Circadian Misalignment and Energy Balance



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:20 - 49
Updated:1/16/2019
Start Date:January 1, 2019
End Date:June 30, 2023
Contact:Theresa Pizinger, MS
Email:tmp2125@cumc.columbia.edu
Phone:212-851-5583

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Impact of Circadian Misalignment on Energy Balance Regulation

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.

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.

Inclusion Criteria:

- All racial and ethnic groups

- Body mass index 25-34.9 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
We found this trial at
1
site
1150 Saint Nicholas Avenue
New York, New York 10032
Principal Investigator: Marie-Pierre St-Onge, PhD
Phone: 212-851-5583
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from
New York, NY
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