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

Body Weight Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935922
• Other study ID #: 200816799-1
• Status: Completed
• Phase: N/A
• First received: July 7, 2009
• Last updated: October 25, 2012
• Start date: February 2009
• Est. completion date: April 2010

Study information

• Verified date: July 2009
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Glucose
• Body Weight
• Cardiovascular Diseases
• Insulin
• Lipids

Intervention

Dietary Supplement:
• Flaxseed
Flaxseed omega-3 fatty acids and lignans

Locations

Country	Name	City	State
United States	CCRC	Mather	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Flax Canada 2015 Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved lipid profile		six weeks	No