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Exercise, Sleep Quality and Nocturnal Fat Oxidation in Metabolic Syndrome (ExerciZzz)

Primary Purpose

Metabolic Syndrome, PreDiabetes, Hypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Evening Exercise

Control

Arm Description

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 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

Outcomes

Primary Outcome Measures

Nocturnal FFA Concentrations
Free Fatty Acids (FFA) concentrations

Secondary Outcome Measures

Nocturnal Fat Oxidation
Total fat oxidation (measured by whole room calorimeter)
Nocturnal Glucose and Insulin Concentrations
Nocturnal glycemic control
Sleep Quality (Percent Time in Slow Wave Sleep [SWS])
Time spent in slow wave sleep
Sleep Latency
Time spent to fall asleep
Sleep Interruptions
Wake after sleep onset [WASO]

Full Information

First Posted
September 3, 2019
Last Updated
July 13, 2021
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04105218
Brief Title
Exercise, Sleep Quality and Nocturnal Fat Oxidation in Metabolic Syndrome
Acronym
ExerciZzz
Official Title
The Effect of Exercise on Sleep Quality and Nocturnal Fat Oxidation in Individuals With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Personnel resources required to conduct study are no longer available. Study was terminated due to lack of resources
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
March 2, 2021 (Actual)
Study Completion Date
March 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, PreDiabetes, Hypertension, Obesity, Hyperlipidemias

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evening Exercise
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nocturnal FFA Concentrations
Description
Free Fatty Acids (FFA) concentrations
Time Frame
8-hours
Secondary Outcome Measure Information:
Title
Nocturnal Fat Oxidation
Description
Total fat oxidation (measured by whole room calorimeter)
Time Frame
8-hours
Title
Nocturnal Glucose and Insulin Concentrations
Description
Nocturnal glycemic control
Time Frame
8-hours
Title
Sleep Quality (Percent Time in Slow Wave Sleep [SWS])
Description
Time spent in slow wave sleep
Time Frame
8-hours
Title
Sleep Latency
Description
Time spent to fall asleep
Time Frame
8-hours
Title
Sleep Interruptions
Description
Wake after sleep onset [WASO]
Time Frame
8-hours
Other Pre-specified Outcome Measures:
Title
Dietary Fat Oxidation
Description
Measured using a palmitate stable isotope tracer at breakfast
Time Frame
24-hours
Title
Distal/Proximal Temperature Gradient
Description
Skin temperature at distal and proximal body locations
Time Frame
24-hours
Title
Melatonin Offset
Description
Melatonin concentrations
Time Frame
First 5 hours of waking (after study condition)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Blankenship, PhD
Organizational Affiliation
jennifer.blankenship@cuanschutz.edu
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We currently do not have a plan to share IDP

Learn more about this trial

Exercise, Sleep Quality and Nocturnal Fat Oxidation in Metabolic Syndrome

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