NCT02670356

Brief Summary

Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are omega-3 fatty acids found in fish oil and in krill oil. The purpose of this study is to compare the effects of the recommended dose of a fish oil supplement (Omax3 4:1 EPA:DHA; recommended daily dose 1650 mg - totaling 1500 mg EPA+DHA) and a krill oil supplement (MegaRed; recommended daily dose 300 mg - totaling 74 mg EPA+DHA) on omega-3 index, plasma biomarkers of inflammation and inflammatory cell activation, and plasma lipid levels in subjects with metabolic syndrome.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

December 23, 2015

Last Update Submit

April 24, 2017

Conditions

InflammationDyslipidemia

Keywords

fish oilEPADHAkrill oilMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Omega-3 index

    red blood cell membrane levels of EPA and DHA, as percent of total fatty acids

    10 weeks

Secondary Outcomes (7)

  • interleukin-6 (IL-6)

    10 weeks

  • Tumor necrosis factor alpha (TNF-alpha)

    10 weeks

  • Monocyte chemoattractant protein 1 (MCP-1)

    10 weeks

  • Total cholesterol

    10 weeks

  • LDL cholesterol

    10 weeks

  • +2 more secondary outcomes

Study Arms (2)

Fish oil

EXPERIMENTAL

fish oil, 1500 mg/day, EPA:DHA ratio of 4:1, each capsule containing 750 mg total EPA+DHA, 2 capsules/day for 10 weeks

Dietary Supplement: Fish oil

krill oil

EXPERIMENTAL

krill oil, 300 mg/day, each capsule containing 74 mg total EPA+DHA , 1 capsule/day for 10 weeks

Dietary Supplement: Krill oil

Interventions

Fish oilDIETARY_SUPPLEMENT

two 750 mg/capsules/day

Fish oil
Krill oilDIETARY_SUPPLEMENT

one 300 mg capsule/day

krill oil

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fasting plasma triglyceride levels between 150 and 500 mg/dL
  • C-reactive protein (CRP) levels ≥2 µg/mL
  • at least one of the following criteria for the definition of metabolic syndrome: abdominal obesity (waist circumference \>40 inches in men and \>35 inches in women), hypertension (blood pressure ≥130/≥85 mmHg or use of anti-hypertensive medications), and fasting glucose ≥110 mg/dL.

You may not qualify if:

  • high-fish diets (\>2 fish meals/week)
  • taking fish oil supplements or supplements containing EPA or DHA
  • regular use of anti-inflammatory medications
  • Above normal coagulation time or use of anticoagulant medications
  • allergy to fish, fish oil, or shellfish
  • uncontrolled thyroid dysfunction
  • insulin-dependent type 2 diabetes mellitus
  • kidney or liver disease
  • smoking
  • drinking more than 7 alcoholic drinks/week
  • use of lipid-lowering medications or medications known to alter lipoprotein metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Mayer Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

InflammationDyslipidemiasMetabolic Syndrome

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Stefania Lamon-Fava, Ph.D.

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist I. Associate Professor

Study Record Dates

First Submitted

December 23, 2015

First Posted

February 1, 2016

Study Start

October 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 26, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)