Clinical trial NCT06069245: MitoQ & Cardiopulmonary Responses During Exercise
Official title: The Acute Effects of Mitochondrial Antioxidant Supplementation on Metabolic Flexibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Ball State University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double blind randomized placebo controlled crossover design
Primary purpose: BASIC_SCIENCE

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 fat/carbohydrate 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 intervention(s) 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 intervention(s)

* 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 8:00pm 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.

Eligibility criteria: Inclusion Criteria:

* Be greater than or equal to 18 years of age
* Have a resting seated systolic blood pressure (SBP) of less than 160 mmHg and diastolic blood pressure (DBP) less than 100 mmHg
* Nonsmoker
* Body mass index (BMI) less than or equal to 35 kg/m2
* Considered physically inactive defined as participating in \<150 min/week of moderate physical activity or \<75 minutes/week of vigorous activity (ACSM).

Exclusion Criteria:

* participants that cannot complete the exercise protocol or have any signs/symptoms suggestive of cardiovascular or metabolic disease.
* Individuals that are currently on beta blockers
* diagnosed with type II diabetes will be excluded.

Primary outcomes:
measure: Cardiorespiratory fitness
timeFrame: acutely (1 hr)
Secondary outcomes:
measure: Ventilation
timeFrame: acutely (1hr)
measure: Heart rate
timeFrame: acutely (1 hr)
measure: Blood pressure
timeFrame: acutely (1hr)
measure: Maximal Fat Oxidation rate
timeFrame: acutely (1hr)
measure: Peak blood lactate
timeFrame: acutely (1hr)
Other outcomes:
Locations:
city: Muncie
country: United States
facility: Ball State University
state: Indiana
Study officials:
References: