ObesityNCT01751581
Sleep Restriction and Energy Expenditure
A study testing Short Sleep and Habitual sleep in people with Obesity, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
Each 4-day period will follow the same protocol. Basically, for the entire study, we will prepare all of the subject's food and will require him or her to eat all of the food that we give at the times we tell them to eat. The subject will arrive at the hospital on the evening of day 1, and become inpatients. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Short Sleep and Habitual sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Apr 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 21-45 yrs
- Non-pregnant, non-lactating female subjects
- Body mass index (BMI) 25-28 kg/m2
- Weight stable (± 2.5 kg) for at least 3 mo prior to evaluation
- If a woman of child-bearing potential, must be willing to adhere to an acceptable form of contraception
- Non-smoker
- Regularly sleeps 7-8.5 hours/night
- If taking any form of medication, other than those listed in the exclusion criteria, must have been stable and remain on the same medication and medication dose throughout the study
Who cannot join
- Diabetes, uncontrolled hypertension
- Attempted to lose weight in past 3 months
- Eating disorder
- Stroke, seizure disorder, or other significant neurological disease;
- HIV positive by self-report
- Unstable or uncontrolled medical illness including active malignancies within past 5 yrs
Show all 17Show fewer
- Untreated or unstable hypothyroidism
- Hyperthyroidism
- A score on the Brief Psychiatric Inventory that exceeds the 90th percentile;
- Subjects with psychoses, bipolar disorder, major depression, severe personality disorders, suicidal
- Alcohol or substance abuse in the past 6 mo
- Pregnant, planning pregnancy in the next 6 mo, or breast-feeding
- Participating in a commercial diet or behavior modification program (e.g., Weight Watchers), or plans to participate
- Shift worker, commercial long-distance driver, heavy equipment operator, history of drowsy driving
- Takes naps regularly
- Has traveled across time zones in the past 4 weeks or plans to during the weeks of the study
- Excessive caffeine intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sleep Reduction on Daily Energy Expenditure, Thermic Effect of Food, and Substrate Oxidation in Overweight Women
Each 4-day period will follow the same protocol. Basically, for the entire study, we will prepare all of the subject's food and will require him or her to eat all of the food that we give at the times we tell them to eat. The subject will arrive at the hospital on the evening of day 1, and become inpatients. On day 2, the subject will be permitted to leave the hospital campus under the supervision of the research staff. On day 3, they will be required to stay in a small room called a metabolic chamber for 24 hours. This room measures how many calories you burn in one day. On day 4, we will measure the subject's energy expenditure in response to a breakfast meal. They will be given breakfast and the number of calories that they burn after that meal will be measured over a 6-hour period. Then the subject will be discharged at the end of the test. The 2 study periods will differ only in bedtimes and wakeup times. During one period, the subject will go to bed at 1 am and wake up at 5 am and during the other period they will go to bed at 11 pm and wake up at 7 am.
Read the detailed description
Sleeping metabolic rate will be measured using a metabolic chamber on the night of day 2. During day 3, 24-hour energy expenditure (including a second night of measurement) will be measured in the metabolic chamber. On this day, the participant will perform 2 bouts of physical activity on a stationary bicycle for 15 minutes each bout. This will give us a measurement of physical activity energy expenditure. On day 4, at 7 am, the participant will exit the metabolic chamber and will enter a different, smaller metabolic chamber for the measurement of energy expenditure in response to a meal. This measurement will start at approximately 8 am with assessment of the resting metabolic rate (45 minutes). The participant will then be given a high-fat meal replacement to consume over 10 minutes. Energy expenditure measurements continue in the metabolic chamber for a 6-hour period.
- Conditions
- Obesity
- Being tested
- Short Sleep, Habitual sleep
- Keywords
- Obesity, Resting Metabolic Rate, Sleep, Eating
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short SleepBehavioural
Participants will be restricted in sleep and only allowed to sleep from 1 am to 5 am.
Habitual sleepBehavioural
Participants sleep 8 h/night throughout the study phase (from 11 pm to 7 am)
| Study group | Role | What they receive |
|---|---|---|
| Habitual Sleep | Active comparator | Women sleep 8 h/night throughout the study phase Receives: Behavioral: Habitual sleep |
| Short Sleep | Experimental | Women sleep 4 h/night throughout the study phase Receives: Behavioral: Short Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Metabolic Rate
Metabolic rate from 11 pm on day 2 until 7 am on the morning of day 4 will be measured in a metabolic chamber. The metabolic chamber is an air-tight room (22,000 l volume) equipped with a bed, chair, desk, television, VCR, telephone, treadmill, sink and toilet. All meals and snacks will be served at the scheduled time. Subjects will be asked to perform 30 min of light physical activity at 1500 h and 2030 h. Physical activity will consist of 30 min of cycling at 12 mi/h. Bedtimes will be the same as the previous night and actigraph monitoring will be used to confirm compliance with the sleep protocol. Women will exit the chamber at 0700 h the following day.
Measured: 32 hours
Secondary outcomes (1)
Post Prandial Energy Expenditure and Thermic Effect of Food
Energy expenditure will be measured from 8 am until approximately 2:30 pm on day. Resting metabolic rate over 45 minutes will be measured at 8 am, followed by breakfast and resumption of energy expenditure measurements postprandially.
