Effects of meal timing on energy balance and obesity
Impact of Circadian Misalignment on Energy Balance Regulation
This study is testing if eating meals at different times in relation to sleep can affect weight and health for people who are overweight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 20 Years to 49 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03663530 on ClinicalTrials.gov |
What this trial studies
This study investigates how the timing of meals in relation to sleep affects energy balance and obesity risk. It aims to determine whether eating late in the day influences health markers such as hormones and energy expenditure. Overweight participants will undergo a crossover intervention with two phases: one where meals are aligned with sleep and another where they are misaligned. The study will measure outcomes after specific intervention periods and during a follow-up free-living phase to assess the impact of meal timing on chronic disease risk.
Who should consider this trial
Good fit: Ideal candidates are overweight men and women with a body mass index between 20-34.9 and who maintain an average sleep duration of at least 7 hours per night.
Not a fit: Patients with sleep disorders, psychiatric conditions, or those who work night shifts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized lifestyle recommendations that help reduce obesity and related chronic diseases.
How similar studies have performed: While the specific approach of manipulating meal timing without altering sleep duration is novel, related studies on circadian rhythms and obesity have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All racial and ethnic groups * Body mass index 20-34.9 kg/m2 * Average sleep duration ≥7 hour/night, assessed during 2-week screening period * Eat within 1 hour of awakening at least 5 days/week * Midpoint of sleep at 4 AM or earlier Exclusion Criteria: * \<10 nights of sleep \<7 hour during the 2-week screening period * Daytime napping * Current or past sleep disorder (Sleep Disorders Inventory); Insomnia Severity Index Score \>10 * Current or past psychiatric disorder, including eating disorders and seasonal affective disorder * Any psychological or psychiatric disorder deemed to interfere with study outcomes * Smoking (currently smoking any cigarettes or using tobacco products, e-cigarettes and vapes, or ex-smokers \<3 years) * Night and rotating shift work * Travel across time zones within 4 wk of the study * History of drug or alcohol abuse or excessive alcohol consumption (\>3 drinks/day for men or 2 for women) * Recent weight change (\>5% gain or loss of body weight over past 3 months) or active participation in diet or weight loss program in previous 3 months; any weight loss procedure * Pregnancy or \<1 year post-partum * Diagnosed sleep apnea or high-risk score on Berlin questionnaire (2 or more categories with positive score) * Depression (score \>13 on Beck Depression Inventory II) or taking anti-depressive medications * Restless leg syndrome and circadian rhythm disorders * Dementia or cognitive impairments * Taking psychoactive or hypnotic medications * Taking chronic analgesic or anti-inflammatory medications * Having had gastrointestinal surgery, including gastric bypass surgery * Restrained eating or abnormal scores on the Three Factor Eating Questionnaire * Contraindications for magnetic resonance imaging scanning * Hematocrit \<30% * Taking beta blockers, as this can interfere with melatonin secretion
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Marie-Pierre St-Onge, PhD — Columbia University
- Study coordinator: Diane Hawkins
- Email: dh3078@cumc.columbia.edu
- Phone: 212 305 9379
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.