ChronoMet: Metabolic and Inflammatory Effects of Eating Timing and Quantity

NCT ID: NCT06161337

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2027-03-05

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Meals

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Chow, MD,MS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lesia Lysne

Role: CONTACT

endores@umn.edu

612-301-7040

Facility Contacts

Oldenburg Niki

Role: primary

Other Identifiers

MED-2023-32162

Identifier Type: -

Identifier Source: org_study_id