SleepNCT01866280
Sleep Timing and Energy Balance
A study testing Normal sleep, Normal meals and Late sleep in people with Sleep and Meals, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of sleep and meal timing, independent of sleep duration, on glucose regulation and metabolic and hormonal control of energy balance in normal weight adults. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Normal sleep, Normal meals and Late sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Sep 2013
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index 22-25
- Normal scores on sleep questionnaires (PSQI, ESS, Berlin, SDIQ)
- Normal score on Beck Depression Inventory
- Intermediate chronotype on Composite Scale of Morningness/Eveningness
Who cannot join
- Neurological, medical, or psychiatric disorders
- Eating disorders
- Diabetes
- Sleep disorders
- Travel across time zones
- History of drug/alcohol abuse
Show all 9Show fewer
- Caffeine intake >300 mg/d
- Excessive daytime sleepiness
- Pregnancy or within 1 y post-partum
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's/Roosevelt Hospital
New York, New York, 10025
About this study
Official title: Effect of Sleep Timing, Independent of Duration, on Food Intake and Metabolic Control of Energy Balance
The purpose of this study is to test the effects of sleep and meal timing, independent of sleep duration, on glucose regulation and metabolic and hormonal control of energy balance in normal weight adults.
This study will be a 4-phase, randomized controlled study of 5 days each in which participants will undergo 2 phases of late sleep times that differ in meal timing (normal or late) and 2 phases of normal sleep times that differ in meal timing (normal or late).
Read more
The Aims and Hypotheses of this study are:
Aim 1: To compare hormonal regulation of food intake and metabolic risk markers in response to altered sleep and meal timing.
- Hypothesis 1: There will be an interaction between sleep and meal time on glucose, insulin, and glucose and insulin area under the curve after the glucose tolerance test such that the late sleep/late meal will result in the worst metabolic profile, normal sleep/late meal and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal will result in the best metabolic profile.
- Hypothesis 2: There will be an interaction between sleep and meal time on leptin and ghrelin concentrations such that the late sleep/late meal timing phase will result in low leptin/high ghrelin, normal sleep/late meal timing and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal timing will result in high leptin/low ghrelin.
Aim 2: To compare food intake over a 24-h period in response to altered sleep and meal timing.
- Hypothesis 3: Energy and fat intakes will be greater during the late sleep timing phase compared to normal sleep timing.
- Being tested
- Normal sleep, Normal meals, Late sleep, Late meals
- Keywords
- Sleep, Sleep duration, Meals, Food intake, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal sleepBehavioural
Normal sleep= sleep 2300-0700
Normal mealsBehavioural
Normal meal times=approximately 1.5, 5, and 11 h after wake up for breakfast, lunch, and dinner, and snack at 13 h after wake up time
Late sleepBehavioural
Late sleep=sleep at 0230-1030 hours
Late mealsBehavioural
Late meal times= approximately 4.5, 7, and 13 h after wake up time for breakfast, lunch and dinner, and snack at 15 h.
| Study group | Role | What they receive |
|---|---|---|
| Normal sleep Normal meals | Experimental | Normal sleep/Normal meal times Receives: Behavioral: Normal sleep; Behavioral: Normal meals |
| Normal sleep Late meals | Experimental | Normal sleep/Late meal times Receives: Behavioral: Normal sleep; Behavioral: Late meals |
| Late sleep Late meals | Experimental | Late sleep/Late meal times Receives: Behavioral: Late sleep; Behavioral: Late meals |
| Late sleep Normal meals | Experimental | Late sleep/Normal meal times Receives: Behavioral: Normal meals; Behavioral: Late sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Ad libitum food intake will be assessed on day 5
Measured: Single day
Oral Glucose Tolerance
Oral glucose tolerance test will be performed at scheduled breakfast time on day 4
Measured: 2 hours
Meal tolerance test
Glucose and insulin responses to a liquid meal will be assessed at scheduled lunch time
Measured: 3 hours
Secondary outcomes (1)
Hormonal profile
On day 3, the following hormones will be assessed from overnight hours: glucose, insulin, cortisol, melatonin, leptin, ghrelin, PYY, GLP-1
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866280
- Sponsor's protocol ID
- ST-01
- Status last verified
- Apr 2015
- First submitted
- 24 Apr 2013
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sleep Timing, Independent of Duration, on Food Intake and Metabolic Control of Energy Balance
- ClinicalTrials.gov ID
- NCT01866280
- Acronym / sponsor ID
- ST-01
- Keywords
- Sleep, Sleep duration, Meals, Food intake, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 31 May 2013 (estimated)
- 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.
