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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00935922
Other study ID # 200816799-1
Secondary ID
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


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
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