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

Not Applicable

• Conditions: Healthy
• Interventions: Dietary Supplement: Omega-3 Polyunsaturated Fatty Acids Supplementation

• Registration Number: NCT03210805
• Lead Sponsor: Bethan Hussey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-09
• Status Verified: 2017-07
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-05
• Last Update Submitted: 2017-07-05
• Study First Posted: 2017-07-07
• Last Update Posted: 2017-07-07
• Primary Completion: 2017-08
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supplementation	Omega-3 Polyunsaturated Fatty Acids Supplementation	Omega-3 Polyunsaturated Fatty Acids

Primary Outcome Measures

Name	Time	Method
Epigenetic regulation of Cytokine Genes	Change from Baseline at 7, 14, 21 and 28 days	Blood Sample

Secondary Outcome Measures

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