ChronoMet: Metabolic and Inflammatory Effects of Eating Timing and Quantity

Healthy Volunteers Clinical Trial

Official title:

ChronoMet: Metabolic and Inflammatory Effects of Eating Timing and Quantity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06161337
• Other study ID #: MED-2023-32162
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: February 15, 2026

Study information

• Verified date: June 2024
• Source: University of Minnesota
• Contact: Lesia Lysne
• Phone: 612-301-7040
• Email: endores[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 15, 2026
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Meals
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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory markers quantification	employ a the MILLIPLEX ® Human Cytokine/Chemokine Multiplex Assay Panel to quantify 50 specific inflammatory markers in the serum samples.	8 months
Primary	quantitative metabolomics on serum samples	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