Time Restricted FeedingNCT04000516
The Effects of Early and Late Time-Restricted Feeding on Body Composition
A study testing Time restricted feeding in people with Time Restricted Feeding, run by Texas Tech University at 1 site in United States.
Trial summary
A randomized controlled trial to determine the effectiveness of either morning or evening time-restricted feeding on body composition in sedentary, breakfast eating overweight and obese adults. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Time Restricted Feeding
- What is being tested?
- Time restricted feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 8 Apr 2019
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults that are currently habitual breakfast eaters, of overweight or obese BMI (BMI 25-35)
Who cannot join
- Participation in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months.
- Currently sedentary.
- Any highly restrictive dietary patterns.
- Currently consumes breakfast at least 5 times per week.
- Weight loss or gain of >5% of body weight in the past 6 months for any reason except post-partum weight loss.
- Currently taking medication that suppresses or stimulates appetite.
Show all 26Show fewer
- Currently taking medication that requires eating with food in the morning, including NSAIDs.
- History of prior surgical procedure for weight control or liposuction.
- Current smoker or quit smoking less than 6 months prior.
- Individuals who do resistance training two or more days per week
- Any major disease, including:
- Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
- Active or chronic infections, including self-reported HIV positivity and active tuberculosis.
- Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease (e.g., coronary artery bypass, percutaneous transluminal coronary angioplasty) in the past 6 months; New York Heart Association Functional Class >2 with respect to congestive heart failure; stroke or transient ischemic attack in the past 6 months. Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
- Active renal disease.
- Lung disease: chronic obstructive airway disease requiring use of oxygen.
- Diagnosed diabetes (type 1 or 2) .
- Uncompensated or uncontrolled psychiatric disease (such as schizophrenia and bipolar disorder) that, in opinion of the investigators, would impede conduct of the trial or completion of procedures.
- Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; another household member is a participant or staff member in the trial; unwilling to accept treatment assignment by randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating clinics before trial completed; unable to walk 0.25 mile in 10 minutes.
- Currently taking antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months.
- A recent or ongoing problem with drug abuse or addiction.
- Excessive alcohol intake, either acute or chronic, defined as any one of the following: 1) average consumption of 3 or more alcohol containing beverages daily; 2) consumption of 7 or more alcoholic beverages within a 24-hr period in the past 12 months; or 3) other evidence available to clinic staff.
- Working the "night shift" or any work schedule that would interfere with normal eating patterns.
- Not willing to be randomized to any of the three experimental conditions.
- Pregnancy and childbearing: currently pregnant or less than 3 months post partum; currently nursing or within 6 weeks of having completed nursing; pregnancy anticipated during study; unwilling to report possible or confirmed pregnancies promptly during the course of the trial; unwilling to take Qualtrics Screening Survey adequate contraceptive measures if potentially fertile.
- Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Kinesiology and Sport Managment
Lubbock, Texas, 79409
About this study
Official title: The Effects of Early and Late Time-Restricted Feeding on Body Composition: an Effectiveness Trial in Sedentary Adults With Overweight and Obesity
A randomized controlled trial to determine the effectiveness of either morning or evening time-restricted feeding on body composition in sedentary, breakfast eating overweight and obese adults. Three parallel groups were assigned to either morning fasting (MF), evening fasting (EF), or a control group and asked to do the intervention for 6 weeks. Changes in body composition (change in weight, percent body fat percent, and percent lean body mass) are the primary outcome, and hunger and satiety ratings and physical activity are secondary outcome measures.
