CClinicalTrials.gg
CompletedNCT03257137Updated Nov 22, 2022

Diet and Sleep Monitoring

An interventional study of Diet Quality in Sleep and Diet Modification, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-22.

Sponsored by University of Chicago · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
21 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sleep
  • Diet Modification

Keywords

  • sleep
  • macronutrients
  • dietary patterns
  • sleep quality
  • diet quality
  • polysomnography
  • appetite
  • mood
  • hunger
03

Who can participate

Ages eligible
21 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Healthy Diet

    This dietary pattern will represent recommendations for fiber and added sugar set forth in the 2015 Dietary Guidelines for Americans and saturated fat guidelines from the American Heart Association

    Other: Diet Quality

  • Experimental
    Simulated Fast Food (SFF)

    This dietary pattern will represent the typical American diet for fiber, added sugar, and saturated fat intake.

    Other: Diet Quality

Interventions

  • OtherDiet Quality

    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.

05

What researchers measure

Primary outcomes

  1. Sleep quality night 2

    Night 2 PSG recordings

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

Secondary outcomes

  1. Subjective appetite area under the curve

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

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

  2. Subjective appetite daily average

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

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

  3. Mood area under the curve

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

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

  4. Mood daily average

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

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

  5. Subjective sleep quality area under the curve

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

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

  6. Subjective sleep quality daily average

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

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

  7. Sleep quality night 1

    Night 2 PSG recordings

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

  8. Sleep night 1

    Measured with wrist actigraphy

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

  9. Sleep night 2

    Measured with wrist actigraphy

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

  10. Sleep night 3

    Measured with wrist actigraphy

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

Other outcomes

  1. Appetite upon waking

    First response in the morning using subjective questionnaires

    Time frame: First response in the morning

  2. Mood upon waking

    First response in the morning using subjective questionnaires

    Time frame: 7:30AM

  3. Sleepiness upon waking

    First response in the morning using subjective questionnaires

    Time frame: 7:30AM

  4. Morning appetite

    Morning hourly and pre and post meal response using subjective questionnaires

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

  5. Morning mood

    Morning hourly and pre and post meal response using subjective questionnaires

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

  6. Morning sleepiness

    Morning hourly and pre and post meal response using subjective questionnaires

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

  7. Mid-day appetite

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

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

  8. Mid-day mood

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

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

  9. Mid-day sleepiness

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

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

  10. Evening appetite

    Evening hourly and pre and post meal response using subjective questionnaires

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

  11. Evening mood

    Evening hourly and pre and post meal response using subjective questionnaires

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

  12. Evening sleepiness

    Evening hourly and pre and post meal response using subjective questionnaires

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

  13. Bedtime appetite

    Response at bedtime using subjective questionnaires

    Time frame: Response at bedtime

  14. Bedtime mood

    Response at bedtime using subjective questionnaires

    Time frame: 11:00PM

  15. Bedtime sleepiness

    Response at bedtime using subjective questionnaires

    Time frame: 11:00PM

  16. Average sleep duration

    At home wrist actigraphy

    Time frame: 21 days

  17. Average sleep onset latency

    At home wrist actigraphy

    Time frame: 21 days

  18. Average night-time awakenings

    At home wrist actigraphy

    Time frame: 21 days

06

Study locations

1 site
  • Univeristy of Chicago
    Chicago, Illinois 60637, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03257137
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Aug 22, 2017
Start date
Aug 24, 2017
Primary completion
Mar 1, 2019
Completion
Mar 29, 2019
Last update
Nov 22, 2022

Study contacts

Esra Tasali, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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