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

NCT ID: NCT00935922

Last Updated: 2012-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Body Weight Lipids Blood Glucose Insulin

Keywords

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Flaxseed Weight loss Heart health Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Soybean oil bar

A nutrition bar enriched with soybean oil

Group Type PLACEBO_COMPARATOR

Flaxseed

Intervention Type DIETARY_SUPPLEMENT

Flaxseed omega-3 fatty acids and lignans

Flaxseed bar with low lignans

A nutrition bar enriched with flaxseed oil

Group Type EXPERIMENTAL

Flaxseed

Intervention Type DIETARY_SUPPLEMENT

Flaxseed omega-3 fatty acids and lignans

Flaxseed bars with high lignans

A nutrition bar enriched with flaxseed oil and high lignans

Group Type EXPERIMENTAL

Flaxseed

Intervention Type DIETARY_SUPPLEMENT

Flaxseed omega-3 fatty acids and lignans

Interventions

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Flaxseed

Flaxseed omega-3 fatty acids and lignans

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Flax Canada 2015 Inc.

INDUSTRY

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Sidika E. Karakas, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sidika Kasim-Karakas, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis Health System

Locations

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CCRC

Mather, California, United States

Site Status

Countries

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United States

Other Identifiers

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200816799-1

Identifier Type: -

Identifier Source: org_study_id