Trial Outcomes & Findings for Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease (NCT NCT00781950)

NCT ID: NCT00781950

Last Updated: 2016-12-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 110 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2016-12-12

Participant Flow

Participant milestones

Measure	Placebo Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.	Flaxseed 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 Flaxseed: 30 grams of milled flaxseed per day in food products or on its own.
Overall Study STARTED	52	58
Overall Study COMPLETED	41	45
Overall Study NOT COMPLETED	11	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo n=52 Participants Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.	Flaxseed n=58 Participants 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 Flaxseed: 30 grams of milled flaxseed per day in food products or on its own.	Total n=110 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 9.4 • n=5 Participants	67.4 years STANDARD_DEVIATION 8.06 • n=7 Participants	67.3 years STANDARD_DEVIATION 8.5 • n=5 Participants
Gender Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Gender Male	38 Participants n=5 Participants	43 Participants n=7 Participants	81 Participants n=5 Participants
Region of Enrollment Canada	52 participants n=5 Participants	58 participants n=7 Participants	110 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Measure	Placebo n=52 Participants 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.	Flaxseed n=58 Participants 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 Flaxseed: 30 grams of milled flaxseed per day in food products or on its own.
Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions	4 participants	5 participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Placebo n=41 Participants 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.	Flaxseed n=45 Participants 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 Flaxseed: 30 grams of milled flaxseed per day in food products or on its own.
Effects on Exercise Performance, Blood Pressure and Circulating Lipid Levels. Final Systolic Blood Pressure	145.6 mmHg Standard Error 3.4	136.2 mmHg Standard Error 3.8
Effects on Exercise Performance, Blood Pressure and Circulating Lipid Levels. Final Diastolic Blood Pressure	78.5 mmHg Standard Error 1.5	71.8 mmHg Standard Error 1.7

Adverse Events

Placebo

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Flaxseed

Serious events: 15 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=52 participants at risk Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.	Flaxseed n=58 participants at risk 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 Flaxseed: 30 grams of milled flaxseed per day in food products or on its own.
Blood and lymphatic system disorders Increased Claudication	5.8% 3/52 The adverse events were recorded by the research nurse upon follow-up visits.	12.1% 7/58 The adverse events were recorded by the research nurse upon follow-up visits.
Blood and lymphatic system disorders Iliac Artery Stenosis	1.9% 1/52 The adverse events were recorded by the research nurse upon follow-up visits.	0.00% 0/58 The adverse events were recorded by the research nurse upon follow-up visits.
Blood and lymphatic system disorders Rest Pain in Limbs	0.00% 0/52 The adverse events were recorded by the research nurse upon follow-up visits.	3.4% 2/58 The adverse events were recorded by the research nurse upon follow-up visits.
Nervous system disorders Increased Numbess in Extremities	1.9% 1/52 The adverse events were recorded by the research nurse upon follow-up visits.	0.00% 0/58 The adverse events were recorded by the research nurse upon follow-up visits.
General disorders Ulcerative Cellulitis	0.00% 0/52 The adverse events were recorded by the research nurse upon follow-up visits.	1.7% 1/58 The adverse events were recorded by the research nurse upon follow-up visits.
General disorders Death	0.00% 0/52 The adverse events were recorded by the research nurse upon follow-up visits.	1.7% 1/58 The adverse events were recorded by the research nurse upon follow-up visits.
General disorders Stroke	1.9% 1/52 The adverse events were recorded by the research nurse upon follow-up visits.	5.2% 3/58 The adverse events were recorded by the research nurse upon follow-up visits.
Cardiac disorders Myocardial Infarction	5.8% 3/52 The adverse events were recorded by the research nurse upon follow-up visits.	1.7% 1/58 The adverse events were recorded by the research nurse upon follow-up visits.

Other adverse events

Measure	Placebo n=52 participants at risk Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.	Flaxseed n=58 participants at risk 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 Flaxseed: 30 grams of milled flaxseed per day in food products or on its own.
General disorders Nausea	0.00% 0/52 The adverse events were recorded by the research nurse upon follow-up visits.	5.2% 3/58 The adverse events were recorded by the research nurse upon follow-up visits.

Additional Information

Dr. Grant Pierce

St. Boniface Hospital Research Centre

Phone: (204) 235-3414

Email: GPierce@sbrc.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place