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

Healthy Clinical Trial

— STC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03210805
• Other study ID #: R16-P138
• Status: Active, not recruiting
• Phase: N/A
• First received: July 4, 2017
• Last updated: July 5, 2017
• Start date: January 9, 2017
• Est. completion date: January 2018

Study information

• Verified date: July 2017
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: January 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Inflammation

Intervention

Dietary Supplement:
• Omega-3 Polyunsaturated Fatty Acids Supplementation
28 days of a commercially available supplement. 4 capsules per day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bethan Hussey

Outcome

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