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

Primary Purpose

Healthy

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Omega-3 Polyunsaturated Fatty Acids Supplementation

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supplementation

Arm Description

Omega-3 Polyunsaturated Fatty Acids

Outcomes

Primary Outcome Measures

Epigenetic regulation of Cytokine Genes

Blood Sample

Secondary Outcome Measures

Total Cholesterol

Biochemical variable

LDL (Low density lipoprotein)

Biochemical variable

HDL (High density lipoprotein)

Biochemical variable

Triglycerides

Biochemical variable

Fasting Glucose

Biochemical variable

Full Blood Count

Biochemical variable

Height

Standard Anthropometric Variables

Weight

Standard Anthropometric Variables

Hip Circumference

Standard Anthropometric Variables

Waist Circumference

Standard Anthropometric Variables

Systolic and Diastolic Blood Pressure

Standard Anthropometric Variables

Heart rate

Standard Anthropometric Variables

Food Diary

Self-reporting

Exercise Questionnaire

Questionnaire

Ethnic background

Questionnaire

Gene expression of Cytokine Genes

Extracted PBMCs

ex vivo stimulation of Human Derived Blood Cells

Extracted PBMCs

Full Information

NCT ID

NCT03210805

First Posted

July 4, 2017

Last Updated

July 5, 2017

Sponsor

Bethan Hussey

1. Study Identification

Unique Protocol Identification Number

NCT03210805

Brief Title

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

Acronym

STC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 9, 2017 (Actual)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Bethan Hussey

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supplementation

Arm Type

Experimental

Arm Description

Omega-3 Polyunsaturated Fatty Acids

Intervention Type

Dietary Supplement

Intervention Name(s)

Omega-3 Polyunsaturated Fatty Acids Supplementation

Other Intervention Name(s)

OmegaVia Pharmaceutical Grade Omega-3

Intervention Description

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

Primary Outcome Measure Information:

Title

Epigenetic regulation of Cytokine Genes

Description

Blood Sample

Time Frame

Change from Baseline at 7, 14, 21 and 28 days

Secondary Outcome Measure Information:

Title

Total Cholesterol

Description

Biochemical variable

Time Frame