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

NCT00935922 | Completed DMC

• 1 other identifier: 200816799-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Body Weight; Lipids; Blood Glucose; Insulin

Keywords

Flaxseed; Weight loss; Heart health; Diabetes

Outcome Measures

Primary Outcomes (1)

• Improved lipid profile

  six weeks

Study Arms (3)

Soybean oil bar

PLACEBO COMPARATOR

A nutrition bar enriched with soybean oil

Dietary Supplement: Flaxseed

Flaxseed bar with low lignans

EXPERIMENTAL

A nutrition bar enriched with flaxseed oil

Dietary Supplement: Flaxseed

Flaxseed bars with high lignans

EXPERIMENTAL

A nutrition bar enriched with flaxseed oil and high lignans

Dietary Supplement: Flaxseed

Interventions

Flaxseed DIETARY_SUPPLEMENT

Flaxseed omega-3 fatty acids and lignans

Flaxseed bar with low lignans; Flaxseed bars with high lignans; Soybean oil bar

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or postmenopausal women in the 40-65 years age range. Body Mass Index in the range of 25-39

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Flax Canada 2015 Inc.: collaborator

Study Sites (1)

CCRC

Mather, California, 95655, United States

Location

MeSH Terms

Conditions

Body Weight; Insulin Resistance; Weight Loss; Diabetes Mellitus

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Weight Changes; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Sidika Kasim-Karakas, MD

  University of California, Davis Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 9, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 29, 2012

Record last verified: 2009-07

Locations

US (1)