- Conditions
- Time Restricted Feeding
- Being tested
- Time restricted feeding
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted feedingBehavioural
Restricting the eating window to about 8 hours a day, during waking hours.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group was asked to continue their usual eating schedule and pattern. |
| Evening Fasters (EF) | Experimental | Evening fasters were asked to not consume food after 3 pm until the next morning. Receives: Behavioral: Time restricted feeding |
| Morning Fasters (MF) | Experimental | Morning fasters were asked to not consume food from the time they woke until 11 am. Receives: Behavioral: Time restricted feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body fat percent
body fat percent at final visit- body fat percent at initial visit
Measured: 6 weeks
Change in percent lean mass
lean mass percent at final visit - lean mass percent at initial visit
Measured: 6 weeks
Change in body weight
body weight at final visit - body weight at initial visit
Measured: 6 weeks
Secondary outcomes (3)
Change in 24-hour physical activity energy expenditure (PAEE)
PAEE at week 3 of intervention - PAEE at baseline
Measured: change after 3 weeks of intervention
Hunger measured by Visual Analog Scale (How Hungry do you feel now?) before breaking fast Day 2
Hunger on day 2 of fasting pattern just before breaking fast, compared to hunger at that time in control group
Measured: Day 2
Hunger measured by Visual Analog Scale (How Hungry do you feel now?) before breaking fast Day 42
Hunger on Day 42 of fasting pattern just before breaking fast, compared to hunger at that time in control group
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Apr 2017
- Primary completion8 Apr 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time Restricted FeedingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Dhurandhar, Texas Tech University
- Investigators
- Emily J Dhurandhar, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000516
- Sponsor's protocol ID
- IRB2017-99
- Status last verified
- Jun 2019
- First submitted
- 19 Jun 2019
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the study are accepted for publication, de-identified data will be uploaded to the ICSPR database. The protocol will be shared as supplementary material through the journal where the study if published, if allowed.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Early and Late Time-Restricted Feeding on Body Composition: an Effectiveness Trial in Sedentary Adults With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT04000516
- Acronym / sponsor ID
- IRB2017-99
- Conditions
- Time Restricted Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 27 Jun 2019 (actual)
- 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.
A randomized controlled trial to determine the effectiveness of either morning or evening time-restricted feeding on body composition in sedentary, breakfast eating overweight and obese adults. Three parallel groups were assigned to either morning fasting (MF), evening fasting (EF), or a control group and asked to do the intervention for 6 weeks. Changes in body composition (change in weight, percent body fat percent, and percent lean body mass) are the primary outcome, and hunger and satiety ratings and physical activity are secondary outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group was asked to continue their usual eating schedule and pattern. |
| Evening Fasters (EF) | Experimental | Behavioral: Time restricted feedingEvening fasters were asked to not consume food after 3 pm until the next morning. |
| Morning Fasters (MF) | Experimental | Behavioral: Time restricted feedingMorning fasters were asked to not consume food from the time they woke until 11 am. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults that are currently habitual breakfast eaters, of overweight or obese BMI (BMI 25-35)
Key exclusion criteria (26 listed)
- Participation in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months.
- Currently sedentary.
- Any highly restrictive dietary patterns.
- Currently consumes breakfast at least 5 times per week.
- Weight loss or gain of >5% of body weight in the past 6 months for any reason except post-partum weight loss.
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 feedingRestricting the eating window to about 8 hours a day, during waking hours. | Behavioural | Evening Fasters (EF), Morning Fasters (MF) |
Primary outcome
Change in body fat percent
Time frame: 6 weeks
body fat percent at final visit- body fat percent at initial visit
Change in percent lean mass
Time frame: 6 weeks
lean mass percent at final visit - lean mass percent at initial visit
Change in body weight
Time frame: 6 weeks
body weight at final visit - body weight at initial visit
3 secondary outcomes
Change in 24-hour physical activity energy expenditure (PAEE)
Time frame: change after 3 weeks of intervention
Hunger measured by Visual Analog Scale (How Hungry do you feel now?) before breaking fast Day 2
Time frame: Day 2
Hunger measured by Visual Analog Scale (How Hungry do you feel now?) before breaking fast Day 42
Time frame: Day 42
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 27 Jun 2019.
- Individual participant dataSharing planned: Yes. Once the study are accepted for publication, de-identified data will be uploaded to the ICSPR database. The protocol will be shared as supplementary material through the journal where the study if published, if allowed.
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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.
Emily J Dhurandhar, PhD principal investigator
Texas Tech 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 Time restricted feeding in people with Time Restricted Feeding, run by Texas Tech 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 1 inclusion and 26 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 27 Jun 2019. 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?
Change in body fat percent (time frame: 6 weeks). 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 27 Jun 2019.