ChronoMet: Metabolic and Inflammatory Effects of Eating Timing and Quantity

NCT06161337 | Recruiting

• 1 other identifier: MED-2023-32162
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Experimental group

EXPERIMENTAL

60 young (age 18-65), healthy, normal body mass index subjects for this study.

Dietary Supplement: Meals

Interventions

Meals DIETARY_SUPPLEMENT

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Interventions

Meals

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lisa Chow, MD,MS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lesia Lysne

CONTACT

612-301-7040; endores@umn.edu

Study Design

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

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: February 12, 2024
• Primary Completion: March 5, 2026
• Study Completion (Estimated): March 5, 2027
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

US (1)