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

NCT03210805 | Unknown

• 1 other identifier: R16-P138
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Epigenetic regulation of Cytokine Genes

  Blood Sample

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

Secondary Outcomes (17)

• Total Cholesterol

  Baseline, 7, 14, 21 and 28 days

• LDL (Low density lipoprotein)

  Baseline, 7, 14, 21 and 28 days

• HDL (High density lipoprotein)

  Baseline, 7, 14, 21 and 28 days

• Triglycerides

  Baseline, 7, 14, 21 and 28 days

• Fasting Glucose

  Baseline, 7, 14, 21 and 28 days

Study Arms (1)

Supplementation

EXPERIMENTAL

Omega-3 Polyunsaturated Fatty Acids

Dietary Supplement: Omega-3 Polyunsaturated Fatty Acids Supplementation

Interventions

Omega-3 Polyunsaturated Fatty Acids Supplementation DIETARY_SUPPLEMENT

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

Also known as: OmegaVia Pharmaceutical Grade Omega-3

Supplementation

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males
• Aged between 18 and 30 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bethan Hussey: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postgraduate PhD Research Student

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 7, 2017
• Study Start: January 9, 2017
• Primary Completion: August 1, 2017
• Study Completion: January 1, 2018
• Last Updated: July 7, 2017

Record last verified: 2017-07