ObesityRhythmNCT04009239
Time Restricted Feeding and Metabolic Rhythms
A study testing Time Restricted Feeding in people with Obesity and Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Current guidelines for the prevention and treatment of obesity focus on caloric restriction diets and increasing physical activity, but long-term compliance to these strategies is poor. Read more about this study
- Who is it for?
- Ages 20 to 50 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 8 Apr 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women with overweight and class I obesity (N=12, Age=20-50 years; BMI 25-35 kg/m2)
- Low physical activity level (≤150 min/wk of moderate-to-vigorous activity);
- For Females- Not currently pregnant or lactating and not pregnant within the past 6 months
- Habitually consume food over a window of >12 h/day;
- Pass a medical and physical screening performed by the study physician.
- Report a habitual, regular sleep-wake cycle for the month preceding screening that involved going to bed between 2200 and 0100h and getting up between 0600 and 0900 h with >7 h and <9.25 h in bed;
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- Agree to eat control diets at imposed times for 1 week prior to the inpatient CTRC visits;
- Agree to keep a regular sleep/wake schedule for the duration of the study
- Possess a smart phone to install and utilize the meal timing application.
Who cannot join
- Subjects must not be currently participating in another research study that would influence their safe participation in this study. For example, subjects must not be participating in a research study in which they ingest experimental medication, or which involves blood samples, since both of these factors could increase risk of participation;
- Being considered unsafe to participate as determined by the study physician;
- Taking medications affecting weight, triglycerides, energy intake/energy expenditure, or sleep in the last 3 months;
- Having abnormal blood chemistry and/or hematology as deemed significant by the study physician;
- o Have one or more of the following out-of-range values measured on a fasting blood sample: glucose > 126 mg/dl, HbA1c > 6.5%, thyroid stimulating hormone <0.5 or >5.0 uU/ml. Subjects who may be anemic (hemoglobin <14.5 g/dl men, <12.3 g/dl women), have abnormal liver function tests (alanine amino transferase > 47 U/l, aspartate aminotransferase, > 47 U/l, alkaline phosphatase <39 or >117 U/l) or creatinine (>1.1 mg/dl)
- Significant abnormality in clinical laboratory values
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- Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse;
- History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism;
- Score > 18 on Beck Depression Index (BDI) will require further assessment by the study physician to determine if it is appropriate for the subject to participate in the study;
- Use of a continuous positive airway pressure (CPAP) device for the treatment of obstructive sleep apnea (OSA). A score of >10 on the Epworth sleepiness scale or >5 on the Pittsburgh Sleep Quality Index will require further assessment by the study physician to determine if it is appropriate for the subject to participate in the study;
- Being positive for human immunodeficiency virus or hepatitis B or C;
- Being a smoker or having been a smoker in the previous 6 months;
- Abnormal eating patterns identified by registered dietician interview (dietary fat<15%, dietary fat>45%, dietary protein >30%);
- Working night shifts;
- Night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week);
- Traveling > 2 time zones 2 weeks prior to an inpatient CTRC study visit;
- Currently participating in any formal weight loss or physical activity programs or clinical trials.
- Having a clinically significant allergy (e.g., to food stuffs such as shellfish, peanuts);
- Celiac disease or known sensitivity to gluten (the metabolic kitchen is not gluten free certified and cannot accommodate this dietary restriction)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Current guidelines for the prevention and treatment of obesity focus on caloric restriction diets and increasing physical activity, but long-term compliance to these strategies is poor. The timing of meal intake relative to the light-dark and sleep-wake cycle is rarely considered in metabolic health; and modifying meal timing is likely easier to implement in daily life than reducing caloric intake and/or increasing physical activity. This project will test whether restricting the timing of energy intake to a short-defined period during wakefulness can be used to improve fuel utilization patterns and enhance circadian rhythms in metabolic tissues to optimize health.
