Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease

NCT00781950 | Completed Phase 2 Results DMC

• 1 other identifier: 10941-011
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Clinical Trial is being conducted to study how patients with peripheral arterial disease (a condition in which the blood vessels of the extremities are affected) respond to a dietary regimen of flaxseed. The purpose of the study is to examine whether or not dietary flaxseed have any effect on improving symptoms of cardiovascular disease. Additionally, the effects of dietary flaxseed on exercise tolerance will be assessed.

Conditions

Peripheral Arterial Disease

Keywords

PAD; Peripheral Arterial Disease; Diabetes; Atherosclerosis; Flax; Flaxseeds; Functional Foods; Essential Fatty Acids; Winnipeg

Outcome Measures

Primary Outcomes (1)

• Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions

  1 year

Secondary Outcomes (1)

• Effects on Exercise Performance, Blood Pressure and Circulating Lipid Levels.

  1 year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat and wheat bran to replace the flaxseed daily for one year.

Dietary Supplement: Placebo

Flaxseed

EXPERIMENTAL

Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year

Dietary Supplement: Flaxseed

Interventions

Flaxseed DIETARY_SUPPLEMENT

30 grams of milled flaxseed per day in food products or on its own.

Flaxseed

Placebo DIETARY_SUPPLEMENT

Wheat and Mixed Dietary Oils

Placebo

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with peripheral arterial disease for more than 6 months.
• Male or female with claudication secondary to lower extremity atherosclerotic arterial disease. (with limited IC but not incapacitated for walking on the level) confirmed with ankle/brachial pressures\< or = to 0.9 in one or both legs) or who have had a previous intervention for peripheral arterial disease.
• Over 40 years old
• Able to comply with protocol requirements
• Able to provide informed consent
• Subjects taking anti-platelet therapy medication must be on a stable dose for 3 months prior to as well as during the study.
• Subjects taking lipid lowering medication must be on a stable dose for 3 months prior to as well as during the study.

You may not qualify if:

• Patients with ischemic rest pain in limbs, ulceration, or gangrene.
• At baseline, any condition that prevents walking on a treadmill.
• History of major bleeding.
• Patients with bowel disease (including Crohn's disease, celiac disease, peptic ulcer disease, irritable bowel syndrome and diverticulosis).
• Patients with an estimated life expectancy less than 2 years and with high baseline cardiac risk (post ischemic or diabetic cardiomyopathy with EF\<40%, Canadian Cardiovascular Society Class 3 or 4 angina or need for coronary revascularization procedures).
• Moderate to severe renal failure.
• Subjects that are on supplements other that those prescribed by their clinician for the entire duration of the study.
• Fish limitations (no more than 2 fish meals per week)
• Gluten allergy
• Subjects with allergies to any ingredient in the study product or placebo.
• Patients who plan to undergo surgery during the course of the trial.

Sponsors & Collaborators

• Dr. Grant Pierce: lead

Related Publications (3)

• Caligiuri SP, Rodriguez-Leyva D, Aukema HM, Ravandi A, Weighell W, Guzman R, Pierce GN. Dietary Flaxseed Reduces Central Aortic Blood Pressure Without Cardiac Involvement but Through Changes in Plasma Oxylipins. Hypertension. 2016 Oct;68(4):1031-8. doi: 10.1161/HYPERTENSIONAHA.116.07834. Epub 2016 Aug 15.

  PMID: 27528063 DERIVED

• Edel AL, Rodriguez-Leyva D, Maddaford TG, Caligiuri SP, Austria JA, Weighell W, Guzman R, Aliani M, Pierce GN. Dietary flaxseed independently lowers circulating cholesterol and lowers it beyond the effects of cholesterol-lowering medications alone in patients with peripheral artery disease. J Nutr. 2015 Apr;145(4):749-57. doi: 10.3945/jn.114.204594. Epub 2015 Feb 18.

  PMID: 25694068 DERIVED

• Caligiuri SP, Aukema HM, Ravandi A, Guzman R, Dibrov E, Pierce GN. Flaxseed consumption reduces blood pressure in patients with hypertension by altering circulating oxylipins via an alpha-linolenic acid-induced inhibition of soluble epoxide hydrolase. Hypertension. 2014 Jul;64(1):53-9. doi: 10.1161/HYPERTENSIONAHA.114.03179. Epub 2014 Apr 28.

  PMID: 24777981 DERIVED

Related Links

• Canadian Centre for Agri-food Research in Health and Medicine

MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetes Mellitus; Atherosclerosis

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Grant Pierce
• Organization: St. Boniface Hospital Research Centre

GPierce@sbrc.ca

(204) 235-3414

Study Officials

• Grant Pierce, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director, Research Enterprise

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: October 1, 2016
• Last Updated: December 12, 2016
• Results First Posted: December 12, 2014

Record last verified: 2016-10