SleepNCT03257137
Diet and Sleep Monitoring
A study testing Diet Quality in people with Sleep and Diet Modification, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Diet Modification
- What is being tested?
- Diet Quality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2017to 29 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sleep, Diet Modification
- Being tested
- Diet Quality
- Keywords
- sleep, macronutrients, dietary patterns, sleep quality, diet quality, polysomnography, appetite, mood, hunger
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet QualityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Diet | Experimental | 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 Receives: Other: Diet Quality |
| Simulated Fast Food (SFF) | Experimental | This dietary pattern will represent the typical American diet for fiber, added sugar, and saturated fat intake. Receives: Other: Diet Quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality night 2
Night 2 PSG recordings
Measured: Bedtime (11:00PM) to Wake time (7:30AM)
Secondary outcomes (10)
Subjective appetite area under the curve
A collection of all subjective ratings (upon waking, pre and post meals, and hourly)
Measured: 7:30am-11:00PM
Subjective appetite daily average
A collection of all subjective ratings (upon waking, pre and post meals, and hourly)
Measured: 7:30am-11:00PM
Mood area under the curve
A collection of all subjective ratings (upon waking, pre and post meals, and hourly)
Measured: 7:30am-11:00PM
Mood daily average
A collection of all subjective ratings (upon waking, pre and post meals, and hourly)
Measured: 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)
Measured: 7:30am-11:00PM
Subjective sleep quality daily average
A collection of all subjective ratings (upon waking, pre and post meals, and hourly)
Measured: 7:30am-11:00PM
Sleep quality night 1
Night 2 PSG recordings
Measured: 11:00PM to 7:30AM
Sleep night 1
Measured with wrist actigraphy
Measured: 11:00PM to 7:30AM
Sleep night 2
Measured with wrist actigraphy
Measured: 11:00PM to 7:30AM
Sleep night 3
Measured with wrist actigraphy
Measured: 11:00PM to 7:30AM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start24 Aug 2017
- Primary completion1 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esra Tasali, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257137
- Sponsor's protocol ID
- 17-0616
- Status last verified
- Nov 2022
- First submitted
- 16 Aug 2017
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boege HL, Wilson KD, Kilkus JM, Qiu W, Cheng B, Wroblewski KE, Tucker B, Tasali E, St-Onge MP. Higher daytime intake of fruits and vegetables predicts less disrupted nighttime sleep in younger adults. Sleep Health. 2025 Oct;11(5):590-596. doi: 10.1016/j.sleh.2025.05.003. Epub 2025 Jun 11.
PubMed 40506285
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Sleep Monitoring
- ClinicalTrials.gov ID
- NCT03257137
- Acronym / sponsor ID
- 17-0616
- Conditions
- Sleep, Diet Modification
- Keywords
- sleep, macronutrients, dietary patterns, sleep quality, diet quality, polysomnography, appetite, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Diet | Experimental | Other: Diet QualityThis 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 |
| Simulated Fast Food (SFF) | Experimental | Other: Diet QualityThis dietary pattern will represent the typical American diet for fiber, added sugar, and saturated fat intake. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet QualityDiets matched for calorie intake and macronutrient distribution but differing by overall diet quality will be provided in a random order, cross-over design study. | Other | Healthy Diet, Simulated Fast Food (SFF) |
Primary outcome
Sleep quality night 2
Time frame: Bedtime (11:00PM) to Wake time (7:30AM)
Night 2 PSG recordings
10 secondary outcomes
Subjective appetite area under the curve
Time frame: 7:30am-11:00PM
Subjective appetite daily average
Time frame: 7:30am-11:00PM
Mood area under the curve
Time frame: 7:30am-11:00PM
Mood daily average
Time frame: 7:30am-11:00PM
Subjective sleep quality area under the curve
Time frame: 7:30am-11:00PM
Subjective sleep quality daily average
Time frame: 7:30am-11:00PM
Sleep quality night 1
Time frame: 11:00PM to 7:30AM
Sleep night 1
Time frame: 11:00PM to 7:30AM
Sleep night 2
Time frame: 11:00PM to 7:30AM
Sleep night 3
Time frame: 11:00PM to 7:30AM
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Derived from this study: PubMed 40506285Boege HL, Wilson KD, Kilkus JM, Qiu W, Cheng B, Wroblewski KE, Tucker B, Tasali E, St-Onge MP. Higher daytime intake of fruits and vegetables predicts less disrupted nighttime sleep in younger adults. Sleep Health. 2025 Oct;11(5):590-596. doi: 10.1016/j.sleh.2025.05.003. Epub 2025 Jun 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Tasali, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Quality in people with Sleep and Diet Modification, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality night 2 (time frame: Bedtime (11:00PM) to Wake time (7:30AM)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03257137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.