NCT03257137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

August 24, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2019

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

1.5 years

First QC Date

August 16, 2017

Last Update Submit

November 18, 2022

Conditions

SleepDiet Modification

Keywords

sleepmacronutrientsdietary patternssleep qualitydiet qualitypolysomnographyappetitemoodhunger

Outcome Measures

Primary Outcomes (1)

  • Sleep quality night 2

    Night 2 PSG recordings

    Bedtime (11:00PM) to Wake time (7:30AM)

Secondary Outcomes (10)

  • Subjective appetite area under the curve

    7:30am-11:00PM

  • Subjective appetite daily average

    7:30am-11:00PM

  • Mood area under the curve

    7:30am-11:00PM

  • Mood daily average

    7:30am-11:00PM

  • Subjective sleep quality area under the curve

    7:30am-11:00PM

  • +5 more secondary outcomes

Other Outcomes (18)

  • Appetite upon waking

    First response in the morning

  • Mood upon waking

    7:30AM

  • Sleepiness upon waking

    7:30AM

  • +15 more other outcomes

Study Arms (2)

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

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.

Other: Diet Quality

Interventions

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.

Healthy DietSimulated Fast Food (SFF)

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • 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.

    PMID: 40506285DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Esra Tasali, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 22, 2017

Study Start

August 24, 2017

Primary Completion

March 1, 2019

Study Completion

March 29, 2019

Last Updated

November 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)