Read the detailed description
Time restricted feeding (TRF; eating within <10-h period followed by >14-h fast) is a promising meal timing paradigm that in rodent studies improves multiple health indicators. When provided access to a high-fat diet ad libitum, mice rapidly gain weight. However, when fed the same diet under TRF conditions (food access restricted to an 8-h window during the active phase) mice appear to be protected from excessive weight gain and metabolic diseases. Preliminary studies in humans are showing improvements in 24-h glucose variability, fat oxidation, and blood pressure with TRF aligned to the early portion of the day compared to the ad libitum feeding schedule. A major research gap is whether the timing of the feeding window relative to sleep modifies metabolic responses. In a recent pilot and feasibility study incorporating TRF into a weight loss intervention the researchers asked participants to consume all food within a 10-h window to starting 1-h after waking for 12-weeks. The researchers' design choice was based on data showing that consuming energy in the evening is related to a two-fold increase in obesity risk. There also appears to be reduced weight loss effectiveness in dieters who consume the main meal later in the day. Some of the participants in the weight loss trial reported difficulty adhering to the early feeding schedule because it does not align well with social schedule (e.g., eating dinner with the family in the evening). Therefore, an important clinical question is whether late or mid-day TRF will result in similar metabolic benefits compared to the early TRF paradigm that has been tested in other studies.
Additional rationale for studying early vs. late timed feeding is to address a fundamental question, "can timed meals shift the timing of metabolic rhythms?". Peripheral circadian clocks located in liver, adipose, and muscle tissue are sensitive to meal timing and control daily oscillations in fuel utilization and storage. A small study of 8 men demonstrated that a 5-h delay and meal timing was sufficient to delay the rhythmic expression of clock genes in white adipose tissue. Therefore, the investigators will leverage the design of the present study to examine the impact of meal timing on peripheral circadian rhythms in metabolism and their alignment to the sleep cycle.
- Being tested
- Time Restricted Feeding
- Keywords
- Weight loss, Diet
- Medical subject headings
- Obesity, Diabetes Mellitus, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted FeedingBehavioural
Consuming energy during a short interval during the day
| Study group | Role | What they receive |
|---|---|---|
| Early Time Restricted Feeding | Experimental | Consume meals for 7 days during an 8 hour window starting 1 hour after habitual wake time. Receives: Behavioral: Time Restricted Feeding |
| Mid-day Time Restricted Feeding | Experimental | Consume meals for 7 days during an 8 hour window starting 6 hours after habitual wake time. Receives: Behavioral: Time Restricted Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fat oxidation in response to eTRF
Total fat oxidation will measured by whole room calorimetry. Early Time Restricted Feeding (eTRF) may occur at Week 1 or Week 5 depending on randomization.
Measured: Week 1 or Week 5
Total fat oxidation in response to mTRF
Total fat oxidation will measured by whole room calorimetry. Mid-day Time Restricted Feeding (mTRF) may occur at Week 1 or Week 5 depending on randomization.
Measured: Week 1 or Week 5
Insulin sensitivity in response to eTRF
Insulin sensitivity measured by three identical mixed meal tolerance tests administered across the day. Early Time Restricted Feeding (eTRF) may occur at Week 1 or Week 5 depending on randomization.
Measured: Week 1 or Week 5
Insulin sensitivity in response to mTRF
Insulin sensitivity measured by three identical mixed meal tolerance tests administered across the day. Mid-day Time Restricted Feeding (mTRF) may occur at Week 1 or Week 5 depending on randomization.
Measured: Week 1 or Week 5
Glucose control in response to eTRF
Glucose control will be measured by a continuous glucose monitor. Mid-day Time Restricted Feeding (mTRF) may occur at Week 1 or Week 5 depending on randomization.
Measured: Week 1 or Week 5
Glucose control in response to mTRF
Glucose control will be measured by a continuous glucose monitor. Early Time Restricted Feeding (eTRF) may occur at Week 1 or Week 5 depending on randomization.
