Circadian Misalignment and Energy Balance (CM)

Columbia University

Status

Enrolling

Conditions

Obesity

Treatments

Behavioral: Meal times

Study type

Interventional

Funder types

Other

Identifiers

NCT03663530

AAAR9547

Details and patient eligibility

About

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.

Full description

The proposed study will test whether the misalignment of eating occasions to the sleep period influences health markers. The goal of the proposed study is to determine whether eating out of synchrony with sleep influences risk of chronic diseases. The proposed study has both mechanistic and translational objectives. First, the investigators will test whether eating late in the day will influence energy balance (hormones, energy expenditure, nutritional intakes). Next, they will observe how misaligned meals, relative to aligned meals, influence behavior. Overweight men and women will be recruited to participate in a 2-phase, crossover study, with constant sleep periods. Phases will only differ in the alignment of meals to the sleep period: aligned = meals starting 1 h after awakening; misaligned = meals starting 5 h after awakening. Mechanistic aims will be addressed from measurements taken after 3 and 14 d of the intervention. The translational aim will be addressed after a 4 wk free-living period following the prescribed meal times for each phase. This proposed study, which will manipulate meal timing, without affecting total sleep time, is important because it will provide information on the mechanism by which circadian misalignment influences health. As such, the proposed study will be a stepping-stone in the establishment of lifestyle recommendations or therapies to personalize chronotype to reduce the risk of chronic diseases.

Enrollment

42 estimated patients

Sex

All

Ages

20 to 49 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

42 participants in 2 patient groups

Circadian misalignment

Experimental group

Description:

Meals in this condition will be delayed by 4 hours relative to the circadian alignment condition. Food intake during this period will be from 1 PM to 11 PM.

Treatment:

Behavioral: Meal times

Circadian alignment

Active Comparator group

Description:

Meals in this condition will be aligned to the sleep episode. Food intake during this period will be from 9 AM to 7 PM.

Treatment:

Behavioral: Meal times