Effect of Combined Fatty Acid Supplementation and Eccentr... | NCT03259412

Studies
Effect of Combined Fatty Acid Supplementation and Eccentric Exercise Training on Exercise Performance

NCT03259412

Sponsor

Loughborough University

Status

Completed

Last Update Posted

Mar 27, 2018Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Exercise-induced Inflammation

Interventions

Fish Oil
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Dec 20, 2017Actual

Completion Date

Dec 20, 2017Actual

First Submitted Date

Aug 4, 2017

First Submission Date that Met QC Criteria

Aug 22, 2017

First Posted Date

Aug 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2018

Last Update Posted Date

Mar 27, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lynsey Wilson, Technical Tutor in Exercise Physiology/ PhD Student, Loughborough UniversityPrincipal Investigator

Lead Sponsor

Loughborough UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to determine whether fish oil (specifically omega-3 long chain polyunsaturated fatty acids [EPA-DHA]) supplementation can enhance eccentric resistance exercise performance when combined with a resistance exercise training study. The investigators aim to establish the potential mechanisms that might mediate performance changes at a cellular level.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fish Oil	Experimental	Fish oil 5.1g/ day - Premium Omega-3, Norwegian Pure-3, Oslo, Norway	Dietary Supplement: Fish Oil
Placebo	Placebo Comparator	Olive Oil 6g/ day - Premium Omega-3, Norwegian Pure-3, Oslo, Norway	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fish Oil	Dietary Supplement	Fish Oil Capsule	Fish Oil	n-3 PUFA, Omega-3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Strength	Quadriceps and Hamstring strength using an isokinetic dynamometer	Change from baseline strength at 11 weeks
Leg power	Dynamic leg power assessed through jump height on force platform	Change from baseline strength at 11 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males
Healthy

Exclusion Criteria:

Resistance exercise training within the past 6 months
Vitamin or fish oil supplementation over the past 6 months
Habitual use of anti-inflammatory drugs
History of heart disease
History of coagulation/bleeding disorder
History of metabolic disease
Serious allergy
Known to have blood-borne virus
Females (Due to differences in cell membrane incorporation of Omega-3 between the sexes and the testing schedule being unable to fit in with menstrual cycle, altering the blood markers that are being measured)
Currently no symptoms of general illness

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lynsey S Wilson, MSc	Loughborough University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Loughborough University		Leicester		LE11 3TU	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005395	Fish Oils
D015525	Fatty Acids, Omega-3
D004281	Docosahexaenoic Acids
D000069463	Olive Oil

Ancestor Terms

ID	Term
D009821	Oils
D008055	Lipids
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats

Browse Leaves

Not provided

Browse Branches

Not provided