Circadian Misalignment and Energy Balance

Официальное название

Impact of Circadian Misalignment on Energy Balance Regulation

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• <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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Columbia University Irving Medical Center — New York

Публикации

• 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

Идентификаторы

NCT: NCT03663530 · AAAR9547

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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