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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06161337
Other study ID # MED-2023-32162
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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