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

Not Applicable

Completed

• Conditions: Body Weight; Lipids; Blood Glucose; Insulin
• Interventions: Dietary Supplement: Flaxseed

• Registration Number: NCT00935922
• Lead Sponsor: University of California, Davis

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Status Verified: 2009-07
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Last Update Submitted: 2012-10-25
• Last Update Posted: 2012-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soybean oil bar	Flaxseed	A nutrition bar enriched with soybean oil
Flaxseed bar with low lignans	Flaxseed	A nutrition bar enriched with flaxseed oil
Flaxseed bars with high lignans	Flaxseed	A nutrition bar enriched with flaxseed oil and high lignans

Primary Outcome Measures

Name	Time	Method
Improved lipid profile	six weeks

Trial Locations

Locations (1)

CCRC; 🇺🇸 Mather, California, United States