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

Sponsor

University of California, Davis (Other)

Overall Status

Completed

CT.gov ID

NCT00935922

Collaborator

Flax Canada 2015 Inc. (Industry)

Enrollment

Location

Arms

13.9

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Body Weight Lipids Blood Glucose Insulin	Dietary Supplement: Flaxseed	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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.

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Improved lipid profile [six weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	CCRC	Mather	California	United States	95655

Sponsors and Collaborators

University of California, Davis
Flax Canada 2015 Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sidika E. Karakas, MD, Professor, University of California, Davis

ClinicalTrials.gov Identifier:

NCT00935922

Other Study ID Numbers:

200816799-1

First Posted:

Jul 9, 2009

Last Update Posted:

Oct 29, 2012

Last Verified:

Jul 1, 2009

Keywords provided by Sidika E. Karakas, MD, Professor, University of California, Davis

Additional relevant MeSH terms:

Cardiovascular Diseases

Body Weight

Study Results

No Results Posted as of Oct 29, 2012