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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06069245
Other study ID # 1946841-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2022
Est. completion date April 30, 2023

Study information

Verified date September 2023
Source Ball State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
MitoQ
80mg of MitoQ taken in one dose on one occasion.
Placebo
Gelatin capsules

Locations

Country Name City State
United States Ball State University Muncie Indiana

Sponsors (1)

Lead Sponsor Collaborator
Ball State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiorespiratory fitness VO2max acutely (1 hr)
Secondary Ventilation L/min acutely (1hr)
Secondary Heart rate beats per minute acutely (1 hr)
Secondary Blood pressure mmHg acutely (1hr)
Secondary Maximal Fat Oxidation rate g/min acutely (1hr)
Secondary Peak blood lactate mmol acutely (1hr)
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