Investigating the Effect of 4-week Omega-3 Polyunsaturate... | NCT03210805

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

NCT03210805

Sponsor

Bethan Hussey

Status

Unknown status

Last Update Posted

Jul 7, 2017Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Omega-3 Polyunsaturated Fatty Acids Supplementation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 9, 2017Actual

Primary Completion Date

Aug 2017Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Jul 4, 2017

First Submission Date that Met QC Criteria

Jul 5, 2017

First Posted Date

Jul 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2017

Last Update Posted Date

Jul 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supplementation	Experimental	Omega-3 Polyunsaturated Fatty Acids	Dietary Supplement: Omega-3 Polyunsaturated Fatty Acids Supplementation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega-3 Polyunsaturated Fatty Acids Supplementation	Dietary Supplement	28 days of a commercially available supplement. 4 capsules per day.	Supplementation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Epigenetic regulation of Cytokine Genes	Blood Sample	Change from Baseline at 7, 14, 21 and 28 days

Secondary Outcomes

Measure	Description	Time Frame
Total Cholesterol	Biochemical variable	Baseline, 7, 14, 21 and 28 days
LDL (Low density lipoprotein)	Biochemical variable	Baseline, 7, 14, 21 and 28 days

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided