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

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Omega-3 Polyunsaturated Fatty Acids Supplementation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |