ObesityNCT02347020
Impact of Sleep and Meal Timing on Food Intake Regulation
A study testing Normal Sleep/ Normal Meal, Normal Sleep/ Late Meal and Late Sleep/ Normal Meal in people with Obesity and Diabetes Mellitus, Type II, run by Columbia University at 1 site in United States.
Trial summary
This study will test the hypothesis that a late sleep (Ls) and/or late meal (Lm) behavioral pattern, with equal sleep duration, will promote positive energy balance and insulin resistance (IR). Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type II, Cardiovascular Disease
- What is being tested?
- Normal Sleep/ Normal Meal, Normal Sleep/ Late Meal and Late Sleep/ Normal Meal
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jan 2016
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants free of any current and past sleep and psychiatric disorders, including eating disorders (ex.anorexia, bulimia, night eating syndrome)
- Participants will not have diabetes and will normally consume a meal within 1 h after awakening at least 5 times/wk
- Participants with normal scores on the Pittsburgh Quality of Sleep Questionnaire [78] (global score <5) and Epworth Sleepiness Scale [79] (score <10), no indication of sleep apnea (Berlin Questionnaire) [80], sleep disorders (Sleep Disorders Inventory Questionnaire) [81], depression (Beck Depression Inventory II) [82], significant delayed or advanced sleep phase (Composite Scale of Morningness/Eveningness) [83], and involuntary sleep movement, by self-report.
Who cannot join
- Smokers (smoking any cigarettes or ex-smokers <3 y)
- Non-day and rotating shift workers
- Persons who plan to travel across time zones within 4 wk of the study
- Persons with a history of drug and alcohol abuse, drowsy driving, or excessive caffeine intake (>300 mg/d)
- Persons with recent weight change or who actively participated in a diet or weight loss program in the previous 3 mo.
- Individuals with a neurologic condition that may disrupt the procedures will be excluded
- Persons with low hematocrit (<30%) due to the high blood sampling protocol *Women who are pregnant or <1 y post-partum
- Individuals with contraindications for fMRI
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Nutrition Obesity Research Center
New York, New York, 10032
About this study
This study will test the hypothesis that a late sleep (Ls) and/or late meal (Lm) behavioral pattern, with equal sleep duration, will promote positive energy balance and insulin resistance (IR).
Read the detailed description
Sleeping patterns affect aspects of metabolism that may impact obesity risk; our lab is interested in studying whether sleep patterns play a role in the development of obesity. Individuals with late bedtimes and late rise times tend to have greater food intake which includes more fast food and sugar-sweetened beverages, less fruits and vegetables [1], larger portions, and later eating times [2] than those with earlier bedtimes. This sleeping pattern is highly prevalent: ~15 million Americans work on shifts other than regular day hours [3] and others subject themselves to 'social jetlag' (time difference between the middle of the sleep episode [midpoint of sleep] on work days and non-work days, similar to travel across time zones) [4]. The shift in sleep and meal times associated with these lifestyles results in misalignment of sleep and eating behaviors with the circadian clocks. These clocks, located in the brain and organs throughout the body, regulate metabolism and behavior and are affected by sleep and feeding. Disruption of clock genes in individual organs may be in part responsible for metabolic dysregulation [5]. Altering the coordination of sleep and meal timing may affect food reward valuation (brain) and metabolism (peripheral organs) to promote obesity and IR, observed more frequently in shift workers. This is the focus of this randomized, crossover, controlled study of 4 phases:
- Normal sleep (Ns; 0000-0800 h), Normal meals (Nm=meals at 1, 5, 11, and 12.5 h after awakening)=Ns/Nm
- Normal sleep (Ns; 0000-0800 h), Late meals (Lm=meals at 4.5, 8.5, 14.5, and 16 h after awakening)=Ns/Lm
- Late sleep (Ls; 0330-1130 h), Normal meals (Nm=meals at 1, 5, 11, and 12.5 h after awakening)=Ls/Nm
- Late sleep (Ls; 0330-1130 h), Late meals (Lm=meals at 4.5, 8.5, 14.5, and 16 h after awakening)=Ls/Lm Aim 1: To determine whether Ls and/or Lm, in individuals with habitual normal sleep duration and timing, alters one or both sides of energy balance, i.e. food intake and energy expenditure (EE), relative to Ns and Nm.
