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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Omega-3 Polyunsaturated Fatty Acids Supplementation

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supplementation; Omega-3 Polyunsaturated Fatty Acids	Dietary supplement: Omega-3 Polyunsaturated Fatty Acids Supplementation; 28 days of a commercially available supplement. 4 capsules per day.; Other Names: OmegaVia Pharmaceutical Grade Omega-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epigenetic regulation of Cytokine Genes	Blood Sample	Change from Baseline at 7, 14, 21 and 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Cholesterol	Biochemical variable	Baseline, 7, 14, 21 and 28 days
LDL (Low density lipoprotein)	Biochemical variable	Baseline, 7, 14, 21 and 28 days
HDL (High density lipoprotein)	Biochemical variable	Baseline, 7, 14, 21 and 28 days
Triglycerides	Biochemical variable	Baseline, 7, 14, 21 and 28 days
Fasting Glucose	Biochemical variable	Baseline, 7, 14, 21 and 28 days
Full Blood Count	Biochemical variable	Baseline, 7, 14, 21 and 28 days
Height	Standard Anthropometric Variables	Baseline, 7, 14, 21 and 28 days
Weight	Standard Anthropometric Variables	Baseline, 7, 14, 21 and 28 days
Hip Circumference	Standard Anthropometric Variables	Baseline, 7, 14, 21 and 28 days
Waist Circumference	Standard Anthropometric Variables	Baseline, 7, 14, 21 and 28 days
Systolic and Diastolic Blood Pressure	Standard Anthropometric Variables	Baseline, 7, 14, 21 and 28 days
Heart rate	Standard Anthropometric Variables	Baseline, 7, 14, 21 and 28 days
Food Diary	Self-reporting	Baseline, 7, 14, 21 and 28 days
Exercise Questionnaire	Questionnaire	Baseline, 7, 14, 21 and 28 days
Ethnic background	Questionnaire	Baseline, 7, 14, 21 and 28 days
Gene expression of Cytokine Genes	Extracted PBMCs	Baseline, 7, 14, 21 and 28 days
ex vivo stimulation of Human Derived Blood Cells	Extracted PBMCs	Baseline and 28 days

Collaborators and Investigators

• Sponsor: Bethan Hussey

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2017
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: R16-P138

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No