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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03210805
Acronym
STC
Enrollment
17
Registered
2017-07-07
Start date
2017-01-09
Completion date
2018-01-31
Last updated
2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DIETARY_SUPPLEMENTOmega-3 Polyunsaturated Fatty Acids Supplementation

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

Sponsors

Bethan Hussey
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Epigenetic regulation of Cytokine GenesChange from Baseline at 7, 14, 21 and 28 daysBlood Sample

Secondary

MeasureTime frameDescription
Total CholesterolBaseline, 7, 14, 21 and 28 daysBiochemical variable
LDL (Low density lipoprotein)Baseline, 7, 14, 21 and 28 daysBiochemical variable
HDL (High density lipoprotein)Baseline, 7, 14, 21 and 28 daysBiochemical variable
TriglyceridesBaseline, 7, 14, 21 and 28 daysBiochemical variable
Fasting GlucoseBaseline, 7, 14, 21 and 28 daysBiochemical variable
Full Blood CountBaseline, 7, 14, 21 and 28 daysBiochemical variable
HeightBaseline, 7, 14, 21 and 28 daysStandard Anthropometric Variables
WeightBaseline, 7, 14, 21 and 28 daysStandard Anthropometric Variables
Ethnic backgroundBaseline, 7, 14, 21 and 28 daysQuestionnaire
Waist CircumferenceBaseline, 7, 14, 21 and 28 daysStandard Anthropometric Variables
Systolic and Diastolic Blood PressureBaseline, 7, 14, 21 and 28 daysStandard Anthropometric Variables
Heart rateBaseline, 7, 14, 21 and 28 daysStandard Anthropometric Variables
Food DiaryBaseline, 7, 14, 21 and 28 daysSelf-reporting
Exercise QuestionnaireBaseline, 7, 14, 21 and 28 daysQuestionnaire
Gene expression of Cytokine GenesBaseline, 7, 14, 21 and 28 daysExtracted PBMCs
ex vivo stimulation of Human Derived Blood CellsBaseline and 28 daysExtracted PBMCs
Hip CircumferenceBaseline, 7, 14, 21 and 28 daysStandard Anthropometric Variables

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026