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Diet and Sleep Monitoring

Diet and Sleep Monitoring

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03257137
Enrollment
5
Registered
2017-08-22
Start date
2017-08-24
Completion date
2019-03-29
Last updated
2022-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Modification, Sleep

Keywords

sleep, macronutrients, dietary patterns, sleep quality, diet quality, polysomnography, appetite, mood, hunger

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.

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.

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.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, 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

Eligibility

Sex/Gender
ALL
Age
21 Years to 40 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Sleep quality night 2Bedtime (11:00PM) to Wake time (7:30AM)Night 2 PSG recordings

Secondary

MeasureTime frameDescription
Subjective appetite daily average7:30am-11:00PMA collection of all subjective ratings (upon waking, pre and post meals, and hourly)
Mood area under the curve7:30am-11:00PMA collection of all subjective ratings (upon waking, pre and post meals, and hourly)
Mood daily average7:30am-11:00PMA collection of all subjective ratings (upon waking, pre and post meals, and hourly)
Subjective sleep quality area under the curve7:30am-11:00PMA collection of all subjective ratings (upon waking, pre and post meals, and hourly)
Subjective appetite area under the curve7:30am-11:00PMA collection of all subjective ratings (upon waking, pre and post meals, and hourly)
Sleep quality night 111:00PM to 7:30AMNight 2 PSG recordings
Sleep night 111:00PM to 7:30AMMeasured with wrist actigraphy
Sleep night 211:00PM to 7:30AMMeasured with wrist actigraphy
Sleep night 311:00PM to 7:30AMMeasured with wrist actigraphy
Subjective sleep quality daily average7:30am-11:00PMA collection of all subjective ratings (upon waking, pre and post meals, and hourly)

Other

MeasureTime frameDescription
Evening sleepiness5:00PM to 11:00PMEvening hourly and pre and post meal response using subjective questionnaires
Bedtime appetiteResponse at bedtimeResponse at bedtime using subjective questionnaires
Bedtime mood11:00PMResponse at bedtime using subjective questionnaires
Appetite upon wakingFirst response in the morningFirst response in the morning using subjective questionnaires
Average sleep duration21 daysAt home wrist actigraphy
Average sleep onset latency21 daysAt home wrist actigraphy
Average night-time awakenings21 daysAt home wrist actigraphy
Bedtime sleepiness11:00PMResponse at bedtime using subjective questionnaires
Mood upon waking7:30AMFirst response in the morning using subjective questionnaires
Sleepiness upon waking7:30AMFirst response in the morning using subjective questionnaires
Morning appetite7:30AM to 11:00AMMorning hourly and pre and post meal response using subjective questionnaires
Morning mood7:30AM to 11:00AMMorning hourly and pre and post meal response using subjective questionnaires
Morning sleepiness7:30AM to 11:00AMMorning hourly and pre and post meal response using subjective questionnaires
Mid-day appetite11:00AM to 5:00PMMid-day hourly and pre and post meal response using subjective questionnaires
Mid-day mood11:00AM to 5:00PMMid-day hourly and pre and post meal response using subjective questionnaires
Mid-day sleepiness11:00AM to 5:00PMMid-day hourly and pre and post meal response using subjective questionnaires
Evening appetite5:00PM to 11:00PMEvening hourly and pre and post meal response using subjective questionnaires
Evening mood5:00PM to 11:00PMEvening hourly and pre and post meal response using subjective questionnaires

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026