Diet and Sleep Monitoring

Sponsor
University of Chicago (Other)
Overall Status
Unknown status
CT.gov ID
NCT03257137
Collaborator
(none)
12
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Diet Quality
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants will undergo both diet pattern conditions but not be informed of their differences. The technologist scoring the sleep studies and actiwatches will be blinded to the condition
Primary Purpose:
Other
Official Title:
Diet and Sleep Monitoring
Actual Study Start Date :
Aug 24, 2017
Actual Primary Completion Date :
Mar 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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
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.

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
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.

Outcome Measures

Primary Outcome Measures

  1. Sleep quality night 2 [Bedtime (11:00PM) to Wake time (7:30AM)]

    Night 2 PSG recordings

Secondary Outcome Measures

  1. Subjective appetite area under the curve [7:30am-11:00PM]

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

  2. Subjective appetite daily average [7:30am-11:00PM]

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

  3. Mood area under the curve [7:30am-11:00PM]

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

  4. Mood daily average [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 [7:30am-11:00PM]

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

  6. Subjective sleep quality daily average [7:30am-11:00PM]

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

  7. Sleep quality night 1 [11:00PM to 7:30AM]

    Night 2 PSG recordings

  8. Sleep night 1 [11:00PM to 7:30AM]

    Measured with wrist actigraphy

  9. Sleep night 2 [11:00PM to 7:30AM]

    Measured with wrist actigraphy

  10. Sleep night 3 [11:00PM to 7:30AM]

    Measured with wrist actigraphy

Other Outcome Measures

  1. Appetite upon waking [First response in the morning]

    First response in the morning using subjective questionnaires

  2. Mood upon waking [7:30AM]

    First response in the morning using subjective questionnaires

  3. Sleepiness upon waking [7:30AM]

    First response in the morning using subjective questionnaires

  4. Morning appetite [7:30AM to 11:00AM]

    Morning hourly and pre and post meal response using subjective questionnaires

  5. Morning mood [7:30AM to 11:00AM]

    Morning hourly and pre and post meal response using subjective questionnaires

  6. Morning sleepiness [7:30AM to 11:00AM]

    Morning hourly and pre and post meal response using subjective questionnaires

  7. Mid-day appetite [11:00AM to 5:00PM]

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

  8. Mid-day mood [11:00AM to 5:00PM]

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

  9. Mid-day sleepiness [11:00AM to 5:00PM]

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

  10. Evening appetite [5:00PM to 11:00PM]

    Evening hourly and pre and post meal response using subjective questionnaires

  11. Evening mood [5:00PM to 11:00PM]

    Evening hourly and pre and post meal response using subjective questionnaires

  12. Evening sleepiness [5:00PM to 11:00PM]

    Evening hourly and pre and post meal response using subjective questionnaires

  13. Bedtime appetite [Response at bedtime]

    Response at bedtime using subjective questionnaires

  14. Bedtime mood [11:00PM]

    Response at bedtime using subjective questionnaires

  15. Bedtime sleepiness [11:00PM]

    Response at bedtime using subjective questionnaires

  16. Average sleep duration [21 days]

    At home wrist actigraphy

  17. Average sleep onset latency [21 days]

    At home wrist actigraphy

  18. Average night-time awakenings [21 days]

    At home wrist actigraphy

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 40 Years
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Univeristy of Chicago Chicago Illinois United States 60637

Sponsors and Collaborators

  • University of Chicago

Investigators

  • Principal Investigator: Esra Tasali, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT03257137
Other Study ID Numbers:
  • 17-0616
First Posted:
Aug 22, 2017
Last Update Posted:
Aug 12, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Chicago

Study Results

No Results Posted as of Aug 12, 2019