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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00935922
Enrollment
36
Registered
2009-07-09
Start date
2009-02-28
Completion date
2010-04-30
Last updated
2012-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Glucose, Body Weight, Insulin, Lipids

Keywords

Flaxseed, Weight loss, Heart health, Diabetes

Brief 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).

Interventions

DIETARY_SUPPLEMENTFlaxseed

Flaxseed omega-3 fatty acids and lignans

Sponsors

Flax Canada 2015 Inc.
CollaboratorINDUSTRY
University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Improved lipid profilesix weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026