NCT03663530: CM

Circadian Misalignment and Energy Balance

Recruiting now NA Last updated 9 September 2025

What this trial tests

NA trial testing Meal times in Obesity in 42 participants. Currently enrolling.

Timeline

1 January 2019

Primary endpoint
31 July 2026

31 December 2026

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	42
Start date	1 January 2019
Primary completion	31 July 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Meal times

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Columbia University

Who can join

Adults 20 to 49, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Preliminary findings from the investigators' lab suggest that circadian misalignment, occurring when meals and sleep are mistimed from one another, alters resting state neuronal processing in areas relevant to food reward and interoception; supporting a role of sleep and meal misalignment, on energy balance regulation. No study has been done to disentangle the effects of sleep and meal timing on body weight regulation, independent of sleep duration. This study will provide information to guide messaging related to timing of meals and sleep that can be translated to individuals whose sleep follows unconventional times, such as shift workers and those with jetlag and social jetlag.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Actigraphy-Derived Sleep Is Associated with Eating Behavior Characteristics.
   Barragán R, Zuraikat FM, Tam V, Scaccia S, et al · · 2021 · cited 16× · PMID 33807690 · DOI 10.3390/nu13030852
2. Delaying mealtimes reduces fat oxidation: A randomized, crossover, controlled feeding study.
   Carabuena TJ, Boege HL, Bhatti MZ, Whyte KJ, et al · · 2022 · cited 6× · PMID 36238978 · DOI 10.1002/oby.23566
3. Higher daytime intake of fruits and vegetables predicts less disrupted nighttime sleep in younger adults.
   Boege HL, Wilson KD, Kilkus JM, Qiu W, et al · · 2025 · cited 1× · PMID 40506285 · DOI 10.1016/j.sleh.2025.05.003