- Hypothesis 1: (a) Ls and Lm will have independent and interactive effects on food intake and EE. Intake at an ad libitum test meal and during a 24 h period, measured after 3 d of each intervention, will be greater during Ls and Lm, and this will be enhanced when Ls and Lm are combined, compared to Ns and Nm. (b) Resting metabolic rate (RMR) will be lower during the Ls and Lm phases, and this will be further reduced when Ls and Lm are combined compared to the Ns and Nm phases (Ns/Nm<Ls/Nm≤Ns/Lm<Ls/Lm).
Aim 2: To determine whether neuronal responses to food stimuli in brain regions related to reward value explain differences in food intake.
- Hypothesis 2: (a) Increased brain activity in response to visual presentation of food stimuli, using functional magnetic resonance imaging (fMRI), will be seen in Ls and Lm compared to Ns and Nm in the insula and the orbitofrontal cortex. Enhanced neuronal activity in response to foods will be most pronounced in the Ls/Lm phase (Ns/Nm<Ls/Nm≤Ns/Lm<Ls/Lm). (b) Neuronal responses to food stimuli will be related to pre-test neuropeptide Y (NPY), hypocretin-1, and subsequent food intake.
Exploratory Aim 3: To determine whether meal or sleep timing affect glucose homeostasis and appetite-regulating hormones.
- Hypothesis 3: Ls and Lm will result in lower insulin sensitivity (frequently sampled i.v. glucose tolerance test [FSIVGTT] and meal tolerance test [MTT]) than Ns and Nm (Ns/Nm>Ls/Nm≥Ns/Lm>Ls/Lm). Sleep and meal timing will have independent and interactive effects on the 24-h pattern of hormones regulating food intake (lower leptin and glucagon-like peptide-1 [GLP-1]; higher ghrelin, NPY and hypocretin-1).
- Conditions
- Obesity, Diabetes Mellitus, Type II, Cardiovascular Disease
- Being tested
- Normal Sleep/ Normal Meal, Normal Sleep/ Late Meal, Late Sleep/ Normal Meal, Late Sleep/ Late Meal
- Keywords
- Obesity, Metabolic Disorders
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Sleep/ Normal MealBehavioural
The subject will be inpatient for 5 days, and sleep between the hours of 0000-0800 h, with meals at 1, 5, 11, and 12.5 (snack) h after awakening every day for 5 days. On night 3, we will insert a catheter in the participant's arm to facilitate multiple blood sampling overnight and the next day. On d 4, a frequently sampled i.v. glucose tolerance test (FSIVGTT) will be performed. A MTT will be performed at the scheduled lunch. At 1 h before dinner, participants will undergo fMRI scanning to assess neuronal responses to food stimuli and to examine functional connectivity with reward circuitry. On d 5, participants will be allowed to determine their own food intake at the scheduled meal and snack times. Participants will be discharged upon awakening on day 6.
Normal Sleep/ Late MealBehavioural
The subject will be inpatient for 5 days and sleep between the hours of 0000-0800 h,with controlled meals at 4.5, 8.5, 14.5, and 16 (snack) h after awakening. On night 3, we will insert a catheter in the participant's arm to facilitate multiple blood sampling overnight and the next day. On d 4, at the scheduled breakfast time, a frequently sampled i.v. glucose tolerance test (FSIVGTT) will be performed. A MTT will be performed at the scheduled lunch. At 1 h before dinner, participants will undergo fMRI scanning to assess neuronal responses to food stimuli and to examine functional connectivity with reward circuitry. On d 5, participants will be allowed to determine their own food intake at the scheduled meal and snack times. Participants will be discharged upon awakening on day 6.
Late Sleep/ Normal MealBehavioural
The subject will be inpatient for 5 days, and sleep between the hours of 0330-1130 h, with controlled meals at 1, 5, 11, and 12.5 (snack) h after awakening. On night 3, we will insert a catheter in the participant's arm to facilitate multiple blood sampling overnight and the next day. On d 4, at the scheduled breakfast time, a frequently sampled i.v. glucose tolerance test (FSIVGTT) will be performed. A MTT will be performed at the scheduled lunch. At 1 h before dinner, participants will undergo fMRI scanning to assess neuronal responses to food stimuli and to examine functional connectivity with reward circuitry. On d 5, participants will be allowed to determine their own food intake at the scheduled meal and snack times. Participants will be discharged upon awakening on day 6.
