Exercise, Sleep Quality and Nocturnal Fat Oxidation in Metabolic Syndrome

Obesity Clinical Trial

— ExerciZzz  

Official title:

The Effect of Exercise on Sleep Quality and Nocturnal Fat Oxidation in Individuals With Metabolic Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04105218
• Other study ID #: 18-0369
• Status: Terminated
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: March 2, 2021

Study information

• Verified date: July 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2, 2021
• Est. primary completion date: March 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias
• Hypertension
• Metabolic Syndrome
• Obesity
• PreDiabetes
• Syndrome

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary Fat Oxidation	Measured using a palmitate stable isotope tracer at breakfast	24-hours
Other	Distal/Proximal Temperature Gradient	Skin temperature at distal and proximal body locations	24-hours
Other	Melatonin Offset	Melatonin concentrations	First 5 hours of waking (after study condition)
Primary	Nocturnal FFA Concentrations	Free Fatty Acids (FFA) concentrations	8-hours
Secondary	Nocturnal Fat Oxidation	Total fat oxidation (measured by whole room calorimeter)	8-hours
Secondary	Nocturnal Glucose and Insulin Concentrations	Nocturnal glycemic control	8-hours
Secondary	Sleep Quality (Percent Time in Slow Wave Sleep [SWS])	Time spent in slow wave sleep	8-hours
Secondary	Sleep Latency	Time spent to fall asleep	8-hours
Secondary	Sleep Interruptions	Wake after sleep onset [WASO]	8-hours