Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06069245
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2023-09-25
Brief Title:
MitoQ Cardiopulmonary Responses During Exercise
Sponsor:
Ball State University
Organization:
Ball State University
Study Overview
Official Title:
The Acute Effects of Mitochondrial Antioxidant Supplementation on Metabolic Flexibility
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study Purpose To examine the acute effects of antioxidant supplementation on energy use during a single bout of exercise in apparently healthy adult men and women
Specifically this study examined the acute effect of MitoQ on
1 cardiopulmonary responses to submax and maximal exercise
2 Energy expenditure and fatcarbohydrate oxidation during sub maximal exercise
In a double-blind randomized placebo controlled cross-over study design participants performed 2 experimental trials which differed only in the supplement consumed MitoQ or Placebo Participants performed identical exercise protocols which consisted of a series of submaximal workloads followed by a ramp protocol to volitional exhaustion
Specifically this study examined the acute effect of MitoQ on
1 cardiopulmonary responses to submax and maximal exercise
2 Energy expenditure and fatcarbohydrate oxidation during sub maximal exercise
In a double-blind randomized placebo controlled cross-over study design participants performed 2 experimental trials which differed only in the supplement consumed MitoQ or Placebo Participants performed identical exercise protocols which consisted of a series of submaximal workloads followed by a ramp protocol to volitional exhaustion
Detailed Description:
Participants performed the following 3 study visits
Visit 1 consisted of baseline resting measures including blood pressure and blood vessel health blood biomarkers and body composition assessments
Visits 2 and 3 were the acute supplementation interventions with either MitoQ or Placebo in a randomly designed order These visits included an assessment of blood pressure and blood vessel health and an exercise test on a stationary cycle There was a minimum of 48-72 hours between trials 2 and 3
Visit 1
Participants arrived at the laboratory fasted from all food and drink other than water for at least 12 hours The following assessments were performed
Informed consent and health history questionnaire
Resting heart rate handgrip strength and body composition
Resting electrocardiogram ECG
Blood biomarkers Total cholesterol HDL LDL-C and triglycerides as well as fasting blood glucose and HbA1c
Blood pressure
Visit 2 3 performed in a randomized order differing only in the supplement consumed
Acute supplementation interventions
The night before both the Placebo and MitoQ trials participants were asked to eat the same meal at the same time of night and were provided with a standard Ensure shake to consume at 800pm the night before each trial
Upon arrival they rested supine for 10 minutes before consuming supplement MitoQ or Placebo
Following consumption of the supplement or placebo participants completed a graded aerobic exercise protocol This test involved riding on a stationary cycle to exhaustion The total test duration was 30-45 minutes which included a break to rest between the submax and maximal portions Heart function was monitored with an electrocardiogram ECG A gas analysis cart was used to determine the composition of the air breathed in and out during the test for the determination of substrate oxidation rates and VO2max Heart rate was measured continuously throughout the exercise protocol from the ECG Rate of perceived exertion RPE was measured every minute and blood pressure BP was performed every third minute of the exercise protocol Additional measures of blood lactate via a finger stick were performed during the exercise protocol
Visit 1 consisted of baseline resting measures including blood pressure and blood vessel health blood biomarkers and body composition assessments
Visits 2 and 3 were the acute supplementation interventions with either MitoQ or Placebo in a randomly designed order These visits included an assessment of blood pressure and blood vessel health and an exercise test on a stationary cycle There was a minimum of 48-72 hours between trials 2 and 3
Visit 1
Participants arrived at the laboratory fasted from all food and drink other than water for at least 12 hours The following assessments were performed
Informed consent and health history questionnaire
Resting heart rate handgrip strength and body composition
Resting electrocardiogram ECG
Blood biomarkers Total cholesterol HDL LDL-C and triglycerides as well as fasting blood glucose and HbA1c
Blood pressure
Visit 2 3 performed in a randomized order differing only in the supplement consumed
Acute supplementation interventions
The night before both the Placebo and MitoQ trials participants were asked to eat the same meal at the same time of night and were provided with a standard Ensure shake to consume at 800pm the night before each trial
Upon arrival they rested supine for 10 minutes before consuming supplement MitoQ or Placebo
Following consumption of the supplement or placebo participants completed a graded aerobic exercise protocol This test involved riding on a stationary cycle to exhaustion The total test duration was 30-45 minutes which included a break to rest between the submax and maximal portions Heart function was monitored with an electrocardiogram ECG A gas analysis cart was used to determine the composition of the air breathed in and out during the test for the determination of substrate oxidation rates and VO2max Heart rate was measured continuously throughout the exercise protocol from the ECG Rate of perceived exertion RPE was measured every minute and blood pressure BP was performed every third minute of the exercise protocol Additional measures of blood lactate via a finger stick were performed during the exercise protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None