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Personnel resources required to conduct study are no longer available. Study was terminated due to lack of resources
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The purpose of the Exerci-Zzz Study is to learn more about how the time of day that exercise is performed influences sleep quality and fat metabolism overnight in adults with metabolic syndrome. In this study, exercise will be performed in the early evening and the investigators will measure participants' sleep quality and fat metabolism overnight in a metabolic room. The total study will take approximately 2-3 months to complete.
Enrolled participants will complete 2 study conditions (evening exercise and control) in a metabolic room. Each of these visits will last 30 hours and require that the participant stay in the metabolic room. During the evening exercise participants will be asked to perform exercise in the early evening. Finally, during the control condition participants will be asked spend the day in the metabolic room (no exercise performed during this condition). During each of these conditions, the investigators will measure participant sleep quality and fat metabolism overnight. In the morning, the investigators will perform a metabolic test to assess the responses of certain hormones. Findings from this study will identify how exercise influences novel contributors to metabolic syndrome (sleep quality and nocturnal metabolism) and shed light on some potential mechanisms to explain the variability in exercise responses.
Metabolic syndrome (MetS) is a major risk factor for many chronic diseases, including diabetes and cardiovascular disease. Sleep is recognized a risk factor for many of the conditions comprising MetS (e.g. high blood sugars, obesity). Interestingly, fat metabolism during your sleep is important for regulating several key components of health, like risk of obesity and glucose tolerance. While exercise is recognized as a health enhancing behavior to reduce the risk of many chronic diseases, the effect of exercise on sleep quality and nocturnal fat metabolism is largely unknown. This study plans to learn more about how the time of day that you perform exercise influences sleep quality and fat metabolism overnight in adults with metabolic syndrome. In this study, exercise will be performed in the early evening and the investigators will measure your sleep quality and fat metabolism overnight in our metabolic room. Findings from this study will identify how exercise influences novel contributors to metabolic syndrome (sleep quality and nocturnal metabolism) and shed light on some potential mechanisms to explain the variability in exercise responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evening Exercise | Experimental | Participants will arrive in the Clinical and Translation Research Center (CTRC) and enter the whole room calorimeter approximately 1 hour after arrival. During the evening exercise condition, participants will perform 45-minutes of moderate intensity continuous exercise on a treadmill 12 hours after habitual wake time in the evening. Participants will begin with a warm-up for 5 minutes at 2.0-2.5 mph. Heart rate will be monitored continuously with a heart rate monitor. Participants will maintain heart rate at 65% of age-predicted maximum heart rate. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva |
|
| Control | Placebo Comparator | Participants will arrive in the Clinical and Translation Research Center (CTRC) in the morning within 2 hours of their habitual wake time. Participants will enter the whole room calorimeter approximately 1 hour after arriving at the CTRC. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control for potential confounding effects of hormonal variations across the menstrual cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal FFA Concentrations | Free Fatty Acids (FFA) concentrations | 8-hours |
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal Fat Oxidation | Total fat oxidation (measured by whole room calorimeter) | 8-hours |
| Nocturnal Glucose and Insulin Concentrations | Nocturnal glycemic control |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Fat Oxidation | Measured using a palmitate stable isotope tracer at breakfast | 24-hours |
| Distal/Proximal Temperature Gradient | Skin temperature at distal and proximal body locations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Blankenship, PhD | jennifer.blankenship@cuanschutz.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
We currently do not have a plan to share IDP
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This study screened 91 individuals and enrolled 12 participants, however, due to the multiple COVID-19 clinical research shutdowns, only one of the participants was able to complete any of the inpatient study visits (though she withdrew after this visit). During the COVID19 shutdowns, 6 of the 12 participants withdrew from the study primarily due to increased childcare responsibilities. 3 participants failed screening tests during the baseline visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Evening Exercise Condition --> Control Condition | Participants will arrive in the Clinical and Translation Research Center (CTRC) and enter the whole room calorimeter approximately 1 hour after arrival. Participants will perform 45-min of moderate intensity continuous exercise on a treadmill 12 hours after habitual wake time in the evening. Participants will begin with a warm-up for 5 minutes at 2.0-2.5 mph. Heart rate will be monitored continuously with a heart rate monitor. Participants will maintain heart rate at 65% of age-predicted maximum heart rate. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control |
