NCT02670382

Brief Summary

The objective of this study is to provide critical information regarding both common and distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

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
29 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
7 months until next milestone

Results Posted

Study results publicly available

April 14, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

4.2 years

First QC Date

December 23, 2015

Results QC Date

February 26, 2021

Last Update Submit

April 13, 2021

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (3)

  • Interleukin-6 (IL-6)

    plasma levels in pg/mL

    10 weeks

  • Tumor Necrosis Factor Alpha (TNF-alpha)

    plasma levels in pg/mL

    10 weeks

  • Low Density Lipoprotein Cholesterol (LDL-C)

    plasma levels in mg/dL

    10 weeks

Study Arms (3)

EPA intervention

EXPERIMENTAL

Subjects randomized to receive 3000 mg EPA/day, provided as EPA 750 mg/capsule will be instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.

Dietary Supplement: EPA

DHA intervention

EXPERIMENTAL

Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.

Dietary Supplement: DHA

Placebo

PLACEBO COMPARATOR

3000 mg high oleic acid sunflower oil/day; 750 mg high oleic acid sunflower oil/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals during 4 week long lead-in phase.

Dietary Supplement: sunflower oil

Interventions

EPADIETARY_SUPPLEMENT

10 week supplementation

Also known as: eicosapentaenoic acid
EPA intervention
DHADIETARY_SUPPLEMENT

10 week supplementation

DHA intervention
sunflower oilDIETARY_SUPPLEMENT

4-week lead-in

Placebo

Eligibility Criteria

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

You may qualify if:

  • fasting plasma TG 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
  • allergy to sardines
  • allergy to sunflower oil
  • regular use of anti-inflammatory medications (NSAID, COX inhibitors, corticosteroids)
  • anticoagulant therapy
  • alcohol consumption \>7 drinks/week
  • uncontrolled thyroid dysfunction
  • insulin-dependent type 2 diabetes mellitus
  • kidney or liver disease
  • smoking
  • alterations in coagulation
  • use of lipid altering medications

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

Metabolic Syndrome

Interventions

Eicosapentaenoic AcidSunflower Oil

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsEicosanoidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsPlant OilsPlant PreparationsBiological ProductsComplex Mixtures

Results Point of Contact

Title
Dr. Stefania Lamon-Fava, Scientist I
Organization
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
stefania.lamon-fava@tufts.edu
617-556-3105

Study Officials

  • Stefania Lamon-Fava, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
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

March 1, 2016

Primary Completion

May 1, 2020

Study Completion

October 1, 2020

Last Updated

April 14, 2021

Results First Posted

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

The objective of this study is to provide critical information regarding both common and distinctive roles of the omega-3 fatty acids EPA and DHA in systemic inflammation and lipid metabolism.

Locations

US(1)