Diet and Sleep Monitoring

Sleep Clinical Trial

Official title:

Diet and Sleep Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257137
• Other study ID #: 17-0616
• Status: Completed
• Phase: N/A
• Start date: August 24, 2017
• Est. completion date: March 29, 2019

Study information

• Verified date: November 2022
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 29, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet Modification
• Sleep

Intervention

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.

Locations

Country	Name	City	State
United States	Univeristy of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Appetite upon waking	First response in the morning using subjective questionnaires	First response in the morning
Other	Mood upon waking	First response in the morning using subjective questionnaires	7:30AM
Other	Sleepiness upon waking	First response in the morning using subjective questionnaires	7:30AM
Other	Morning appetite	Morning hourly and pre and post meal response using subjective questionnaires	7:30AM to 11:00AM
Other	Morning mood	Morning hourly and pre and post meal response using subjective questionnaires	7:30AM to 11:00AM
Other	Morning sleepiness	Morning hourly and pre and post meal response using subjective questionnaires	7:30AM to 11:00AM
Other	Mid-day appetite	Mid-day hourly and pre and post meal response using subjective questionnaires	11:00AM to 5:00PM
Other	Mid-day mood	Mid-day hourly and pre and post meal response using subjective questionnaires	11:00AM to 5:00PM
Other	Mid-day sleepiness	Mid-day hourly and pre and post meal response using subjective questionnaires	11:00AM to 5:00PM
Other	Evening appetite	Evening hourly and pre and post meal response using subjective questionnaires	5:00PM to 11:00PM
Other	Evening mood	Evening hourly and pre and post meal response using subjective questionnaires	5:00PM to 11:00PM
Other	Evening sleepiness	Evening hourly and pre and post meal response using subjective questionnaires	5:00PM to 11:00PM
Other	Bedtime appetite	Response at bedtime using subjective questionnaires	Response at bedtime
Other	Bedtime mood	Response at bedtime using subjective questionnaires	11:00PM
Other	Bedtime sleepiness	Response at bedtime using subjective questionnaires	11:00PM
Other	Average sleep duration	At home wrist actigraphy	21 days
Other	Average sleep onset latency	At home wrist actigraphy	21 days
Other	Average night-time awakenings	At home wrist actigraphy	21 days
Primary	Sleep quality night 2	Night 2 PSG recordings	Bedtime (11:00PM) to Wake time (7:30AM)
Secondary	Subjective appetite area under the curve	A collection of all subjective ratings (upon waking, pre and post meals, and hourly)	7:30am-11:00PM
Secondary	Subjective appetite daily average	A collection of all subjective ratings (upon waking, pre and post meals, and hourly)	7:30am-11:00PM
Secondary	Mood area under the curve	A collection of all subjective ratings (upon waking, pre and post meals, and hourly)	7:30am-11:00PM
Secondary	Mood daily average	A collection of all subjective ratings (upon waking, pre and post meals, and hourly)	7:30am-11:00PM
Secondary	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
Secondary	Subjective sleep quality daily average	A collection of all subjective ratings (upon waking, pre and post meals, and hourly)	7:30am-11:00PM
Secondary	Sleep quality night 1	Night 2 PSG recordings	11:00PM to 7:30AM
Secondary	Sleep night 1	Measured with wrist actigraphy	11:00PM to 7:30AM
Secondary	Sleep night 2	Measured with wrist actigraphy	11:00PM to 7:30AM
Secondary	Sleep night 3	Measured with wrist actigraphy	11:00PM to 7:30AM