Clinical trial NCT03257137: Diet and Sleep Monitoring
Official title: Diet and Sleep Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Diet Modification
Keywords: sleep
macronutrients
dietary patterns
sleep quality
diet quality
polysomnography
appetite
mood
hunger
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study will investigate the effect of two dietary patterns on sleep outcomes and measures of reported appetite. Participants will be given two different diets on two separate stays.

Detailed description: Normal sleep consists of alternating periods of non-rapid eye movement (NREM) and rapid eye movement (REM) sleep. The deeper stages of NREM sleep are also known as slow-wave sleep (SWS). Genetic and environmental factors, such as age, gender, race, socioeconomic status and others contribute to high inter-individual variability in sleep quality.

Current evidence from epidemiologic, clinical and experimental studies support a strong relationship between insufficient sleep and increased risk for obesity. A reciprocal connection between sleep and energy metabolism may exist between diet and sleep.

It is also well known that diet greatly influences body weight and metabolic health. Numerous disease risk factors are known to be associated with dietary patters consisting low fiber, high saturated fat, and added sugar, but the effects of diet on sleep quality remains unknown.

A small group of studies have indicated an effect of diet on sleep quality (assessed objectively by polysomnography \[PSG\]) under controlled laboratory conditions. However, none have experimentally tested sleep and appetite outcomes under different dietary patterns matched for macronutrients.

The overall objective of this study is to compare the effects of consumption of unhealthy meals with low fiber, high saturated fat, and high added sugar content i.e. simulated fast food diet \[SFF\] to healthy meals with high fiber, low saturated fat, and low added sugar content i.e. healthy diet. We hypothesize that a healthy diet (as recommended by the Dietary Guidelines Advisory Committee and the American Heart Association) compared to SFF diet will promote better sleep quality (as assessed by PSG) reflected by higher sleep efficiency, increased SWS and increased REM sleep and other improved sleep variables. We will also evaluate subjective appetite, mood and sleepiness as secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female participants (age: 21-40 years and BMI=19.0-26.0 kg/m2) who habitually sleep on average 7-8 hours per night (as confirmed by actigraphy) and eat at least 3 meals per day (as confirmed by food diaries) will be studied. Subjects will be required to have stable sleep habits for the past 6 months and stable dietary habits for the past 3 months.

Exclusion Criteria:

* Obstructive sleep apnea by laboratory polysomnography or history of any other sleep disorder, night or rotating shift work (current or in the past 1 year), habitual daytime naps, recent (\< 4 week) travel across time zones, extreme chronotypes, any acute or chronic medical condition, prediabetes or diabetes, prior or current eating or psychiatric disorders, claustrophobia, irregular menstrual periods, menopause, currently pregnant (screened with urine test), recently postpartum (within 1 year), currently lactating, alcohol abuse, excessive caffeine intake, smoking, illegal drug use, currently following a weight loss regimen or any other special diet or exercise programs, extreme food allergies or intolerances, and abnormal findings on screening blood testing. Participants will also be required not to take any prescription or over the counter medications, supplements that can affect sleep, metabolism, mood or appetite. Women will be required to not be on hormone replacement therapy.

Primary outcomes:
measure: Sleep quality night 2
timeFrame: Bedtime (11:00PM) to Wake time (7:30AM)
Secondary outcomes:
measure: Subjective appetite area under the curve
timeFrame: 7:30am-11:00PM
measure: Subjective appetite daily average
timeFrame: 7:30am-11:00PM
measure: Mood area under the curve
timeFrame: 7:30am-11:00PM
measure: Mood daily average
timeFrame: 7:30am-11:00PM
measure: Subjective sleep quality area under the curve
timeFrame: 7:30am-11:00PM
measure: Subjective sleep quality daily average
timeFrame: 7:30am-11:00PM
measure: Sleep quality night 1
timeFrame: 11:00PM to 7:30AM
measure: Sleep night 1
timeFrame: 11:00PM to 7:30AM
measure: Sleep night 2
timeFrame: 11:00PM to 7:30AM
measure: Sleep night 3
timeFrame: 11:00PM to 7:30AM
Other outcomes:
measure: Appetite upon waking
timeFrame: First response in the morning
measure: Mood upon waking
timeFrame: 7:30AM
measure: Sleepiness upon waking
timeFrame: 7:30AM
measure: Morning appetite
timeFrame: 7:30AM to 11:00AM
measure: Morning mood
timeFrame: 7:30AM to 11:00AM
measure: Morning sleepiness
timeFrame: 7:30AM to 11:00AM
measure: Mid-day appetite
timeFrame: 11:00AM to 5:00PM
measure: Mid-day mood
timeFrame: 11:00AM to 5:00PM
measure: Mid-day sleepiness
timeFrame: 11:00AM to 5:00PM
measure: Evening appetite
timeFrame: 5:00PM to 11:00PM
measure: Evening mood
timeFrame: 5:00PM to 11:00PM
measure: Evening sleepiness
timeFrame: 5:00PM to 11:00PM
measure: Bedtime appetite
timeFrame: Response at bedtime
measure: Bedtime mood
timeFrame: 11:00PM
measure: Bedtime sleepiness
timeFrame: 11:00PM
measure: Average sleep duration
timeFrame: 21 days
measure: Average sleep onset latency
timeFrame: 21 days
measure: Average night-time awakenings
timeFrame: 21 days
Locations:
city: Chicago
country: United States
facility: Univeristy of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Esra Tasali, MD
role: PRINCIPAL_INVESTIGATOR
References: