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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

Primary Purpose

Body Weight, Lipids, Blood Glucose

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flaxseed
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Weight focused on measuring Flaxseed, Weight loss, Heart health, Diabetes

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • CCRC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Soybean oil bar

Flaxseed bar with low lignans

Flaxseed bars with high lignans

Arm Description

A nutrition bar enriched with soybean oil

A nutrition bar enriched with flaxseed oil

A nutrition bar enriched with flaxseed oil and high lignans

Outcomes

Primary Outcome Measures

Improved lipid profile

Secondary Outcome Measures

Full Information

First Posted
July 7, 2009
Last Updated
October 25, 2012
Sponsor
University of California, Davis
Collaborators
Flax Canada 2015 Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00935922
Brief Title
CCRC: Understanding the Effects of Omega-3 Fatty Acids Versus Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis
Collaborators
Flax Canada 2015 Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight, Lipids, Blood Glucose, Insulin
Keywords
Flaxseed, Weight loss, Heart health, Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Soybean oil bar
Arm Type
Placebo Comparator
Arm Description
A nutrition bar enriched with soybean oil
Arm Title
Flaxseed bar with low lignans
Arm Type
Experimental
Arm Description
A nutrition bar enriched with flaxseed oil
Arm Title
Flaxseed bars with high lignans
Arm Type
Experimental
Arm Description
A nutrition bar enriched with flaxseed oil and high lignans
Intervention Type
Dietary Supplement
Intervention Name(s)
Flaxseed
Intervention Description
Flaxseed omega-3 fatty acids and lignans
Primary Outcome Measure Information:
Title
Improved lipid profile
Time Frame
six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidika Kasim-Karakas, MD
Organizational Affiliation
University of California, Davis Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
CCRC
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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