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OpenTrials
Completed

NCT Number: NCT03257137

Diet and Sleep Monitoring

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.

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Key information

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet Quality

Other

Diets matched for calorie intake and macronutrient distribution but differing by overall diet quality will be provided in a random order, cross-over design study.

Primary outcomes

  1. Sleep quality night 2

    Time frame: Bedtime (11:00PM) to Wake time (7:30AM)

    Night 2 PSG recordings

Secondary outcomes

  1. Subjective appetite area under the curve

    Time frame: 7:30am-11:00PM

    A collection of all subjective ratings (upon waking, pre and post meals, and hourly)

  2. Subjective appetite daily average

    Time frame: 7:30am-11:00PM

    A collection of all subjective ratings (upon waking, pre and post meals, and hourly)

  3. Mood area under the curve

    Time frame: 7:30am-11:00PM

    A collection of all subjective ratings (upon waking, pre and post meals, and hourly)

  4. Mood daily average

    Time frame: 7:30am-11:00PM

    A collection of all subjective ratings (upon waking, pre and post meals, and hourly)

  5. Subjective sleep quality area under the curve

    Time frame: 7:30am-11:00PM

    A collection of all subjective ratings (upon waking, pre and post meals, and hourly)

  6. Subjective sleep quality daily average

    Time frame: 7:30am-11:00PM

    A collection of all subjective ratings (upon waking, pre and post meals, and hourly)

  7. Sleep quality night 1

    Time frame: 11:00PM to 7:30AM

    Night 2 PSG recordings

  8. Sleep night 1

    Time frame: 11:00PM to 7:30AM

    Measured with wrist actigraphy

  9. Sleep night 2

    Time frame: 11:00PM to 7:30AM

    Measured with wrist actigraphy

  10. Sleep night 3

    Time frame: 11:00PM to 7:30AM

    Measured with wrist actigraphy

Other outcomes

  1. Appetite upon waking

    Time frame: First response in the morning

    First response in the morning using subjective questionnaires

  2. Mood upon waking

    Time frame: 7:30AM

    First response in the morning using subjective questionnaires

  3. Sleepiness upon waking

    Time frame: 7:30AM

    First response in the morning using subjective questionnaires

  4. Morning appetite

    Time frame: 7:30AM to 11:00AM

    Morning hourly and pre and post meal response using subjective questionnaires

  5. Morning mood

    Time frame: 7:30AM to 11:00AM

    Morning hourly and pre and post meal response using subjective questionnaires

  6. Morning sleepiness

    Time frame: 7:30AM to 11:00AM

    Morning hourly and pre and post meal response using subjective questionnaires

  7. Mid-day appetite

    Time frame: 11:00AM to 5:00PM

    Mid-day hourly and pre and post meal response using subjective questionnaires

  8. Mid-day mood

    Time frame: 11:00AM to 5:00PM

    Mid-day hourly and pre and post meal response using subjective questionnaires

  9. Mid-day sleepiness

    Time frame: 11:00AM to 5:00PM

    Mid-day hourly and pre and post meal response using subjective questionnaires

  10. Evening appetite

    Time frame: 5:00PM to 11:00PM

    Evening hourly and pre and post meal response using subjective questionnaires

  11. Evening mood

    Time frame: 5:00PM to 11:00PM

    Evening hourly and pre and post meal response using subjective questionnaires

  12. Evening sleepiness

    Time frame: 5:00PM to 11:00PM

    Evening hourly and pre and post meal response using subjective questionnaires

  13. Bedtime appetite

    Time frame: Response at bedtime

    Response at bedtime using subjective questionnaires

  14. Bedtime mood

    Time frame: 11:00PM

    Response at bedtime using subjective questionnaires

  15. Bedtime sleepiness

    Time frame: 11:00PM

    Response at bedtime using subjective questionnaires

  16. Average sleep duration

    Time frame: 21 days

    At home wrist actigraphy

  17. Average sleep onset latency

    Time frame: 21 days

    At home wrist actigraphy

  18. Average night-time awakenings

    Time frame: 21 days

    At home wrist actigraphy

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2017
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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