- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04105218
Exercise, Sleep Quality and Nocturnal Fat Oxidation in Metabolic Syndrome (ExerciZzz)
The Effect of Exercise on Sleep Quality and Nocturnal Fat Oxidation in Individuals With Metabolic Syndrome
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Anschutz Medical Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- not currently meeting physical activity guidelines (<150 minutes moderate to vigorous physical activity per week);
- weight stable (<5% change in weight over the last 6 months);
- habitual sleep duration of 7-8 hours and consistent sleep/wake schedule (<1 hour variation night-to-night).
Exclusion Criteria:
- body mass index >35.0 kg/m2; pregnancy;
- post-menopausal status in women, confirmed by absences of menses for >1 year and elevated follicular stimulating hormone concentrations (>50 mIU/mL); women on oral contraceptives;
- self-reported diabetes, cardiovascular disease, or sleep disorder;
- untreated hyper/hypothyroidism, cancer;
- inability to perform moderate to vigorous treadmill exercise;
- shiftwork
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Evening Exercise
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
|
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.
|
PLACEBO_COMPARATOR: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nocturnal FFA Concentrations
Time Frame: 8-hours
|
Free Fatty Acids (FFA) concentrations
|
8-hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nocturnal Fat Oxidation
Time Frame: 8-hours
|
Total fat oxidation (measured by whole room calorimeter)
|
8-hours
|
Nocturnal Glucose and Insulin Concentrations
Time Frame: 8-hours
|
Nocturnal glycemic control
|
8-hours
|
Sleep Quality (Percent Time in Slow Wave Sleep [SWS])
Time Frame: 8-hours
|
Time spent in slow wave sleep
|
8-hours
|
Sleep Latency
Time Frame: 8-hours
|
Time spent to fall asleep
|
8-hours
|
Sleep Interruptions
Time Frame: 8-hours
|
Wake after sleep onset [WASO]
|
8-hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary Fat Oxidation
Time Frame: 24-hours
|
Measured using a palmitate stable isotope tracer at breakfast
|
24-hours
|
Distal/Proximal Temperature Gradient
Time Frame: 24-hours
|
Skin temperature at distal and proximal body locations
|
24-hours
|
Melatonin Offset
Time Frame: First 5 hours of waking (after study condition)
|
Melatonin concentrations
|
First 5 hours of waking (after study condition)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Blankenship, PhD, jennifer.blankenship@cuanschutz.edu
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0369
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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