Meal TimingGRAZINGNCT02247076
Does Meal Timing Affect Energy Expenditure
A study testing Grazing and Time-restricted feeding (early eating) in people with Meal Timing, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to find out if meal timing affects calories burned and blood sugar levels. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Meal Timing
- What is being tested?
- Grazing and Time-restricted feeding (early eating)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2017
- 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
- Are 20-45 years of age
- Have a weight between 150 and 220 lbs
- Have a body mass index between 25 and 35 kg/m2 inclusive (a number calculated from your height and weight)
- If you are a female, have a regular menstrual cycle that is between 25 and 35 days long
- If you are female, had your period within the last 35 days
- Regularly go to sleep between 9:30 pm and 12:00 am
- Regularly eat dinner 9 or more hours after eating breakfast
- Are willing to have about 2/3 cup of your blood stored for future research related to this study
Who cannot join
- Have diabetes or are on anti-diabetes medication
- Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease
- Have stomach or intestinal problems
- Regularly use medications such as steroids, beta blockers, adrenergic-stimulating agents, and laxatives
- Take any medications or supplements known to affect sleep, circadian rhythms, or metabolism (with the exception that certain forms of birth control are allowed)
- Have abnormal lab work that is clinically significant in the opinion of the study physician
Show all 21Show fewer
- Are pregnant or lactating
- Take the Depo Provera shot, or use an Interuterine Device (IUD) or hormone patch for birth control
- If you are on hormonal birth control, have been on a stable dose for less than 3 months
- Have smoked or used nicotine/tobacco products within the last 3 months
- Regularly do competitive sport training
- Perform overnight shift work an average of one or more times per week
- Have an irregular sleep schedule
- Have an irregular eating schedule
- Regularly drink 3 or more drinks of alcohol per day
- Are not able or are unwilling to eat only the food and drink served to you by Pennington Biomedical, while in the study
- Are not able or are unwilling to refrain from strenuous exercise while participating in the study
- Are not able to spend 2 separate full days (for about 25 hours each) at Pennington Biomedical
- Are not able to maintain a consistent sleep schedule while participating in the study
- Are not able to maintain a consistent eating schedule while participating in the study
- Are not able to stop drinking coffee and other caffeine-containing drinks on the day of and day prior to testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
The purpose of this study is to find out if meal timing affects calories burned and blood sugar levels.
Read the detailed description
10 overweight adult men and women will eat according to two different eating schedules: grazing and time-restricting feeding ("early eating"). While on each eating schedule, metabolism (calories burned) will be measured during a 24-hour stay in a respiratory chamber. Glucose levels-as well as key diurnal rhythms such in heart rate-will also be measured continuously. This study requires two 1-week periods of participation.
- Conditions
- Meal Timing
- Being tested
- Grazing, Time-restricted feeding (early eating)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrazingBehavioural
Time-restricted feeding (early eating)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Grazing | Placebo comparator | Participants will eat meals spread over the course of the day ("grazing"). Receives: Behavioral: Grazing |
| Time-restricted feeding (early eating) | Experimental | Participants will eat meals only in the early part of the day (early lunch and very early dinner). Receives: Behavioral: Time-restricted feeding (early eating) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure (calories burned)
Measured: 2 days
Secondary outcomes (1)
Blood sugar levels
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Meal TimingStudies 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Obesity Society
- Responsible party
- Principal investigator, Courtney Peterson, Pennington Biomedical Research Center
- Investigators
- Courtney M Peterson, PhD, MSc, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247076
- Sponsor's protocol ID
- PBRC 2014-038
- Acronym
- GRAZING
- Status last verified
- Mar 2018
- First submitted
- 19 Sep 2014
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PubMed 33512717Ravussin E, Beyl RA, Poggiogalle E, Hsia DS, Peterson CM. Early Time-Restricted Feeding Reduces Appetite and Increases Fat Oxidation But Does Not Affect Energy Expenditure in Humans. Obesity (Silver Spring). 2019 Aug;27(8):1244-1254. doi: 10.1002/oby.22518.
PubMed 31339000
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Meal Timing Affect Energy Expenditure
- ClinicalTrials.gov ID
- NCT02247076
- Acronym / sponsor ID
- GRAZING / PBRC 2014-038
- Conditions
- Meal Timing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- The Obesity Society
- Study start
- Oct 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 23 Sep 2014 (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 find out if meal timing affects calories burned and blood sugar levels.
Detailed description
10 overweight adult men and women will eat according to two different eating schedules: grazing and time-restricting feeding ("early eating"). While on each eating schedule, metabolism (calories burned) will be measured during a 24-hour stay in a respiratory chamber. Glucose levels-as well as key diurnal rhythms such in heart rate-will also be measured continuously. This study requires two 1-week periods of participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grazing | Placebo comparator | Behavioral: GrazingParticipants will eat meals spread over the course of the day ("grazing"). |
| Time-restricted feeding (early eating) | Experimental | Behavioral: Time-restricted feeding (early eating)Participants will eat meals only in the early part of the day (early lunch and very early dinner). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Are 20-45 years of age
- Have a weight between 150 and 220 lbs
- Have a body mass index between 25 and 35 kg/m2 inclusive (a number calculated from your height and weight)
- If you are a female, have a regular menstrual cycle that is between 25 and 35 days long
- If you are female, had your period within the last 35 days
Key exclusion criteria (21 listed)
- Have diabetes or are on anti-diabetes medication
- Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease
- Have stomach or intestinal problems
- Regularly use medications such as steroids, beta blockers, adrenergic-stimulating agents, and laxatives
- Take any medications or supplements known to affect sleep, circadian rhythms, or metabolism (with the exception that certain forms of birth control are allowed)
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 |
|---|---|---|
| Grazing | Behavioural | Grazing |
| Time-restricted feeding (early eating) | Behavioural | Time-restricted feeding (early eating) |
Primary outcome
Energy expenditure (calories burned)
Time frame: 2 days
1 secondary outcome
Blood sugar levels
Time frame: 2 days
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 16 Mar 2018.
- Derived from this study: PubMed 33512717Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
- Derived from this study: PubMed 31339000Ravussin E, Beyl RA, Poggiogalle E, Hsia DS, Peterson CM. Early Time-Restricted Feeding Reduces Appetite and Increases Fat Oxidation But Does Not Affect Energy Expenditure in Humans. Obesity (Silver Spring). 2019 Aug;27(8):1244-1254. doi: 10.1002/oby.22518.
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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.
Courtney M Peterson, PhD, MSc principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grazing and Time-restricted feeding (early eating) in people with Meal Timing, run by Pennington Biomedical Research 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 21 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 16 Mar 2018. 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?
Energy expenditure (calories burned) (time frame: 2 days). 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 NCT02247076, which also lists 2 linked publications.
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 16 Mar 2018.