ObesityNCT03867773
Time Restricted Feeding (4-hour Versus 6-hour) for Weight Loss in Obese Adults
A study testing Time restricted feeding in people with Obesity and Diabetes, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The aims of this proposal are to compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight and metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- 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
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 30 Oct 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female;
- body mass index (BMI) between 30.0 and 49.9 kg/m2;
- age between 18 and 65 years; sedentary (light exercise less than 1 h per week) or moderately active (moderate exercise 1 to 2 h per week);
- weight stable for >3 months prior to the beginning of the study (gain or loss <4 kg);
- able to give written informed consent
Who cannot join
- Smoker; diabetic;
- taking weight loss medications;
- taking medication that requires eating food before (or with) the medication; history of eating disorders;
- night-shift workers;
- perimenopausal;
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60612
About this study
The aims of this proposal are to compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight and metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF.
Read the detailed description
Modest weight loss of 5-10% is sufficient to reduce metabolic disease risk in obese individuals. The first line of therapy prescribed for weight loss is daily calorie restriction (CR; 25% restriction every day). However, adherence to CR greatly diminishes after 4-6 weeks, due to subject frustration with constantly having to count calories and never being able to eat freely. In light of these issues with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This strategy is termed time restricted feeding (TRF), and involves confining the period of food intake to 8 h/d (10 am to 6 pm) without calorie counting. Preliminary findings of 8-h TRF demonstrate modest weight loss and blood pressure reductions after 12 weeks. What remains unknown however, is whether shorter feeding windows during TRF (such as 4-h or 6-h feeding windows) can produce even greater weight loss in obese adults. Also of interest, is the impact of these shorter feeding windows on metabolic disease risk indicators (such as plasma lipids, blood pressure, and insulin resistance, inflammation and oxidative stress). Accordingly, the aims of this proposal are: AIM 1: To compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight in adults with obesity; AIM 2: To compare the effects of 4-h versus 6-h TRF on metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF on body weight and metabolic disease risk markers.
- Being tested
- Time restricted feeding
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted feedingBehavioural
TRF subjects will consume food ad libitum during the feeding window (4-h or 6-h window), and refrain from eating during the fasting window (20-h or 18-h window)
| Study group | Role | What they receive |
|---|---|---|
| 4-hour Time restricted feeding | Experimental | 4-h TRF subjects will consume food ad libitum between 3pm and 7pm (4-h feeding window), and refrain from eating and drinking caloric beverages from 7pm to 3pm (20-h fasting window) each day. These subjects will not be instructed to limit/monitor energy intake during the feeding window. Subjects will be encouraged to drink plenty of water during the fasting period. Receives: Behavioral: Time restricted feeding |
| Control | No intervention | Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits. Controls will visit the research center at the same frequency as the TRF groups (for outcome measurements). |
| 6-hour Time restricted feeding | Experimental | 6-h TRF subjects will consume food ad libitum between 1pm and 7pm (6-h feeding window), and refrain from eating and drinking caloric beverages from 7pm to 1pm (18-h fasting window) each day. These subjects will not be instructed to limit/monitor energy intake during the feeding window. Subjects will be encouraged to drink plenty of water during the fasting period. Receives: Behavioral: Time restricted feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 8 in body weight
Measured by an electronic scale
Measured: Measured at week 1 and 8
Secondary outcomes (17)
Change from baseline to week 8 in body composition
Measured by DXA
Measured: Measured at week 1 and 8
Change from baseline to week 8 in Insulin resistance
Measured as HOMA-IR
Measured: Measured at week 1 and 8
Change from baseline to week 8 in Fasting glucose
Measured with a hexokinase reagent kit
Measured: Measured at week 1 and 8
Change from baseline to week 8 in Fasting insulin
Measured as total immunoreactive insulin
Measured: Measured at week 1 and 8
Change from baseline to week 8 in Blood pressure
Measured by a blood pressure cuff
Measured: Measured at week 1 and 8
Change from baseline to week 8 in adverse events
Measured by questionnaire
Measured: Measured weekly from baseline to week 8
Change from baseline to week 8 in plasma lipids
Measured by outside lab (Medstart, IN)
Measured: Measured at week 1 and 8
Change from baseline to week 8 in heart rate
Measured by a blood pressure cuff
Measured: Measured at week 1 and 8
Change from baseline to week 8 in inflammatory markers (TNF-a, IL-6)
Measured by ELISA
Measured: Measured at week 1 and 8
Change from baseline to week 8 in oxidative stress (8-isoprostane)
Measured by ELISA
Measured: Measured at week 1 and 8
Change from baseline to week 8 in calorie and macronutrient intake
Measured by food record
Measured: Measured at week 1 and 8
Change from baseline to week 8 in physical activity (steps/d)
Measured by activity monitor
Measured: Measured at week 1 and 8
Change from baseline to week 8 in diet adherence
Measured by a questionnaire
Measured: Measured weekly from baseline to week 8
Change from baseline to week 8 in sleep quality
Measured by a questionnaire
Measured: Measured at week 1 and 8
Change from baseline to week 8 in insomnia severity
Measured by a questionnaire
Measured: Measured at week 1 and 8
Change from baseline to week 8 in risk of sleep apnea
Measured by a questionnaire
Measured: Measured at week 1 and 8
Change from baseline to week 8 in sex steroid levels (estrogen, androgens, sex hormone binding globulin)
Measured by a ELISA
Measured: Measured at week 1 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start1 Feb 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
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 ObesityStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krista Varady, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867773
- Sponsor's protocol ID
- 2018-1525
- Status last verified
- Jun 2022
- First submitted
- 4 Mar 2019
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cienfuegos S, Gabel K, Kalam F, Ezpeleta M, Lin S, Varady KA. Changes in body weight and metabolic risk during time restricted feeding in premenopausal versus postmenopausal women. Exp Gerontol. 2021 Oct 15;154:111545. doi: 10.1016/j.exger.2021.111545. Epub 2021 Aug 31.