Late Sleep/ Late MealBehavioural
The subject will be inpatient for 5 days, and sleep between the hours o 0330-1130 h, with controlled meals at 4.5, 8.5, 14.5, and 16 (snack) h after awakening. On night 3, we will insert a catheter in the participant's arm to facilitate multiple blood sampling overnight and the next day. On d 4, at the scheduled breakfast time, a frequently sampled i.v. glucose tolerance test (FSIVGTT) will be performed. A MTT will be performed at the scheduled lunch. At 1 h before dinner, participants will undergo fMRI scanning to assess neuronal responses to food stimuli and to examine functional connectivity with reward circuitry. On d 5, participants will be allowed to determine their own food intake at the scheduled meal and snack times. Participants will be discharged upon awakening on day 6.
| Study group | Role | What they receive |
|---|---|---|
| Normal Sleep/ Normal Meal | Experimental | sleep 0000-0800 h, meals at 1, 5, 11, and 12.5 (snack) h after awakening Receives: Behavioral: Normal Sleep/ Normal Meal |
| Normal Sleep/ Late Meal | Experimental | Ns/Lm: sleep 0000-0800 h, meals at 4.5, 8.5, 14.5, and 16 (snack) h after awakening Receives: Behavioral: Normal Sleep/ Late Meal |
| Late Sleep/ Normal Meal | Experimental | sleep 0330-1130 h, meals at 1, 5, 11, and 12.5 (snack) h after awakening Receives: Behavioral: Late Sleep/ Normal Meal |
| Late Sleep/ Late Meal | Experimental | sleep 0330-1130 h, meals at 4.5, 8.5, 14.5, and 16 (snack) h after awakening Receives: Behavioral: Late Sleep/ Late Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Intake
Energy, fat, protein, carbohydrate, sugar, fiber intakes by weighed intake measures
Measured: 24 h
Secondary outcomes (2)
Neuronal response
fMRI assessment of neuronal responses to food vs non-food stimuli and during the resting state
Measured: 1 h
Cardio-metabolic risk profile
Frequently sampled i.v. glucose tolerance test; meal tolerance test (glucose and insulin) pattern of hormones regulating food intake (lower leptin and GLP-1; higher ghrelin, NPY and hypocretin-1
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionJan 2016
- Study completionJan 2016
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 Columbia UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, Columbia University
- Investigators
- Marie-Pierre St-Onge, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347020
- Sponsor's protocol ID
- AAAO1801
- Other IDs
- 1R56HL119945
- Status last verified
- May 2016
- First submitted
- 16 Jan 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep and Meal Timing on Food Intake Regulation
- ClinicalTrials.gov ID
- NCT02347020
- Acronym / sponsor ID
- AAAO1801
- Conditions
- Obesity, Diabetes Mellitus, Type II, Cardiovascular Disease
- Keywords
- Obesity, Metabolic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Jan 2015 (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.
This study will test the hypothesis that a late sleep (Ls) and/or late meal (Lm) behavioral pattern, with equal sleep duration, will promote positive energy balance and insulin resistance (IR).
Detailed description
Sleeping patterns affect aspects of metabolism that may impact obesity risk; our lab is interested in studying whether sleep patterns play a role in the development of obesity. Individuals with late bedtimes and late rise times tend to have greater food intake which includes more fast food and sugar-sweetened beverages, less fruits and vegetables [1], larger portions, and later eating times [2] than those with earlier bedtimes. This sleeping pattern is highly prevalent: ~15 million Americans work on shifts other than regular day hours [3] and others subject themselves to 'social jetlag' (time difference between the middle of the sleep episode [midpoint of sleep] on work days and non-work days, similar to travel across time zones) [4]. The shift in sleep and meal times associated with these lifestyles results in misalignment of sleep and eating behaviors with the circadian clocks. These clocks, located in the brain and organs throughout the body, regulate metabolism and behavior and are affected by sleep and feeding. Disruption of clock genes in individual organs may be in part responsible for metabolic dysregulation [5]. Altering the coordination of sleep and meal timing may affect food reward valuation (brain) and metabolism (peripheral organs) to promote obesity and IR, observed more frequently in shift workers. This is the focus of this randomized, crossover, controlled study of 4 phases:
- Normal sleep (Ns; 0000-0800 h), Normal meals (Nm=meals at 1, 5, 11, and 12.5 h after awakening)=Ns/Nm
- Normal sleep (Ns; 0000-0800 h), Late meals (Lm=meals at 4.5, 8.5, 14.5, and 16 h after awakening)=Ns/Lm
- Late sleep (Ls; 0330-1130 h), Normal meals (Nm=meals at 1, 5, 11, and 12.5 h after awakening)=Ls/Nm
- Late sleep (Ls; 0330-1130 h), Late meals (Lm=meals at 4.5, 8.5, 14.5, and 16 h after awakening)=Ls/Lm Aim 1: To determine whether Ls and/or Lm, in individuals with habitual normal sleep duration and timing, alters one or both sides of energy balance, i.e. food intake and energy expenditure (EE), relative to Ns and Nm.
