
60 young (age 18-65), healthy, normal body mass index subjects for this study.
|
Each subject will participate in 4 visits with a 1-week washout period in between visits. Each visit will be either a morning or evening consumption of either a standardized mixed meal of containing 600 calories (standard control) or 2400 calories (overeating meal) - meals will have the same nutrient composition. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammatory markers quantification
Time Frame: 8 months
|
employ a the MILLIPLEX ® Human Cytokine/Chemokine Multiplex Assay Panel to quantify 50 specific inflammatory markers in the serum samples.
|
8 months
|
|
quantitative metabolomics on serum samples
Time Frame: 8 months
|
leverage the University of Minnesota Center for Metabolomics and Proteomics to conduct analysis of serum samples utilizing the Biocrates MxP Quant 500, which provides detailed quantification of over 500 individual metabolites.
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lisa Chow, MD,MS, University of Minnesota
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 Major Dates
Study Start (Actual)
February 28, 2024
Primary Completion (Actual)
December 12, 2024
Study Completion (Actual)
December 12, 2024
Study Registration Dates
First Submitted
November 29, 2023
First Submitted That Met QC Criteria
November 29, 2023
First Posted (Actual)
December 7, 2023
Study Record Updates
Last Update Posted (Actual)
April 3, 2026
Last Update Submitted That Met QC Criteria
April 1, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MED-2023-32162
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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