NCT01896414

Brief Summary

The metabolic syndrome raises the risk of heart disease and is currently at epidemic proportions in the U.S. It consists of 3 of the following components: central obesity, high triglycerides, low HDL, abnormal blood pressure and impaired fasting glucose levels. Previous studies have suggested that omega-3 fish oil may influence some of these components but the mechanisms involved are not well understood. Therefore, this proposal will investigate how omega-3 fish oils affect inflammation, lipids and fat breakdown by comparing it to placebo. Favorable outcomes from this study could translate into a new approach to improve heart disease risk in men and women with the metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

June 18, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2016

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

June 18, 2013

Last Update Submit

January 10, 2020

Conditions

Metabolic Syndrome

Keywords

Metabolic SyndromeOmega 3 Fish Oil

Outcome Measures

Primary Outcomes (1)

  • Biochemical measurements of lipids, glucose homeostasis, inflammatory markers, and adipocyte responses to mediators of lipolysis

    Metabolic (e.g., lipoproteins, inflammatory cytokines, acute phase reactants, glucose tolerance/insulin resistance) and adipose tissue responses (basal and insulin suppression of lipolysis (ED50), LPL activity, cytokine release and lipogenesis).

    Up to 2 years

Secondary Outcomes (1)

  • Determination of regional fat distribution, visceral and subcutaneous adipose volume and body composition

    Up to 2 years

Study Arms (2)

EPA (marine fatty acids)

EXPERIMENTAL

Subjects will receive EPA , four 1 gram capsules daily.

Dietary Supplement: EPA (marine fatty acids)

Placebo

PLACEBO COMPARATOR

Subjects will be randomized to receive placebo, four 1 gram capsules daily.

Dietary Supplement: Placebo

Interventions

EPA (marine fatty acids)DIETARY_SUPPLEMENT

Subjects will be randomized to receive either EPA or placebo, four 1 gram capsules daily.

EPA (marine fatty acids)
PlaceboDIETARY_SUPPLEMENT

Subjects will be randomized to receive either EPA/ or placebo, four 1 gram capsules daily.

Placebo

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metabolic Syndrome, including 2 of the following:
  • Treated Hyperlipidemia or Untreated Triglycerides \> 150 mg/dL
  • Waist circumference (inches) \> 35 (women) or \>40 (men)
  • And at least 1 additional factor:
  • Treated Hypertension or Untreated Blood pressure \>130/85 and \< 160/100 mm Hg
  • HDL-C \< 40 mg/dL men \< 50 mg/dL women
  • Glucose \> 100mg/dL and HbA1c \< 6.1%

You may not qualify if:

  • Fasting TG \> 500 mg/dL or LDL \> 180 mg/dL
  • Fasting glucose\> 125 mg/dL or history of diabetes mellitus
  • Hematologic or malignant disorders
  • Morbid Obesity (BMI \> 50 kg/m2)
  • Endocrine (thyroid) or metabolic disorders (unless treated and under control)
  • Alcohol consumption greater than (2) 4-ounce glasses of table wine, (2) 12-oz bottles of beer or 2 shots of spirits in men or women
  • Active IV drug abuse within the past 6 months
  • Clinical depression (per PI evaluation)
  • Immunosuppressive or other therapy that would interfere with research testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Amish Research Center

Lancaster, Pennsylvania, 17601, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Michael Miller, M.D.

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

June 18, 2013

First Posted

July 11, 2013

Study Start

July 1, 2014

Primary Completion

May 30, 2016

Study Completion

May 30, 2016

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

US(2)