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.

Study Overview

• Status: Completed
• Conditions: Sleep; Diet Modification
• Intervention / Treatment: Other: Diet Quality

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Univeristy of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality night 2	Night 2 PSG recordings	Bedtime (11:00PM) to Wake time (7:30AM)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective appetite area under the curve	A collection of all subjective ratings (upon waking, pre and post meals, and hourly)	7:30am-11:00PM
Subjective appetite daily average	A collection of all subjective ratings (upon waking, pre and post meals, and hourly)	7:30am-11:00PM
Mood area under the curve	A collection of all subjective ratings (upon waking, pre and post meals, and hourly)	7:30am-11:00PM
Mood daily average	A collection of all subjective ratings (upon waking, pre and post meals, and hourly)	7:30am-11:00PM
Subjective sleep quality area under the curve	A collection of all subjective ratings (upon waking, pre and post meals, and hourly)	7:30am-11:00PM
Subjective sleep quality daily average	A collection of all subjective ratings (upon waking, pre and post meals, and hourly)	7:30am-11:00PM
Sleep quality night 1	Night 2 PSG recordings	11:00PM to 7:30AM
Sleep night 1	Measured with wrist actigraphy	11:00PM to 7:30AM
Sleep night 2	Measured with wrist actigraphy	11:00PM to 7:30AM
Sleep night 3	Measured with wrist actigraphy	11:00PM to 7:30AM

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appetite upon waking	First response in the morning using subjective questionnaires	First response in the morning
Mood upon waking	First response in the morning using subjective questionnaires	7:30AM
Sleepiness upon waking	First response in the morning using subjective questionnaires	7:30AM
Morning appetite	Morning hourly and pre and post meal response using subjective questionnaires	7:30AM to 11:00AM
Morning mood	Morning hourly and pre and post meal response using subjective questionnaires	7:30AM to 11:00AM
Morning sleepiness	Morning hourly and pre and post meal response using subjective questionnaires	7:30AM to 11:00AM
Mid-day appetite	Mid-day hourly and pre and post meal response using subjective questionnaires	11:00AM to 5:00PM
Mid-day mood	Mid-day hourly and pre and post meal response using subjective questionnaires	11:00AM to 5:00PM
Mid-day sleepiness	Mid-day hourly and pre and post meal response using subjective questionnaires	11:00AM to 5:00PM
Evening appetite	Evening hourly and pre and post meal response using subjective questionnaires	5:00PM to 11:00PM
Evening mood	Evening hourly and pre and post meal response using subjective questionnaires	5:00PM to 11:00PM
Evening sleepiness	Evening hourly and pre and post meal response using subjective questionnaires	5:00PM to 11:00PM
Bedtime appetite	Response at bedtime using subjective questionnaires	Response at bedtime
Bedtime mood	Response at bedtime using subjective questionnaires	11:00PM
Bedtime sleepiness	Response at bedtime using subjective questionnaires	11:00PM
Average sleep duration	At home wrist actigraphy	21 days
Average sleep onset latency	At home wrist actigraphy	21 days
Average night-time awakenings	At home wrist actigraphy	21 days

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 29, 2019

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: polysomnography; sleep; appetite; sleep quality; mood; hunger; dietary patterns; macronutrients; diet quality
• Other Study ID Numbers: 17-0616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No