Trial Outcomes & Findings for Examining Endogenous Antioxidant Levels in Well Trained Cyclists (NCT NCT02281851)

Results Overview

To examine the effects of habitual vitamin and antioxidant supplementation on endogenous antioxidant production, participants will have a muscle biopsy taken at rest to examine any differences in endogenous antioxidant protein concentrations

Recruitment status

COMPLETED

Target enrollment

14 participants

Primary outcome timeframe

Protein concentrations will be measured at baseline only

Results posted on

2020-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Supplemented The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months	Non-supplemented The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements
Overall Study STARTED	4	10
Overall Study COMPLETED	4	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Examining Endogenous Antioxidant Levels in Well Trained Cyclists

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supplemented n=4 Participants The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months	Non-Supplemented n=10 Participants The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United Kingdom	4 participants n=5 Participants	10 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Protein concentrations will be measured at baseline only

To examine the effects of habitual vitamin and antioxidant supplementation on endogenous antioxidant production, participants will have a muscle biopsy taken at rest to examine any differences in endogenous antioxidant protein concentrations

Outcome measures

Outcome measures
Measure	Supplemented n=4 Participants The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months	Non-Supplemented n=10 Participants The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements
Difference in Resting Levels of Endogenous Antioxidant Proteins in Skeletal Muscle - Superoxide Dismutase 2 (SOD-2)	0.42 Arbitrary Units Standard Deviation 0.2	0.68 Arbitrary Units Standard Deviation 0.32

Adverse Events

Supplemented

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Supplemented

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mathew Soden

University of Birmingham

Phone: 07800549318

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place