Clinical trial NCT03210805: Investigating the Effect of 4-week Omega-3 Polyunsaturated Fatty Acid Supplementation on Inflammation
Official title: Investigating the Effect of 4-week Omega-3 Polyunsaturated Fatty Acid Supplementation on Inflammation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Epigenetic regulation of Cytokine Genes
timeFrame: Change from Baseline at 7, 14, 21 and 28 days
Secondary outcomes:
measure: Total Cholesterol
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: LDL (Low density lipoprotein)
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: HDL (High density lipoprotein)
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: Triglycerides
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: Fasting Glucose
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: Full Blood Count
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: Height
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: Weight
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: Hip Circumference
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: Waist Circumference
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: Systolic and Diastolic Blood Pressure
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: Heart rate
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: Food Diary
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: Exercise Questionnaire
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: Ethnic background
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: Gene expression of Cytokine Genes
timeFrame: Baseline, 7, 14, 21 and 28 days
measure: ex vivo stimulation of Human Derived Blood Cells
timeFrame: Baseline and 28 days
Other outcomes:
Locations:
Study officials:
References: