HealthyNCT06069245
MitoQ & Cardiopulmonary Responses During Exercise
A study testing MitoQ in people with Healthy, run by Ball State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MitoQ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effects of Mitochondrial Antioxidant Supplementation on Metabolic Flexibility
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:
Read more
- cardiopulmonary responses to submax and maximal exercise
- 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- MitoQ, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoQDietary supplement
80mg of MitoQ taken in one dose on one occasion.
PlaceboDietary supplement
Gelatin capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Gelatin capsules Receives: Dietary Supplement: Placebo |
| MitoQ | Experimental | Commercially available MitoQ (80mg) Receives: Dietary Supplement: MitoQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
VO2max
Measured: acutely (1 hr)
Secondary outcomes (5)
Ventilation
L/min
Measured: acutely (1hr)
Heart rate
beats per minute
Measured: acutely (1 hr)
Blood pressure
mmHg
Measured: acutely (1hr)
Maximal Fat Oxidation rate
g/min
Measured: acutely (1hr)
Peak blood lactate
mmol
Measured: acutely (1hr)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start14 Sep 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double blind randomized placebo controlled crossover design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ball State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069245
- Sponsor's protocol ID
- 1946841-3
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Mitochondrial Antioxidant Supplementation on Metabolic Flexibility
- ClinicalTrials.gov ID
- NCT06069245
- Acronym / sponsor ID
- 1946841-3
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ball State UniversityUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- cardiopulmonary responses to submax and maximal exercise
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind randomized placebo controlled crossover design
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboGelatin capsules |
| MitoQ | Experimental | Dietary Supplement: MitoQCommercially available MitoQ (80mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitoQ80mg of MitoQ taken in one dose on one occasion. | Dietary supplement | MitoQ |
| PlaceboGelatin capsules | Dietary supplement | Placebo |
Primary outcome
Cardiorespiratory fitness
Time frame: acutely (1 hr)
VO2max
5 secondary outcomes
Ventilation
Time frame: acutely (1hr)
Heart rate
Time frame: acutely (1 hr)
Blood pressure
Time frame: acutely (1hr)
Maximal Fat Oxidation rate
Time frame: acutely (1hr)
Peak blood lactate
Time frame: acutely (1hr)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MitoQ in people with Healthy, run by Ball State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (time frame: acutely (1 hr)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.