PubMed 34478825Cienfuegos S, Gabel K, Kalam F, Ezpeleta M, Wiseman E, Pavlou V, Lin S, Oliveira ML, Varady KA. Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. Cell Metab. 2020 Sep 1;32(3):366-378.e3. doi: 10.1016/j.cmet.2020.06.018. Epub 2020 Jul 15.
PubMed 32673591
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Feeding (4-hour Versus 6-hour) for Weight Loss in Obese Adults
- ClinicalTrials.gov ID
- NCT03867773
- Acronym / sponsor ID
- 2018-1525
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 8 Mar 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.
The aims of this proposal are to compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight and metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF.
Detailed description
Modest weight loss of 5-10% is sufficient to reduce metabolic disease risk in obese individuals. The first line of therapy prescribed for weight loss is daily calorie restriction (CR; 25% restriction every day). However, adherence to CR greatly diminishes after 4-6 weeks, due to subject frustration with constantly having to count calories and never being able to eat freely. In light of these issues with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This strategy is termed time restricted feeding (TRF), and involves confining the period of food intake to 8 h/d (10 am to 6 pm) without calorie counting. Preliminary findings of 8-h TRF demonstrate modest weight loss and blood pressure reductions after 12 weeks. What remains unknown however, is whether shorter feeding windows during TRF (such as 4-h or 6-h feeding windows) can produce even greater weight loss in obese adults. Also of interest, is the impact of these shorter feeding windows on metabolic disease risk indicators (such as plasma lipids, blood pressure, and insulin resistance, inflammation and oxidative stress). Accordingly, the aims of this proposal are: AIM 1: To compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight in adults with obesity; AIM 2: To compare the effects of 4-h versus 6-h TRF on metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF on body weight and metabolic disease risk markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4-hour Time restricted feeding | Experimental | Behavioral: Time restricted feeding4-h TRF subjects will consume food ad libitum between 3pm and 7pm (4-h feeding window), and refrain from eating and drinking caloric beverages from 7pm to 3pm (20-h fasting window) each day. These subjects will not be instructed to limit/monitor energy intake during the feeding window. Subjects will be encouraged to drink plenty of water during the fasting period. |
| Control | No intervention | –Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits. Controls will visit the research center at the same frequency as the TRF groups (for outcome measurements). |
| 6-hour Time restricted feeding | Experimental | Behavioral: Time restricted feeding6-h TRF subjects will consume food ad libitum between 1pm and 7pm (6-h feeding window), and refrain from eating and drinking caloric beverages from 7pm to 1pm (18-h fasting window) each day. These subjects will not be instructed to limit/monitor energy intake during the feeding window. Subjects will be encouraged to drink plenty of water during the fasting period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female;
- body mass index (BMI) between 30.0 and 49.9 kg/m2;
- age between 18 and 65 years; sedentary (light exercise less than 1 h per week) or moderately active (moderate exercise 1 to 2 h per week);
- weight stable for >3 months prior to the beginning of the study (gain or loss <4 kg);
- able to give written informed consent
Key exclusion criteria (6 listed)
- Smoker; diabetic;
- taking weight loss medications;
- taking medication that requires eating food before (or with) the medication; history of eating disorders;
- night-shift workers;
- perimenopausal;
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 feedingTRF subjects will consume food ad libitum during the feeding window (4-h or 6-h window), and refrain from eating during the fasting window (20-h or 18-h window) | Behavioural | 4-hour Time restricted feeding, 6-hour Time restricted feeding |
Primary outcome
Change from baseline to week 8 in body weight
Time frame: Measured at week 1 and 8
Measured by an electronic scale
17 secondary outcomes
Change from baseline to week 8 in body composition
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in Insulin resistance
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in Fasting glucose
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in Fasting insulin
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in Blood pressure
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in adverse events
Time frame: Measured weekly from baseline to week 8
Change from baseline to week 8 in plasma lipids
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in heart rate
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in inflammatory markers (TNF-a, IL-6)
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in oxidative stress (8-isoprostane)
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in calorie and macronutrient intake
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in physical activity (steps/d)
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in diet adherence
Time frame: Measured weekly from baseline to week 8
Change from baseline to week 8 in sleep quality
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in insomnia severity
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in risk of sleep apnea
Time frame: Measured at week 1 and 8
Change from baseline to week 8 in sex steroid levels (estrogen, androgens, sex hormone binding globulin)
Time frame: Measured at week 1 and 8
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 24 Jun 2022.
- Derived from this study: PubMed 34478825Cienfuegos S, Gabel K, Kalam F, Ezpeleta M, Lin S, Varady KA. Changes in body weight and metabolic risk during time restricted feeding in premenopausal versus postmenopausal women. Exp Gerontol. 2021 Oct 15;154:111545. doi: 10.1016/j.exger.2021.111545. Epub 2021 Aug 31.
- Derived from this study: PubMed 32673591Cienfuegos S, Gabel K, Kalam F, Ezpeleta M, Wiseman E, Pavlou V, Lin S, Oliveira ML, Varady KA. Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. Cell Metab. 2020 Sep 1;32(3):366-378.e3. doi: 10.1016/j.cmet.2020.06.018. Epub 2020 Jul 15.
- Individual participant dataSharing planned: No
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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 in people with Obesity and Diabetes, run by University of Illinois Chicago 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 5 inclusion and 6 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 24 Jun 2022. 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 from baseline to week 8 in body weight (time frame: Measured at week 1 and 8). 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 NCT03867773, 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 24 Jun 2022.