Measured: Week 1 or Week 5
Secondary outcomes (9)
Difference in dietary fat oxidation between experimental conditions
Dietary fat oxidation will be measured using a stable isotope tracer
Measured: Week 1 and Week 5
Difference in 24h energy expenditure between experimental conditions
24h energy expenditure will be measured using whole room calorimetry
Measured: Week 1 and Week 5
Difference in sleep between experimental conditions
Sleep will be measured by polysomnography
Measured: Week 1 and Week 5
Difference in the melatonin rhythm between experimental conditions
The melatonin profile will be measured in plasma during constant routine protocol
Measured: Week 1 and Week 5
Difference in plasma metabolite rhythms between experimental conditions
Plasma metabolite rhythms will be measured using a constant routine protocol
Measured: Week 1 and Week 5
Difference in plasma hormone rhythms between experimental conditions
Plasma hormone rhythms will be measured using a constant routine protocol
Measured: Week 1 and Week 5
Difference in plasma gene expression rhythms between experimental conditions
Plasma gene expression rhythms will be measured using a constant routine protocol
Measured: Week 1 and Week 5
Difference in energy expenditure rhythms between experimental conditions
Energy expenditure rhythms will be measured by indirect calorimetry during a constant routine protocol
Measured: Week 1 and Week 5
Difference in substrate oxidation rhythms between experimental conditions
Substrate oxidation rhythms will be measured by indirect calorimetry during a constant routine protocol
Measured: Week 1 and Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start15 Jan 2019
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
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 ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corey A Rynders, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009239
- Sponsor's protocol ID
- 16-2754
- Other IDs
- K01DK113063
- Acronym
- Rhythm
- Status last verified
- Jul 2022
- First submitted
- 27 Jun 2019
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Feeding and Metabolic Rhythms
- ClinicalTrials.gov ID
- NCT04009239
- Acronym / sponsor ID
- Rhythm / 16-2754
- Keywords
- Weight loss, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 5 Jul 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.
Current guidelines for the prevention and treatment of obesity focus on caloric restriction diets and increasing physical activity, but long-term compliance to these strategies is poor. The timing of meal intake relative to the light-dark and sleep-wake cycle is rarely considered in metabolic health; and modifying meal timing is likely easier to implement in daily life than reducing caloric intake and/or increasing physical activity. This project will test whether restricting the timing of energy intake to a short-defined period during wakefulness can be used to improve fuel utilization patterns and enhance circadian rhythms in metabolic tissues to optimize health.
Detailed description
Time restricted feeding (TRF; eating within <10-h period followed by >14-h fast) is a promising meal timing paradigm that in rodent studies improves multiple health indicators. When provided access to a high-fat diet ad libitum, mice rapidly gain weight. However, when fed the same diet under TRF conditions (food access restricted to an 8-h window during the active phase) mice appear to be protected from excessive weight gain and metabolic diseases. Preliminary studies in humans are showing improvements in 24-h glucose variability, fat oxidation, and blood pressure with TRF aligned to the early portion of the day compared to the ad libitum feeding schedule. A major research gap is whether the timing of the feeding window relative to sleep modifies metabolic responses. In a recent pilot and feasibility study incorporating TRF into a weight loss intervention the researchers asked participants to consume all food within a 10-h window to starting 1-h after waking for 12-weeks. The researchers' design choice was based on data showing that consuming energy in the evening is related to a two-fold increase in obesity risk. There also appears to be reduced weight loss effectiveness in dieters who consume the main meal later in the day. Some of the participants in the weight loss trial reported difficulty adhering to the early feeding schedule because it does not align well with social schedule (e.g., eating dinner with the family in the evening). Therefore, an important clinical question is whether late or mid-day TRF will result in similar metabolic benefits compared to the early TRF paradigm that has been tested in other studies.
Additional rationale for studying early vs. late timed feeding is to address a fundamental question, "can timed meals shift the timing of metabolic rhythms?". Peripheral circadian clocks located in liver, adipose, and muscle tissue are sensitive to meal timing and control daily oscillations in fuel utilization and storage. A small study of 8 men demonstrated that a 5-h delay and meal timing was sufficient to delay the rhythmic expression of clock genes in white adipose tissue. Therefore, the investigators will leverage the design of the present study to examine the impact of meal timing on peripheral circadian rhythms in metabolism and their alignment to the sleep cycle.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Time Restricted Feeding | Experimental | Behavioral: Time Restricted FeedingConsume meals for 7 days during an 8 hour window starting 1 hour after habitual wake time. |
| Mid-day Time Restricted Feeding | Experimental | Behavioral: Time Restricted FeedingConsume meals for 7 days during an 8 hour window starting 6 hours after habitual wake time. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Men and women with overweight and class I obesity (N=12, Age=20-50 years; BMI 25-35 kg/m2)
- Low physical activity level (≤150 min/wk of moderate-to-vigorous activity);
- For Females- Not currently pregnant or lactating and not pregnant within the past 6 months
- Habitually consume food over a window of >12 h/day;
- Pass a medical and physical screening performed by the study physician.