| FG001 | Control Condition --> Evening Exercise Condition | Participants will arrive in the Clinical and Translation Research Center (CTRC) in the morning within 2 hours of their habitual wake time. Participants will enter the whole room calorimeter approximately 1 hour after arriving at the CTRC. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control for potential confounding effects of hormonal variations across the menstrual cycle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Evening Exercise Condition --> Control Condition | Participants will arrive in the Clinical and Translation Research Center (CTRC) and enter the whole room calorimeter approximately 1 hour after arrival. Participants will perform 45-min of moderate intensity continuous exercise on a treadmill 12 hours after habitual wake time in the evening. Participants will begin with a warm-up for 5 minutes at 2.0-2.5 mph. Heart rate will be monitored continuously with a heart rate monitor. Participants will maintain heart rate at 65% of age-predicted maximum heart rate. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nocturnal FFA Concentrations | Free Fatty Acids (FFA) concentrations | Study terminated before sufficient outcome measure data could be collected to make analysis possible for this outcome measure. No data was able to be analyzed. | Posted | 8-hours |
|
Up to12 months
Adverse event definition is the same as clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Evening Exercise | Participants will arrive in the Clinical and Translation Research Center (CTRC) and enter the whole room calorimeter approximately 1 hour after arrival. Participants will perform 45-min of moderate intensity continuous exercise on a treadmill 12 hours after habitual wake time in the evening. Participants will begin with a warm-up for 5 minutes at 2.0-2.5 mph. Heart rate will be monitored continuously with a heart rate monitor. Participants will maintain heart rate at 65% of age-predicted maximum heart rate. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Support Center | University of Colorado Anschutz Medical Campus | 303-724-1111 | clinicalresearchsupportcenter@ucdenver.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2020 | Jul 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D011236 | Prediabetic State |
| D006973 | Hypertension |
| D009765 | Obesity |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| 8-hours |
| Sleep Quality (Percent Time in Slow Wave Sleep [SWS]) | Time spent in slow wave sleep | 8-hours |
| Sleep Latency | Time spent to fall asleep | 8-hours |
| Sleep Interruptions | Wake after sleep onset [WASO] | 8-hours |
| 24-hours |
| Melatonin Offset | Melatonin concentrations | First 5 hours of waking (after study condition) |
| Failed screening tests |
|
| BG001 | Control Condition --> Evening Exercise Condition | Participants will arrive in the Clinical and Translation Research Center (CTRC) in the morning within 2 hours of their habitual wake time. Participants will enter the whole room calorimeter approximately 1 hour after arriving at the CTRC. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control for potential confounding effects of hormonal variations across the menstrual cycle. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Participants will arrive in the Clinical and Translation Research Center (CTRC) in the morning within 2 hours of their habitual wake time. Participants will enter the whole room calorimeter approximately 1 hour after arriving at the CTRC. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control for potential confounding effects of hormonal variations across the menstrual cycle. |
|
| Secondary | Nocturnal Fat Oxidation | Total fat oxidation (measured by whole room calorimeter) | Study terminated before sufficient outcome measure data could be collected to make analysis possible for this outcome measure. No data was able to be analyzed. | Posted | 8-hours |
|
|
| Secondary | Nocturnal Glucose and Insulin Concentrations | Nocturnal glycemic control | Study terminated before sufficient outcome measure data could be collected to make analysis possible for this outcome measure. No data was able to be analyzed. | Posted | 8-hours |
|
|
| Secondary | Sleep Quality (Percent Time in Slow Wave Sleep [SWS]) | Time spent in slow wave sleep | Study terminated before sufficient outcome measure data could be collected to make analysis possible for this outcome measure. No data was able to be analyzed. | Posted | 8-hours |
|
|
| Secondary | Sleep Latency | Time spent to fall asleep | Study terminated before sufficient outcome measure data could be collected to make analysis possible for this outcome measure. No data was able to be analyzed. | Posted | 8-hours |
|
|
| Secondary | Sleep Interruptions | Wake after sleep onset [WASO] | Study terminated before sufficient outcome measure data could be collected to make analysis possible for this outcome measure. No data was able to be analyzed. | Posted | 8-hours |
|
|
| Other Pre-specified | Dietary Fat Oxidation | Measured using a palmitate stable isotope tracer at breakfast | Study terminated before sufficient outcome measure data could be collected to make analysis possible for this outcome measure. No data was able to be analyzed. | Posted | 24-hours |
|
|
| Other Pre-specified | Distal/Proximal Temperature Gradient | Skin temperature at distal and proximal body locations | Study terminated before sufficient outcome measure data could be collected to make analysis possible for this outcome measure. No data was able to be analyzed. | Posted | 24-hours |
|
|
| Other Pre-specified | Melatonin Offset | Melatonin concentrations | Study terminated before sufficient outcome measure data could be collected to make analysis possible for this outcome measure. No data was able to be analyzed. | Posted | First 5 hours of waking (after study condition) |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Control | Participants will arrive in the Clinical and Translation Research Center (CTRC) in the morning within 2 hours of their habitual wake time. Participants will enter the whole room calorimeter approximately 1 hour after arriving at the CTRC. Throughout the day, participants will be required to eat the standardized meals provided at breakfast lunch and dinner. At the time of bed, participants will be instructed to turn off the lights, lay down in bed and to refrain from using electronic devices. In the morning, a metabolic test will be performed and melatonin levels will be measured in the saliva Exercise: Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control for potential confounding effects of hormonal variations across the menstrual cycle. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |