ObesityNCT05096585
Sleep Timing on Energy Intake and Energy Expenditure
A study testing Delayed bedtime sleep restriction and Early wake sleep restriction in people with Obesity, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Delayed bedtime sleep restriction and Early wake sleep restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 1 Dec 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Obesity
- Being tested
- Delayed bedtime sleep restriction, Early wake sleep restriction
- Keywords
- sleep restriction, physical activity, dietary intake, insulin resistance
- Medical subject headings
- Obesity, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed bedtime sleep restrictionBehavioural
bedtime 2 hr later than their normal bedtime
Early wake sleep restrictionBehavioural
wake time 2 hr earlier than their normal wake time
| Study group | Role | What they receive |
|---|---|---|
| normal sleep | Placebo comparator | Subjects will go to sleep at their normal bedtime and normal sleep duration (7-9 hr) Receives: Behavioral: Delayed bedtime sleep restriction; Behavioral: Early wake sleep restriction |
| delayed bedtime sleep restriction | Experimental | Subjects will go to sleep at 2 hr later than their normal bedtime Receives: Behavioral: Delayed bedtime sleep restriction; Behavioral: Early wake sleep restriction |
| early waking sleep restriction | Experimental | Subjects will wake up 2 hr earlier than their normal wake time Receives: Behavioral: Delayed bedtime sleep restriction; Behavioral: Early wake sleep restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity
physical activity (percent time in sedentary, light, moderate and vigorous PA)
Measured: 24 hours
dietary intake
macronutrient content (percent carbohydrate, fat and protein intake
Measured: 24 hours
physical activity
Step count (steps/day)
Measured: 24 hours
dietary intake
energy intake (kcals)
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Aug 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All subjects will complete 3 study conditions with a minimum of one week between each condition.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Kanaley, University of Missouri-Columbia
- Investigators
- Jill Kanaley, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096585
- Sponsor's protocol ID
- sleep timing 2016786
- Status last verified
- Mar 2023
- First submitted
- 14 Oct 2021
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Restriction and Altered Sleep Timing on Energy Intake and Energy Expenditure
- ClinicalTrials.gov ID
- NCT05096585
- Acronym / sponsor ID
- sleep timing 2016786
- Conditions
- Obesity
- Keywords
- sleep restriction, physical activity, dietary intake, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 27 Oct 2021 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All subjects will complete 3 study conditions with a minimum of one week between each condition.
| Arm | Type | Receives |
|---|---|---|
| normal sleep | Placebo comparator | Behavioral: Delayed bedtime sleep restriction, Behavioral: Early wake sleep restrictionSubjects will go to sleep at their normal bedtime and normal sleep duration (7-9 hr) |
| delayed bedtime sleep restriction | Experimental | Behavioral: Delayed bedtime sleep restriction, Behavioral: Early wake sleep restrictionSubjects will go to sleep at 2 hr later than their normal bedtime |
| early waking sleep restriction | Experimental | Behavioral: Delayed bedtime sleep restriction, Behavioral: Early wake sleep restrictionSubjects will wake up 2 hr earlier than their normal wake time |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Delayed bedtime sleep restrictionbedtime 2 hr later than their normal bedtime | Behavioural | delayed bedtime sleep restriction, early waking sleep restriction, normal sleep |
| Early wake sleep restrictionwake time 2 hr earlier than their normal wake time | Behavioural | delayed bedtime sleep restriction, early waking sleep restriction, normal sleep |
Primary outcome
physical activity
Time frame: 24 hours
physical activity (percent time in sedentary, light, moderate and vigorous PA)
dietary intake
Time frame: 24 hours
macronutrient content (percent carbohydrate, fat and protein intake
physical activity
Time frame: 24 hours
Step count (steps/day)
dietary intake
Time frame: 24 hour
energy intake (kcals)
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 10 Mar 2023.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Jill Kanaley, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed bedtime sleep restriction and Early wake sleep restriction in people with Obesity, run by University of Missouri-Columbia 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 10 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
physical activity (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2023.