NCT06069245

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. 1.cardiopulmonary responses to submax and maximal exercise
  2. 2.Energy expenditure and fat/carbohydrate oxidation during sub maximal exercise.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
Last Updated

October 5, 2023

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

September 25, 2023

Last Update Submit

September 29, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory fitness

    VO2max

    acutely (1 hr)

Secondary Outcomes (5)

  • Ventilation

    acutely (1hr)

  • Heart rate

    acutely (1 hr)

  • Blood pressure

    acutely (1hr)

  • Maximal Fat Oxidation rate

    acutely (1hr)

  • Peak blood lactate

    acutely (1hr)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Gelatin capsules

Dietary Supplement: Placebo

MitoQ

EXPERIMENTAL

Commercially available MitoQ (80mg)

Dietary Supplement: MitoQ

Interventions

MitoQDIETARY_SUPPLEMENT

80mg of MitoQ taken in one dose on one occasion.

MitoQ
PlaceboDIETARY_SUPPLEMENT

Gelatin capsules

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ball State University

Muncie, Indiana, 47306, United States

Location

MeSH Terms

Interventions

mitoquinone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Double blind randomized placebo controlled crossover design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 5, 2023

Study Start

September 14, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

October 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)