CCRC: Understanding the Effects of Omega-3 Fatty Acids Versus Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease

October 25, 2012 updated by: Sidika E. Karakas, MD, University of California, Davis

CCRC: Understanding the Effects of Omega-3 Fatty Acids vs. Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease.

The aim of this study is to compare the effects of flaxseed on atherogenic lipids, plasma inflammatory markers, and insulin sensitivity.

We hypothesize that flaxseed omega-3 fatty acids will improve the lipid profile (decrease triglyceride, total and LDL-cholesterol and increase HDL-cholesterol).

Flaxseed is the richest dietary source of lignan secoisolariciresinol diglucoside (SDG). Lignans are estrogens found in plant sources that behave similar to endogenous estrogens and have been associated with cardiovascular benefits due to their antioxidant activity. Therefore, we also hypothesize that flax-lignans will cause a significant decrease in LDL oxidation and in inflammatory markers such as C-reactive protein (CRP), interleukin-6 (IL-6), IL-1B, serum fatty acid binding protein 4 (FABP-4), and serum amyloid attached to high density lipoprotein (HDL-SAA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mather, California, United States, 95655
        • CCRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or postmenopausal women in the 40-65 years age range. Body Mass Index in the range of 25-39

Exclusion Criteria:

  • Women are are premenopausal
  • Smoking
  • Diabetes
  • Cancer
  • Gout
  • Untreated thyroid disease
  • Kidney Disease
  • Liver Disease
  • Use of lipid lowering drugs
  • Use of insulin sensitizing drugs
  • Use of ACE inhibitors or other blood pressure lowering medications
  • Use of over the counter or prescription anti-obesity medications
  • Weight loss of 10% or more within the last 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Soybean oil bar
A nutrition bar enriched with soybean oil
Dietary supplement: Flaxseed
Flaxseed omega-3 fatty acids and lignans
Experimental: Flaxseed bar with low lignans
A nutrition bar enriched with flaxseed oil
Dietary supplement: Flaxseed
Flaxseed omega-3 fatty acids and lignans
Experimental: Flaxseed bars with high lignans
A nutrition bar enriched with flaxseed oil and high lignans
Dietary supplement: Flaxseed
Flaxseed omega-3 fatty acids and lignans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improved lipid profile
Time Frame: six weeks
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Flax Canada 2015 Inc.

Investigators

  • Principal Investigator: Sidika Kasim-Karakas, MD, University of California, Davis Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

July 7, 2009

First Submitted That Met QC Criteria

July 8, 2009

First Posted (Estimate)

July 9, 2009

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200816799-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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