| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obesity Diabetes | Behavioral: Time Restricted Feeding | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 12 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Time Restricted Feeding and Metabolic Rhythms |
| Actual Study Start Date : | January 15, 2019 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | June 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Early Time Restricted Feeding
Consume meals for 7 days during an 8 hour window starting 1 hour after habitual wake time.
|
Behavioral: Time Restricted Feeding
Consuming energy during a short interval during the day
|
|
Experimental: Mid-day Time Restricted Feeding
Consume meals for 7 days during an 8 hour window starting 6 hours after habitual wake time.
|
Behavioral: Time Restricted Feeding
Consuming energy during a short interval during the day
|
| Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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)
| United States, Colorado | |
| University of Colorado Anschutz Medical Campus | |
| Aurora, Colorado, United States, 80045 | |
| Principal Investigator: | Corey A Rynders, PhD | University of Colorado - Anschutz Medical Campus |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 27, 2019 | ||||
| First Posted Date ICMJE | July 5, 2019 | ||||
| Last Update Posted Date | August 10, 2020 | ||||
| Actual Study Start Date ICMJE | January 15, 2019 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Time Restricted Feeding and Metabolic Rhythms | ||||
| Official Title ICMJE | Time Restricted Feeding and Metabolic Rhythms | ||||
| Brief 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. 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 Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Behavioral: Time Restricted Feeding
Consuming energy during a short interval during the day
|
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| Study Arms ICMJE |
|
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| 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:CD013496. doi: 10.1002/14651858.CD013496.pub2. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE |
12 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | June 2021 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 20 Years to 50 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04009239 | ||||
| Other Study ID Numbers ICMJE | 16-2754 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Colorado, Denver | ||||
| Study Sponsor ICMJE | University of Colorado, Denver | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University of Colorado, Denver | ||||
| Verification Date | August 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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