- Hypothesis 1: (a) Ls and Lm will have independent and interactive effects on food intake and EE. Intake at an ad libitum test meal and during a 24 h period, measured after 3 d of each intervention, will be greater during Ls and Lm, and this will be enhanced when Ls and Lm are combined, compared to Ns and Nm. (b) Resting metabolic rate (RMR) will be lower during the Ls and Lm phases, and this will be further reduced when Ls and Lm are combined compared to the Ns and Nm phases (Ns/Nm<Ls/Nm≤Ns/Lm<Ls/Lm).
Aim 2: To determine whether neuronal responses to food stimuli in brain regions related to reward value explain differences in food intake.
- Hypothesis 2: (a) Increased brain activity in response to visual presentation of food stimuli, using functional magnetic resonance imaging (fMRI), will be seen in Ls and Lm compared to Ns and Nm in the insula and the orbitofrontal cortex. Enhanced neuronal activity in response to foods will be most pronounced in the Ls/Lm phase (Ns/Nm<Ls/Nm≤Ns/Lm<Ls/Lm). (b) Neuronal responses to food stimuli will be related to pre-test neuropeptide Y (NPY), hypocretin-1, and subsequent food intake.
Exploratory Aim 3: To determine whether meal or sleep timing affect glucose homeostasis and appetite-regulating hormones.
- Hypothesis 3: Ls and Lm will result in lower insulin sensitivity (frequently sampled i.v. glucose tolerance test [FSIVGTT] and meal tolerance test [MTT]) than Ns and Nm (Ns/Nm>Ls/Nm≥Ns/Lm>Ls/Lm). Sleep and meal timing will have independent and interactive effects on the 24-h pattern of hormones regulating food intake (lower leptin and glucagon-like peptide-1 [GLP-1]; higher ghrelin, NPY and hypocretin-1).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Sleep/ Normal Meal | Experimental | Behavioral: Normal Sleep/ Normal Mealsleep 0000-0800 h, meals at 1, 5, 11, and 12.5 (snack) h after awakening |
| Normal Sleep/ Late Meal | Experimental | Behavioral: Normal Sleep/ Late MealNs/Lm: sleep 0000-0800 h, meals at 4.5, 8.5, 14.5, and 16 (snack) h after awakening |
| Late Sleep/ Normal Meal | Experimental | Behavioral: Late Sleep/ Normal Mealsleep 0330-1130 h, meals at 1, 5, 11, and 12.5 (snack) h after awakening |
| Late Sleep/ Late Meal | Experimental | Behavioral: Late Sleep/ Late Mealsleep 0330-1130 h, meals at 4.5, 8.5, 14.5, and 16 (snack) h after awakening |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants free of any current and past sleep and psychiatric disorders, including eating disorders (ex.anorexia, bulimia, night eating syndrome)
- Participants will not have diabetes and will normally consume a meal within 1 h after awakening at least 5 times/wk
- Participants with normal scores on the Pittsburgh Quality of Sleep Questionnaire [78] (global score <5) and Epworth Sleepiness Scale [79] (score <10), no indication of sleep apnea (Berlin Questionnaire) [80], sleep disorders (Sleep Disorders Inventory Questionnaire) [81], depression (Beck Depression Inventory II) [82], significant delayed or advanced sleep phase (Composite Scale of Morningness/Eveningness) [83], and involuntary sleep movement, by self-report.