Participants will be given 15 min to consume a high-fat breakfast (50% of energy from fat) and post-prandial thermogenesis and substrate oxidation will be measured for the next 6 h.
Measured: 8 hours on day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionApr 2013
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 ObesityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Pierre St. Onge, PhD, Principal investigator, St. Luke's Roosevelt Hospital/Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751581
- Sponsor's protocol ID
- SLR-P&F-1
- Status last verified
- Dec 2011
- First submitted
- 6 Jun 2012
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Shechter A, Rising R, Albu JB, St-Onge MP. Experimental sleep curtailment causes wake-dependent increases in 24-h energy expenditure as measured by whole-room indirect calorimetry. Am J Clin Nutr. 2013 Dec;98(6):1433-9. doi: 10.3945/ajcn.113.069427. Epub 2013 Oct 2.
PubMed 24088722
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep Reduction on Daily Energy Expenditure, Thermic Effect of Food, and Substrate Oxidation in Overweight Women
- ClinicalTrials.gov ID
- NCT01751581
- Acronym / sponsor ID
- SLR-P&F-1
- Conditions
- Obesity
- Keywords
- Obesity, Resting Metabolic Rate, Sleep, Eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Dec 2012 (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.
Each 4-day period will follow the same protocol. Basically, for the entire study, we will prepare all of the subject's food and will require him or her to eat all of the food that we give at the times we tell them to eat. The subject will arrive at the hospital on the evening of day 1, and become inpatients. On day 2, the subject will be permitted to leave the hospital campus under the supervision of the research staff. On day 3, they will be required to stay in a small room called a metabolic chamber for 24 hours. This room measures how many calories you burn in one day. On day 4, we will measure the subject's energy expenditure in response to a breakfast meal. They will be given breakfast and the number of calories that they burn after that meal will be measured over a 6-hour period. Then the subject will be discharged at the end of the test. The 2 study periods will differ only in bedtimes and wakeup times. During one period, the subject will go to bed at 1 am and wake up at 5 am and during the other period they will go to bed at 11 pm and wake up at 7 am.
Detailed description
Sleeping metabolic rate will be measured using a metabolic chamber on the night of day 2. During day 3, 24-hour energy expenditure (including a second night of measurement) will be measured in the metabolic chamber. On this day, the participant will perform 2 bouts of physical activity on a stationary bicycle for 15 minutes each bout. This will give us a measurement of physical activity energy expenditure. On day 4, at 7 am, the participant will exit the metabolic chamber and will enter a different, smaller metabolic chamber for the measurement of energy expenditure in response to a meal. This measurement will start at approximately 8 am with assessment of the resting metabolic rate (45 minutes). The participant will then be given a high-fat meal replacement to consume over 10 minutes. Energy expenditure measurements continue in the metabolic chamber for a 6-hour period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Habitual Sleep | Active comparator | Behavioral: Habitual sleepWomen sleep 8 h/night throughout the study phase |
| Short Sleep | Experimental | Behavioral: Short SleepWomen sleep 4 h/night throughout the study phase |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 21-45 yrs
- Non-pregnant, non-lactating female subjects
- Body mass index (BMI) 25-28 kg/m2
- Weight stable (± 2.5 kg) for at least 3 mo prior to evaluation
- If a woman of child-bearing potential, must be willing to adhere to an acceptable form of contraception
Key exclusion criteria (17 listed)
- Diabetes, uncontrolled hypertension
- Attempted to lose weight in past 3 months
- Eating disorder
- Stroke, seizure disorder, or other significant neurological disease;
- HIV positive by self-report
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 |
|---|---|---|
| Short SleepParticipants will be restricted in sleep and only allowed to sleep from 1 am to 5 am. | Behavioural | Short Sleep |
| Habitual sleepParticipants sleep 8 h/night throughout the study phase (from 11 pm to 7 am) | Behavioural | Habitual Sleep |
Primary outcome
Resting Metabolic Rate
Time frame: 32 hours
Metabolic rate from 11 pm on day 2 until 7 am on the morning of day 4 will be measured in a metabolic chamber. The metabolic chamber is an air-tight room (22,000 l volume) equipped with a bed, chair, desk, television, VCR, telephone, treadmill, sink and toilet. All meals and snacks will be served at the scheduled time. Subjects will be asked to perform 30 min of light physical activity at 1500 h and 2030 h. Physical activity will consist of 30 min of cycling at 12 mi/h. Bedtimes will be the same as the previous night and actigraph monitoring will be used to confirm compliance with the sleep protocol. Women will exit the chamber at 0700 h the following day.
1 secondary outcome
Post Prandial Energy Expenditure and Thermic Effect of Food
Time frame: 8 hours on day 4
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 2 Aug 2013.
- Derived from this study: PubMed 24088722Shechter A, Rising R, Albu JB, St-Onge MP. Experimental sleep curtailment causes wake-dependent increases in 24-h energy expenditure as measured by whole-room indirect calorimetry. Am J Clin Nutr. 2013 Dec;98(6):1433-9. doi: 10.3945/ajcn.113.069427. Epub 2013 Oct 2.
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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.
Marie-Pierre St. Onge, PhD principal investigator
St. Luke's Roosevelt Hospital/Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Sleep and Habitual sleep in people with Obesity, 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 8 inclusion and 17 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 2 Aug 2013. 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?
Resting Metabolic Rate (time frame: 32 hours). 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 NCT01751581, 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 2 Aug 2013.