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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03205241
Other study ID # R14-P72
Secondary ID
Status Completed
Phase N/A
First received June 28, 2017
Last updated June 29, 2017
Start date April 2014
Est. completion date December 2014

Study information

Verified date June 2017
Source Loughborough University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Research Plan

Eleven trained cyclists have completed 4 cycling performance trials, before and after 4 weeks of fish oil supplementation and before and after 4 weeks of placebo with a 4 week washout between supplementation periods. During the performance trials blood, expired air and heart rate were collected. The blood samples have been used to investigate the production of inflammation resulting from the cycling performance test. Inflammation has been assessed using enzyme-linked immunosorbent assay for IL-6, which is an inflammatory cytokine. Work done from the cycling performance will be analysed to investigate whether there is a relationship with power and inflammation and whether this is modulated by fish oil supplementation.

Specific Aims

1. Does 4 weeks of Fish Oil supplementation attenuate the inflammatory response following high intensity cycling.

2. Is a modulation of the inflammatory response connected to cycling performance.

Hypotheses

1. Four weeks of n3-PUFA supplementation will reduce the inflammatory response

2. A reduction in inflammation will improve cycling performance

Anticipated Outcomes

A high level of cycling performance, indicated by a high average power, will be associated with high levels of systemic inflammation. n3-PUFA supplementation will decrease the level of inflammation and consequently cycling performance will be improved.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- recreationally trained male cyclists

Exclusion Criteria:

- History of coagulation/bleeding disorder

- History of metabolic disease

- Serious allergy

- History of heart disease

- Regular use of anti-inflammatory drugs

- Vitamin or fish oil supplementation over the past 6 months

- Known to have blood-borne virus

- Females

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
n-3 PUFA
n-3 PUFA capsules containing EPA and DHA
Placebo
Olive oil capsules

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Loughborough University University of Worcester

Outcome

Type Measure Description Time frame Safety issue
Primary Work Done Work done measured in Joules from the Lode cycle ergometer during 15 minute cycling time trial 15 minutes during time trial
See also
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Completed NCT01775384 - Polyphenols, Exercise, and Metabolomics N/A