The purpose of this study is to test the effects of sleep and meal timing, independent of sleep duration, on glucose regulation and metabolic and hormonal control of energy balance in normal weight adults.
This study will be a 4-phase, randomized controlled study of 5 days each in which participants will undergo 2 phases of late sleep times that differ in meal timing (normal or late) and 2 phases of normal sleep times that differ in meal timing (normal or late).
The Aims and Hypotheses of this study are:
Aim 1: To compare hormonal regulation of food intake and metabolic risk markers in response to altered sleep and meal timing.
- Hypothesis 1: There will be an interaction between sleep and meal time on glucose, insulin, and glucose and insulin area under the curve after the glucose tolerance test such that the late sleep/late meal will result in the worst metabolic profile, normal sleep/late meal and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal will result in the best metabolic profile.
- Hypothesis 2: There will be an interaction between sleep and meal time on leptin and ghrelin concentrations such that the late sleep/late meal timing phase will result in low leptin/high ghrelin, normal sleep/late meal timing and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal timing will result in high leptin/low ghrelin.
Aim 2: To compare food intake over a 24-h period in response to altered sleep and meal timing.
- Hypothesis 3: Energy and fat intakes will be greater during the late sleep timing phase compared to normal sleep timing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal sleep Normal meals | Experimental | Behavioral: Normal sleep, Behavioral: Normal mealsNormal sleep/Normal meal times |
| Normal sleep Late meals | Experimental | Behavioral: Normal sleep, Behavioral: Late mealsNormal sleep/Late meal times |
| Late sleep Late meals | Experimental | Behavioral: Late sleep, Behavioral: Late mealsLate sleep/Late meal times |
| Late sleep Normal meals | Experimental | Behavioral: Normal meals, Behavioral: Late sleepLate sleep/Normal meal times |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index 22-25
- Normal scores on sleep questionnaires (PSQI, ESS, Berlin, SDIQ)
- Normal score on Beck Depression Inventory
- Intermediate chronotype on Composite Scale of Morningness/Eveningness
Key exclusion criteria (9 listed)
- Neurological, medical, or psychiatric disorders
- Eating disorders
- Diabetes
- Sleep disorders
- Travel across time zones
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 |
|---|---|---|
| Normal sleepNormal sleep= sleep 2300-0700 | Behavioural | Normal sleep Late meals, Normal sleep Normal meals |
| Normal mealsNormal meal times=approximately 1.5, 5, and 11 h after wake up for breakfast, lunch, and dinner, and snack at 13 h after wake up time | Behavioural | Late sleep Normal meals, Normal sleep Normal meals |
| Late sleepLate sleep=sleep at 0230-1030 hours | Behavioural | Late sleep Late meals, Late sleep Normal meals |
| Late mealsLate meal times= approximately 4.5, 7, and 13 h after wake up time for breakfast, lunch and dinner, and snack at 15 h. | Behavioural | Late sleep Late meals, Normal sleep Late meals |
Primary outcome
Food intake
Time frame: Single day
Ad libitum food intake will be assessed on day 5
Oral Glucose Tolerance
Time frame: 2 hours
Oral glucose tolerance test will be performed at scheduled breakfast time on day 4
Meal tolerance test
Time frame: 3 hours
Glucose and insulin responses to a liquid meal will be assessed at scheduled lunch time
1 secondary outcome
Hormonal profile
Time frame: 24 hours
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 21 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal sleep, Normal meals and Late sleep in people with Sleep and Meals, run by St. Luke's-Roosevelt Hospital Center 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 4 inclusion and 9 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 21 Apr 2015. 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?
Food intake (time frame: Single day). The study lists 3 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 21 Apr 2015.