PrediabetesTIMED EATINGNCT01895179
Comparison of Time-Restricted Feeding Versus Grazing
A study testing Time-Restricted Feeding and Grazing in people with Prediabetes and Insulin Resistance, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this pilot study is to find out what eating meals in a short time period early in the day (time-restricted feeding) versus eating meals spread out during the day (grazing) does to the body's ability to control blood sugar and to the health of its blood vessels. Read more about this study
- Who is it for?
- Ages 35 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Insulin Resistance, Vascular Diseases
- What is being tested?
- Time-Restricted Feeding and Grazing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 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 35 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are male
- Overweight: Have a body mass index between 25 and 50 kg/m^2 inclusive (a number calculated from height and weight)
- Are 35-70 years of age
- Have a hemoglobin A1C between 5.5 - 6.4% or prior medical indication of prediabetes
- Have a blood sugar level between 140 and 199 mg/dL two hours after drinking a sugary solution (OGTT)
- Have been eating dinner at least 8.5 hours after eating breakfast at least 90% of the time during the past year
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- Have not fasted (go for a day without any food) more than 12 days total during the past year
- Be willing to eat most meals at Pennington Biomedical and/or under supervision
- Not eat any food other than that served by Pennington Biomedical
- Not drink any alcohol, juice, or other beverages that have calories other than what is served by Pennington Biomedical
- Keep water and no-calorie drinks like tea or diet soda the same during both of the timed eating periods
- Be willing to eat your meals according to the fixed schedules
Who cannot join
- Have diabetes or are on anti-diabetes medication
- Have evidence of cardiovascular disease
- Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease
- Evidence of significant gastrointestinal issues or surgery that impacts nutrient absorption
- Regularly use medications such as steroids, beta blockers, and adrenergic-stimulating agents
- Are on any regular medicine that has not had the same dose for 1 month or longer
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- Have a clinically significant abnormality as measured by a blood test
- Regularly drink alcohol (more than 2 servings per day)
- Have to do any kind of heavy physical activity
- Currently perform overnight shift work more than one day a week
- Are not able to eat only the food served to you by Pennington Biomedical, while in the study
- Are not able to stop drinking alcohol or other drinks with calories (e.g., soda, juice) other than what is served to you by Pennington Biomedical, while in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Time-Restricted Feeding to Improve Glucose Tolerance and Vascular Condition
The purpose of this pilot study is to find out what eating meals in a short time period early in the day (time-restricted feeding) versus eating meals spread out during the day (grazing) does to the body's ability to control blood sugar and to the health of its blood vessels.
The investigators hypothesize that time-restricted feeding will be more effective at improving glucose tolerance and vascular condition (inflammation and micro- and macro-vascular function) than grazing.
Read the detailed description
Each participant will eat according to one of the two eating schedules (grazing or time-restricted feeding) for 5 weeks, have a 7-week washout period, and then eat according to the other eating schedule for 5 weeks. Measurements of glucose homeostasis and vascular condition will be performed before and after a participant follows each eating schedule.
- Conditions
- Prediabetes, Insulin Resistance, Vascular Diseases
- Being tested
- Time-Restricted Feeding, Grazing
- Keywords
- Time-restricted feeding, Intermittent fasting, Prediabetes, Insulin resistance, Glucose tolerance, Insulin sensitivity, Circadian rhythms, Diurnal
- Medical subject headings
- Prediabetic State, Insulin Resistance, Vascular Diseases, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-Restricted FeedingOther
Time-restricted feeding is a variant of intermittent fasting that involves eating all of one's calories within a few hours each day (typically 4-9 hours), followed by a daily fast of 15-20 hours.
GrazingOther
Grazing involves eating meals spread out over the course of the day.
| Study group | Role | What they receive |
|---|---|---|
| Time-Restricted Feeding (early in the day eating) | Experimental | Participants will consume all meals early in the day and within a 6-hour window. Receives: Other: Time-Restricted Feeding |
| Grazing | Placebo comparator | Participants will eat meals spread out over the course of the day. Receives: Other: Grazing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glucose Tolerance
Glucose tolerance and indices of glucose homeostasis will be determined using an Oral Glucose Tolerance Test (OGTT).
