Circadian Misalignment and Energy Balance

Official title

Impact of Circadian Misalignment on Energy Balance Regulation

Overview

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.

Detailed 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.

Interventions

• Behavioral Meal times
  Meal times vary based on the arm: aligned or misaligned

Primary outcome measures

• Energy expenditure [Time frame: Change over 2-week period]
• Body composition [Time frame: Change over 4-week period]
• Nutritional intakes [Time frame: 4 weeks]

Secondary outcome measures (4)

• Task-based functional neuroimaging [Time frame: Change over 2-week period]
• Resting state functional neuroimaging [Time frame: Change over 2-week period]
• Appetite [Time frame: 4 weeks]
• Hormones [Time frame: Change over 2-week period]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Columbia University Irving Medical Center — New York

Publications

• Boege HL, Wilson KD, Kilkus JM, Qiu W, Cheng B, Wroblewski KE, Tucker B, Tasali E, St-Onge MP. Higher daytime intake of fruits and vegetables predicts less disrupted nighttime sleep in younger adults. Sleep Health. 2025 Oct;11(5):590-596. doi: 10.1016/j.sleh.2025.05.003. Epub 2025 Jun 11. PMID 40506285

Identifiers

NCT: NCT03663530 · AAAR9547

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