Examining Endogenous Antioxidant Levels in Well Trained Cyclists

• Sponsor: University of Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT02281851
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Actual Duration (Months): 34
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study will investigate whether increased habitual intake of antioxidant supplements effects the concentration of endogenous antioxidants, the response of antioxidants to exercise, and differences in oxidative damage compared to a non-supplemented group.

Condition or Disease	Intervention/Treatment	Phase
Oxidative Stress

Study Design

• Study Type: Observational
• Actual Enrollment: 14 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Official Title: The Effects of Habitual Antioxidant Supplementation on Endogenous Antioxidants and Oxidative Damage in Well Trained Cyclists
• Actual Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Difference in Resting Levels of Endogenous Antioxidant Proteins in Skeletal Muscle - Superoxide Dismutase 2 (SOD-2) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male,

• BMI 18.8 29.9 kg/m2

• cycle 3-7 times a week for durations longer than 60 minutes

• cycled for a minimum of 3 years

• accustomed to exhaustive cycling protocols

• healthy (no known cardiovascular or metabolic disease)

Exclusion Criteria:

• answering "NO" to any question on the general health questionnaire would result in exclusion from the study

• current participation in another clinical study

• current or recent smoker (last 30 days)

• prescription or non-prescription of anti-inflammatory use >30 days prior to the experiment commencing or any other medications that in the opinion of the investigator may interfere with redox signalling

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Sport Exercise and Rehabilitation Sciences, University of Birmingham	Birmingham	West Midlands	United Kingdom	B15 2TT

Sponsors and Collaborators

• University of Birmingham

Investigators

• Principal Investigator: Sarah Aldred, MSc PhD, University of Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Birmingham
• ClinicalTrials.gov Identifier: NCT02281851
• Other Study ID Numbers: 125663; 13/WM/0226
• First Posted: Nov 4, 2014
• Last Update Posted: Aug 11, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by University of Birmingham: Endogenous antioxidants; Antioxidant supplements; Vitamin Supplements; Exercise adaptations; Oxidative stress; Redox regulation; Cycling - exercise

Study Results

Participant Flow

Arm/Group Title	Supplemented	Non-supplemented
Arm/Group Description	The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months	The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements
Period Title: Overall Study
STARTED	4	10
COMPLETED	4	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Supplemented	Non-Supplemented	Total
Arm/Group Description	The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months	The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements	Total of all reporting groups
Overall Participants	4	10	14
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 100%	10 100%	14 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	4 100%	10 100%	14 100%
Region of Enrollment (participants) [Number]
United Kingdom	4 100%	10 100%	14 100%

Outcome Measures

1. Primary Outcome

Title	Difference in Resting Levels of Endogenous Antioxidant Proteins in Skeletal Muscle - Superoxide Dismutase 2 (SOD-2)
Description	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
Time Frame	Protein concentrations will be measured at baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supplemented	Non-Supplemented
Arm/Group Description	The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months	The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements
Measure Participants	4	10
Mean (Standard Deviation) [Arbitrary Units]	0.42 (0.2)	0.68 (0.32)

Adverse Events

Arm/Group Title	Supplemented		Non-Supplemented
Arm/Group Description	The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months		The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements
All Cause Mortality
	Supplemented		Non-Supplemented
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Supplemented		Non-Supplemented
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Supplemented		Non-Supplemented
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/10 (0%)

Limitations/Caveats

We underestimated the pool of cyclists who consumed antioxidants (>6 months) and would be willing to undertake a muscle core biopsy. In addition, the vitamin supplements consumed by the participants varied in concentration, compound and variety.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.