Key exclusion criteria (8 listed)
- Smokers (smoking any cigarettes or ex-smokers <3 y)
- Non-day and rotating shift workers
- Persons who plan to travel across time zones within 4 wk of the study
- Persons with a history of drug and alcohol abuse, drowsy driving, or excessive caffeine intake (>300 mg/d)
- Persons with recent weight change or who actively participated in a diet or weight loss program in the previous 3 mo.
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 Sleep/ Normal MealThe subject will be inpatient for 5 days, and sleep between the hours of 0000-0800 h, with meals at 1, 5, 11, and 12.5 (snack) h after awakening every day for 5 days. On night 3, we will insert a catheter in the participant's arm to facilitate multiple blood sampling overnight and the next day. On d 4, a frequently sampled i.v. glucose tolerance test (FSIVGTT) will be performed. A MTT will be performed at the scheduled lunch. At 1 h before dinner, participants will undergo fMRI scanning to assess neuronal responses to food stimuli and to examine functional connectivity with reward circuitry. On d 5, participants will be allowed to determine their own food intake at the scheduled meal and snack times. Participants will be discharged upon awakening on day 6. | Behavioural | Normal Sleep/ Normal Meal |
| Normal Sleep/ Late MealThe subject will be inpatient for 5 days and sleep between the hours of 0000-0800 h,with controlled meals at 4.5, 8.5, 14.5, and 16 (snack) h after awakening. On night 3, we will insert a catheter in the participant's arm to facilitate multiple blood sampling overnight and the next day. On d 4, at the scheduled breakfast time, a frequently sampled i.v. glucose tolerance test (FSIVGTT) will be performed. A MTT will be performed at the scheduled lunch. At 1 h before dinner, participants will undergo fMRI scanning to assess neuronal responses to food stimuli and to examine functional connectivity with reward circuitry. On d 5, participants will be allowed to determine their own food intake at the scheduled meal and snack times. Participants will be discharged upon awakening on day 6. | Behavioural | Normal Sleep/ Late Meal |
| Late Sleep/ Normal MealThe subject will be inpatient for 5 days, and sleep between the hours of 0330-1130 h, with controlled meals at 1, 5, 11, and 12.5 (snack) h after awakening. On night 3, we will insert a catheter in the participant's arm to facilitate multiple blood sampling overnight and the next day. On d 4, at the scheduled breakfast time, a frequently sampled i.v. glucose tolerance test (FSIVGTT) will be performed. A MTT will be performed at the scheduled lunch. At 1 h before dinner, participants will undergo fMRI scanning to assess neuronal responses to food stimuli and to examine functional connectivity with reward circuitry. On d 5, participants will be allowed to determine their own food intake at the scheduled meal and snack times. Participants will be discharged upon awakening on day 6. | Behavioural | Late Sleep/ Normal Meal |
| Late Sleep/ Late MealThe subject will be inpatient for 5 days, and sleep between the hours o 0330-1130 h, with controlled meals at 4.5, 8.5, 14.5, and 16 (snack) h after awakening. On night 3, we will insert a catheter in the participant's arm to facilitate multiple blood sampling overnight and the next day. On d 4, at the scheduled breakfast time, a frequently sampled i.v. glucose tolerance test (FSIVGTT) will be performed. A MTT will be performed at the scheduled lunch. At 1 h before dinner, participants will undergo fMRI scanning to assess neuronal responses to food stimuli and to examine functional connectivity with reward circuitry. On d 5, participants will be allowed to determine their own food intake at the scheduled meal and snack times. Participants will be discharged upon awakening on day 6. | Behavioural | Late Sleep/ Late Meal |
Primary outcome
Food Intake
Time frame: 24 h
Energy, fat, protein, carbohydrate, sugar, fiber intakes by weighed intake measures
2 secondary outcomes
Neuronal response
Time frame: 1 h
Cardio-metabolic risk profile
Time frame: 1 day
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 12 May 2016.
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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
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 Normal Sleep/ Normal Meal, Normal Sleep/ Late Meal and Late Sleep/ Normal Meal in people with Obesity and Diabetes Mellitus, Type II, run by Columbia University 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 3 inclusion and 8 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 12 May 2016. 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: 24 h). 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 12 May 2016.