Measured: Before and after 5 weeks on each feeding schedule
Secondary outcomes (2)
Change in Vascular Function
Macro- and micro-vascular function will be assessed by Radial Artery Applanation Tonometry and by Orthogonal Polarization Spectroscopy. The endpoints measured by these two tests include aortic blood pressure, arterial stiffness, capillary density, and red blood cell velocity.
Measured: Before and after 5 weeks on each feeding schedule
Change in Inflammation and Metabolic Markers
Serum markers of inflammation, such as C-Reactive Protein (CRP) and inflammatory cytokines, and of metabolic processes will be measured (composite measure).
Measured: Before and after 5 weeks on each feeding schedule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJul 2013
- 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 (1)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney Peterson, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895179
- Sponsor's protocol ID
- PBRC 13017
- Acronym
- TIMED EATING
- Status last verified
- Mar 2018
- First submitted
- 3 Jul 2013
- Last updated
- 16 Mar 2018
- Results posted
- 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 33512717
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
- Time-Restricted Feeding to Improve Glucose Tolerance and Vascular Condition
- ClinicalTrials.gov ID
- NCT01895179
- Acronym / sponsor ID
- TIMED EATING / PBRC 13017
- Conditions
- Prediabetes, Insulin Resistance, Vascular Diseases
- Keywords
- Time-restricted feeding, Intermittent fasting, Prediabetes, Insulin resistance, Glucose tolerance, Insulin sensitivity, Circadian rhythms, Diurnal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 10 Jul 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 pilot study is to find out what eating meals in a short time period early in the day (time-restricted feeding) versus eating meals spread out during the day (grazing) does to the body's ability to control blood sugar and to the health of its blood vessels.
The investigators hypothesize that time-restricted feeding will be more effective at improving glucose tolerance and vascular condition (inflammation and micro- and macro-vascular function) than grazing.
Detailed description
Each participant will eat according to one of the two eating schedules (grazing or time-restricted feeding) for 5 weeks, have a 7-week washout period, and then eat according to the other eating schedule for 5 weeks. Measurements of glucose homeostasis and vascular condition will be performed before and after a participant follows each eating schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-Restricted Feeding (early in the day eating) | Experimental | Other: Time-Restricted FeedingParticipants will consume all meals early in the day and within a 6-hour window. |
| Grazing | Placebo comparator | Other: GrazingParticipants will eat meals spread out over the course of the day. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Are male
- Overweight: Have a body mass index between 25 and 50 kg/m^2 inclusive (a number calculated from height and weight)
- Are 35-70 years of age
- Have a hemoglobin A1C between 5.5 - 6.4% or prior medical indication of prediabetes
- Have a blood sugar level between 140 and 199 mg/dL two hours after drinking a sugary solution (OGTT)
Key exclusion criteria (12 listed)
- Have diabetes or are on anti-diabetes medication
- Have evidence of cardiovascular disease
- Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease
- Evidence of significant gastrointestinal issues or surgery that impacts nutrient absorption
- Regularly use medications such as steroids, beta blockers, and adrenergic-stimulating agents
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 |
|---|---|---|
| Time-Restricted FeedingTime-restricted feeding is a variant of intermittent fasting that involves eating all of one's calories within a few hours each day (typically 4-9 hours), followed by a daily fast of 15-20 hours. | Other | Time-Restricted Feeding (early in the day eating) |
| GrazingGrazing involves eating meals spread out over the course of the day. | Other | Grazing |
Primary outcome
Change in Glucose Tolerance
Time frame: Before and after 5 weeks on each feeding schedule
Glucose tolerance and indices of glucose homeostasis will be determined using an Oral Glucose Tolerance Test (OGTT).
2 secondary outcomes
Change in Vascular Function
Time frame: Before and after 5 weeks on each feeding schedule
Change in Inflammation and Metabolic Markers
Time frame: Before and after 5 weeks on each feeding schedule
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.
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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 Time-Restricted Feeding and Grazing in people with Prediabetes and Insulin Resistance, 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 12 inclusion and 12 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?
Change in Glucose Tolerance (time frame: Before and after 5 weeks on each feeding schedule). 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 NCT01895179, 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 16 Mar 2018.