ChronoMet: Metabolic and Inflammatory Effects of Eating Timing and Quantity

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

• Status: Recruiting
• Conditions: Acute Overeating
• Intervention / Treatment: Dietary supplement: Meals

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lesia Lysne; Phone Number: 612-301-7040; Email: endores@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Oldenburg Niki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ages of 18-30 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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental group; 20 young (age 18-30), healthy, normal body mass index subjects for this study.

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 (8 a.m.) or evening (6 p.m.) consumption of a standardized mixed meal of containing 800 calories (standard control) or 2400 calories (overeating meal) - meals will have the same nutrient composition. The meal components will be weighed before and after consumption to quantify the caloric intake by participant. Participants will also be provided meals preceding each visit to best standardize daily caloric intake and mitigate any secondary effect this may have on results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Lisa Chow, MD,MS, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): February 15, 2026

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 (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Hyperphagia
• 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