Fish Oil and Biomarkers of Cardiovascular Risk

NCT00527436 | Terminated DMC

• 1 other identifier: 25918
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale Experimental data indicate an inverse relation between intake of omega-3 fatty acids ('fish oil'), primarily in the form of eicosapentanoic acid (EPA) and docosahexanoic acid (DHA), and risk of developing cardiovascular disease in healthy adults. Mechanisms underlying this cardioprotective effect are unknown but may involve favorable influences on various biomarkers of cardiovascular risk. In this project we will determine if these favorable effects of omega-3's occur in older healthy adults, as aging is a primary risk factor for cardiovascular disease development. Key Objectives To determine the effect of chronic (12 week) oral omega-3 fatty acid supplementation on biomarkers of cardiovascular risk in young and older adults. We hypothesize that omega-3 fatty acid supplementation will exert positive effects on biomarkers of cardiovascular risk. Study Population Healthy young (18-40 years of age) and older (50-79) men and women. Major Inclusion \& Exclusion Criteria Subjects must be healthy (as assessed by history and physical examination: non obese BMI\<30: normotensive BP \<140/90 mmHg) men and women not currently taking medications that could influence the results. Women must be non-pregnant. Normal liver enzymes (ALT and AST). Individuals with allergies to corn will be excluded. Allocation to Groups Randomized, double-blinded, and placebo-controlled. Summary of Procedures Measurements will be made at baseline and repeated \~12 weeks after beginning daily oral ingestion of either low dose or high dose fish oil capsules or placebo

Conditions

Cardiovascular Risk Factors

Outcome Measures

Primary Outcomes (7)

• Blood Pressure

  Blood pressure will be measured using a cuff placed around the subject's upper arm as well as a small cuff placed on their finger.

  every 2 weeks for a 12 week duration

• Heart Rate

  Two-inch square adhesive patches will be used to monitor your heart rate

  every two weeks for 12 week duration

• Arterial Pulse Wave Velocity

  The speed at which blood travels through arteries in the subject's torso will be measured non-invasively using Doppler Flow probes.

  every two weeks, for a 12 week duration

• Aortic Blood Pressure

  Aortic Blood pressure will be measured non-invasively by pressing an ultrasound probe against an artery in the neck or wrist.

  every two weeks, for a 12 week duration

• Brachial Artery Blood Flow

  The blood flow into the subject's brachial artery will be measured non-invasively using an ultrasound probe after deflation of a blood pressure cuff that previously had been inflated tightly on the upper forearm for a period of 5 minutes

  every two weeks, for a 12 week duration

• Brachial Artery Blood flow: After Nitroglycerin (0.4mg)

  The blood flow into the subject's brachial artery will be measured non-invasively using an ultrasound probe after placing a pill containing nitroglycerin (0.4mg) under the tongue.

  every two weeks, for a 12 week duration

• Microneurography

  Two very fine, sterile nerve wires (micro-electrodes), thinner than a sewing needle, will be introduced through the skin into a nerve located just under the skin of the right leg. This procedure will measure nerve activity from the brain to the leg.

  every two weeks, for a 12 week duration

Secondary Outcomes (1)

• Blood Withdrawal

  every two weeks, for a 12 week duration

Other Outcomes (1)

• Urine collection

  24 hours

Study Arms (2)

Dietary Supplement

OTHER

Fish oil pill

Dietary Supplement: fish oil

Placebo

PLACEBO COMPARATOR

Placebo matched corn oil pill

Dietary Supplement: Placebo

Interventions

fish oil DIETARY_SUPPLEMENT

Fish oil pills will be taken daily for 12 weeks

Also known as: Omega-3 fatty acids

Dietary Supplement

Placebo DIETARY_SUPPLEMENT

Placebo (corn oil) will be taken daily for 12 weeks

Also known as: corn oil

Placebo

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be healthy (as assessed by history and physical examination:
• Non obese BMI\<30: normotensive BP \<140/90 mmHg) men and women not currently taking medications that could influence the results.
• Women must be non-pregnant.
• Normal liver enzymes (ALT and AST).

You may not qualify if:

• Individuals with allergies to corn will be excluded.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Interventions

Fish Oils; Fatty Acids, Omega-3; Corn Oil

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kevin Monahan, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Double Blind, Placebo Controlled Trial

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

US (1)