NCT06891534

Brief Summary

The goal of this study is to understand the underlying circadian rhythms in subcutaneous adipose tissue of humans with our without continuous feeding and how these are altered in people who have obesity.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
56mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Jul 2021Dec 2030

Study Start

First participant enrolled

July 1, 2021

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

8.4 years

First QC Date

March 17, 2025

Last Update Submit

April 13, 2026

Conditions

Obesity, AbdominalFeeding Patterns

Keywords

circadian rhythmsadipose tissueobesityfeeding pattern

Outcome Measures

Primary Outcomes (1)

  • rhythmicity of circadian clock mRNA in adipose tissue

    Genes from RNA-seq analysis will be defined as statistically rhythmic.

    24 hour

Study Arms (2)

Normal weight participants

ACTIVE COMPARATOR
Other: Continuous FeedingOther: Intermittent feeding

Participants with obesity

ACTIVE COMPARATOR
Other: Continuous FeedingOther: Intermittent feeding

Interventions

Continuous FeedingOTHER

Participants will receive 24-hour continuous feeds through an NG tube

Normal weight participantsParticipants with obesity
Intermittent feedingOTHER

Participants will receive 3 boluses of feeding per day at regular meal times through an NG tube to mimic normal meals.

Normal weight participantsParticipants with obesity

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 20-25 kg/m2 or 30-37 kg/m2
  • For participants with obesity a waist-to-hip ratio of ≥0.95 in males and ≥0.90 in females.
  • sedentary
  • females: non pregnant or breastfeeding
  • ability to provide written informed consent and follow study instructions

You may not qualify if:

  • History of mediations that impact adipocyte/lipid metabolism
  • smoking
  • insomnia
  • sleep apnea
  • sleep medication use
  • employment in night or shift work
  • extreme chronotypes
  • Allergy to lidocaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

RECRUITING

MeSH Terms

Conditions

Obesity, AbdominalFeeding BehaviorObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Central Study Contacts

Kelli A Lytle, PhD

CONTACT

507-255-1488lytle.kelli@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 24, 2025

Study Start

July 1, 2021

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2030

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)