Investigating the Effect of 4-week Omega-3 Polyunsaturated Fatty Acid Supplementation on Inflammation

NCT ID: NCT03210805

Last Updated: 2017-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2018-01-31

Brief Summary

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Investigate the in vivo effects of n-3 PUFA supplementation on inflammation, gene expression and epigenetic signatures.

Ex vivo stimulation of peripheral blood mononuclear cells (PBMCs) collected pre and post n-3 supplementation and measurement of it's effect on inflammation, gene expression and epigenetic signatures.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Supplementation

Omega-3 Polyunsaturated Fatty Acids

Group Type EXPERIMENTAL

Omega-3 Polyunsaturated Fatty Acids Supplementation

Intervention Type DIETARY_SUPPLEMENT

28 days of a commercially available supplement. 4 capsules per day.

Interventions

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Omega-3 Polyunsaturated Fatty Acids Supplementation

28 days of a commercially available supplement. 4 capsules per day.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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OmegaVia Pharmaceutical Grade Omega-3

Eligibility Criteria

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Inclusion Criteria

* Healthy males
* Aged between 18 and 30 years

Exclusion Criteria

* Females (Due to differences in cell membrane incorporation of n-3 PUFAs between the sexes and the testing schedule being unable to fit in with menstrual cycle, therefore altering the blood markers that are being measured).
* Aged below 18 or above 30.
* Body mass index (BMI; in kg/ m2), below 18 or above 30.
* Use of vitamin or fish oil supplements in the last 6 months.
* High habitual oily fish consumption (\<4 servings per month).
* Smoking.
* Changes in weight in the past 6 months (Dieting) or planning on changing dietary habits.
* Habitual use of anti-inflammatory drugs.
* Self-reported history of diabetes.
* History of heart disease, coagulation/bleeding disorders, metabolic disease or Serious allergy.
* Known to have blood-borne virus.
* Receipt of inoculations within 2 months of starting the study or the intention to receive such during the study.
* Donation of or intention to donate blood within 8 weeks of the first sample or at any point during the intervention.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bethan Hussey

OTHER

Sponsor Role lead

Responsible Party

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Bethan Hussey

Postgraduate PhD Research Student

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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R16-P138

Identifier Type: -

Identifier Source: org_study_id

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