Key exclusion criteria (19 listed)
- Subjects must not be currently participating in another research study that would influence their safe participation in this study. For example, subjects must not be participating in a research study in which they ingest experimental medication, or which involves blood samples, since both of these factors could increase risk of participation;
- Being considered unsafe to participate as determined by the study physician;
- Taking medications affecting weight, triglycerides, energy intake/energy expenditure, or sleep in the last 3 months;
- Having abnormal blood chemistry and/or hematology as deemed significant by the study physician;
- o Have one or more of the following out-of-range values measured on a fasting blood sample: glucose > 126 mg/dl, HbA1c > 6.5%, thyroid stimulating hormone <0.5 or >5.0 uU/ml. Subjects who may be anemic (hemoglobin <14.5 g/dl men, <12.3 g/dl women), have abnormal liver function tests (alanine amino transferase > 47 U/l, aspartate aminotransferase, > 47 U/l, alkaline phosphatase <39 or >117 U/l) or creatinine (>1.1 mg/dl)
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 FeedingConsuming energy during a short interval during the day | Behavioural | Early Time Restricted Feeding, Mid-day Time Restricted Feeding |
Primary outcome
Total fat oxidation in response to eTRF
Time frame: Week 1 or Week 5
Total fat oxidation will measured by whole room calorimetry. Early Time Restricted Feeding (eTRF) may occur at Week 1 or Week 5 depending on randomization.
Total fat oxidation in response to mTRF
Time frame: Week 1 or Week 5
Total fat oxidation will measured by whole room calorimetry. Mid-day Time Restricted Feeding (mTRF) may occur at Week 1 or Week 5 depending on randomization.
Insulin sensitivity in response to eTRF
Time frame: Week 1 or Week 5
Insulin sensitivity measured by three identical mixed meal tolerance tests administered across the day. Early Time Restricted Feeding (eTRF) may occur at Week 1 or Week 5 depending on randomization.
Insulin sensitivity in response to mTRF
Time frame: Week 1 or Week 5
Insulin sensitivity measured by three identical mixed meal tolerance tests administered across the day. Mid-day Time Restricted Feeding (mTRF) may occur at Week 1 or Week 5 depending on randomization.
Glucose control in response to eTRF
Time frame: Week 1 or Week 5
Glucose control will be measured by a continuous glucose monitor. Mid-day Time Restricted Feeding (mTRF) may occur at Week 1 or Week 5 depending on randomization.
Glucose control in response to mTRF
Time frame: Week 1 or Week 5
Glucose control will be measured by a continuous glucose monitor. Early Time Restricted Feeding (eTRF) may occur at Week 1 or Week 5 depending on randomization.
9 secondary outcomes
Difference in dietary fat oxidation between experimental conditions
Time frame: Week 1 and Week 5
Difference in 24h energy expenditure between experimental conditions
Time frame: Week 1 and Week 5
Difference in sleep between experimental conditions
Time frame: Week 1 and Week 5
Difference in the melatonin rhythm between experimental conditions
Time frame: Week 1 and Week 5
Difference in plasma metabolite rhythms between experimental conditions
Time frame: Week 1 and Week 5
Difference in plasma hormone rhythms between experimental conditions
Time frame: Week 1 and Week 5
Difference in plasma gene expression rhythms between experimental conditions
Time frame: Week 1 and Week 5
Difference in energy expenditure rhythms between experimental conditions
Time frame: Week 1 and Week 5
Difference in substrate oxidation rhythms between experimental conditions
Time frame: Week 1 and Week 5
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 14 Jul 2022.
- 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.
- 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.
Corey A Rynders, PhD principal investigator
University of Colorado, Denver
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 Colorado, Denver 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 9 inclusion and 19 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 14 Jul 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?
Total fat oxidation in response to eTRF (time frame: Week 1 or Week 5). The study lists 6 primary outcomes in all. 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 NCT04009239, 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 14 Jul 2022.