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

This study is currently recruiting participants.

Verified by University of California, Davis, July 2009

First Received: July 7, 2009 Last Updated: July 8, 2009 History of Changes

Sponsor:	University of California, Davis
Collaborator:	Flax Canada 2015 Inc.
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00935922

Purpose

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).

Condition	Intervention
Body Weight Lipids Blood Glucose Insulin	Dietary Supplement: Flaxseed

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	CCRC: Understanding the Effects of Omega-3 Fatty Acids vs. Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diets

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

Improved lipid profile [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	February 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Soy bar: No Intervention	Dietary Supplement: Flaxseed Flaxseed omega-3 fatty acids and lignans
Flaxseed bar with low lignans: No Intervention	Dietary Supplement: Flaxseed Flaxseed omega-3 fatty acids and lignans
Flaxseed bars with high lignans: No Intervention	Dietary Supplement: Flaxseed Flaxseed omega-3 fatty acids and lignans

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935922

Contacts

Contact: Sidika Karakas, MD

916-734-4747

flaxstudy@gmail.com

Locations

United States, California
CCRC	Recruiting
Mather, California, United States, 95655
Contact: Nancy Fitch, RN 916-843-9436
Principal Investigator: Sidika Karakas, MD

Sponsors and Collaborators

University of California, Davis

Flax Canada 2015 Inc.

Investigators

Principal Investigator:

Sidika Kasim-Karakas, MD

University of California, Davis Health System

More Information

No publications provided

Responsible Party:	University of California, Davis ( Sidika Kasim-Karakas, MD )
Study ID Numbers:	200816799-1
Study First Received:	July 7, 2009
Last Updated:	July 8, 2009
ClinicalTrials.gov Identifier:	NCT00935922 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

Flaxseed
Weight loss
Heart health
Diabetes

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010