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

University of California (UC) Davis

Status: Completed

Conditions: Lipids; Blood Glucose; Insulin; Body Weight

Treatments: Dietary Supplement: Flaxseed

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00935922

200816799-1

Details and patient eligibility

About

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).

Enrollment: 36 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups, including a placebo group

Soybean oil bar

Placebo Comparator group

Description:

A nutrition bar enriched with soybean oil

Treatment:

Dietary Supplement: Flaxseed

Flaxseed bar with low lignans

Experimental group

Description:

A nutrition bar enriched with flaxseed oil

Treatment:

Dietary Supplement: Flaxseed

Flaxseed bars with high lignans

Experimental group

Description:

A nutrition bar enriched with flaxseed oil and high lignans

Treatment:

Dietary Supplement: Flaxseed