CCRC: Understanding the Effects of Omega-3 Fatty Acids Versus 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).

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Key information

Conditions

Body Weight Blood Glucose Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Insulin Resistance Lipids Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CCRC

Mather, California, 95655, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flaxseed

Dietary Supplement

Flaxseed omega-3 fatty acids and lignans

Primary outcomes

Improved lipid profile

Time frame: six weeks

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

Flax Canada 2015 Inc.

Registry information

Official study 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.

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jul 9, 2009
Registry last updated: Oct 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed