- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05096585
Sleep Timing on Energy Intake and Energy Expenditure
Sleep Restriction and Altered Sleep Timing on Energy Intake and Energy Expenditure
Studies in healthy young adults have shown that abnormal and undesirable physiological changes are a result of chronic sleep curtailment, with implications on inflammatory status, blood glucose regulation, circulating free fatty acids, and insulin sensitivity. Epidemiological studies suggest an increase in energy intake with shortened, sleep and this has been associated with weight gain. Interestingly most studies examining sleep restriction do not consider whether the restricted sleep is due to sleep delay or an advanced wake time. This study will investigate the change in physical activity or food intake during a period of sleep restriction. To date only one study has addressed this question but they only examined one study night and followed their subjects for only 24 hr. The objective of the proposed project is to examine the effects of shortened sleep on potential changes in physical activity and energy intake.
The investigators hypothesize that after several nights of short sleep that different strategies are employed to remain awake and these strategies will also vary whether bed time was delayed or wake time was advanced.
Aim 1: To examine the effects of sleep timing on energy intake and expenditure during periods of sleep restriction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects will have preliminary screening tests. There will be 3 study conditions, with the latter 2 conditions (delayed bed time/advanced wake time) will be completed in a randomized, crossover design. Subjects will wear an activity monitor (actigraph) and sleep monitor (actiwatch) for 6 days. Dietary records and smart phones will be used record energy intake.
For the first experimental condition, the subject will wear the actiwatch and actigraph, and monitor food intake for 6 day of normal sleep. This condition will allow determination of their sleep pattern and when they habitually go to bed (ie. 11 pm - 5 am) and awaken.
On the second condition, the investigators will allow subjects to maintain their usual physical activity and dietary patterns but the investigators will ask subjects to delay the time of going to bed by 2 hr. Subjects will be followed for 4 nights of shortened sleep but data will be collected for 6 days. On the other condition, subjects will go to bed at the usual time but awaken 2 hr earlier that they normally would. Again subjects will monitor their physical activity, hunger/fullness, sleep and energy intake. These latter 2 conditions will be randomized.
Visit 1: Subjects will be provided a verbal explanation of the study and will sign the informed consent if interested. Subjects will then complete questionnaires assessing health history, sleep, morningness and physical activity habits.
Visit 2: Subjects will collect physical activity monitor (actigraph) and sleep monitor (actiwatch) along with surveys to fill out each day about dietary consumption, sleep habits and physical activity, lasting for 6 days. Subjects will also be asked to photograph any food or drink they consume.
Visit 3: Return the actiwatch and actigraph.
Visit 4-5: Repeat of Visit 2-3.
Visit 6-7: Repeat of Visit 2-3.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alan Maloney, MS
- Phone Number: 573-882-4517
- Email: amzdr@mail.missouri.edu
Study Contact Backup
- Name: Becky Shafer, MS
- Phone Number: 573-882-4517
- Email: shaferrs@health.missouri.edu
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65211
- University of Misouri
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Overweight and obese men and women 21-45 years of age BMI of <40 kg/m2 normally active (>5000 steps per day) sleep: 7-9 hours per night
Exclusion Criteria:
type 1 diabetes cardiovascular disease uncontrolled hypertension smoker pregnant recent changes in hormonal birth control night shift workers take regular daytime naps operate heavy equipment Sleep less than 7 hour/night
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: normal sleep
Subjects will go to sleep at their normal bedtime and normal sleep duration (7-9 hr)
|
bedtime 2 hr later than their normal bedtime
wake time 2 hr earlier than their normal wake time
|
Experimental: delayed bedtime sleep restriction
Subjects will go to sleep at 2 hr later than their normal bedtime
|
bedtime 2 hr later than their normal bedtime
wake time 2 hr earlier than their normal wake time
|
Experimental: early waking sleep restriction
Subjects will wake up 2 hr earlier than their normal wake time
|
bedtime 2 hr later than their normal bedtime
wake time 2 hr earlier than their normal wake time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
physical activity
Time Frame: 24 hours
|
physical activity (percent time in sedentary, light, moderate and vigorous PA)
|
24 hours
|
dietary intake
Time Frame: 24 hours
|
macronutrient content (percent carbohydrate, fat and protein intake
|
24 hours
|
physical activity
Time Frame: 24 hours
|
Step count (steps/day)
|
24 hours
|
dietary intake
Time Frame: 24 hour
|
energy intake (kcals)
|
24 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- sleep timing 2016786
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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