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1 The Journey from Bench to Bedside to Better Living The Integration of Discovery Research with Clinical Research and Industry in Nutraceuticals and Functional Foods Grant N Pierce PhD, FACC, FAHA, FAPS, FISHR, FIACS, FCAHS, Canadian Centre for Agri-food Research in Health and Medicine (CCARM), St. Boniface Hospital Research Centre, University of Manitoba, Winnipeg
2 Can we identify a nutritional intervention in animal studies that can modify a disease process, then confirm this in human research while at the same time creating edible products that may be used ultimately in populations for health benefits and economic advantage?
3 Flaxseed as a nutritional intervention to modify cardiovascular disease
4 Why flaxseed? Because: 1. Epidemiological studies have shown beneficial CV effects of fish omega-3 fatty acids. 2. Epidemiological studies have shown beneficial CV effects of the omega-3 fatty acid alpha linolenic acid (ALA). 3. Flaxseed is one of the richest plant sources of ALA.
5 Our Hypothesis: If we provide ALA through the diet in the form of flaxseed, this may induce beneficial CV effects.
6 What is the epidemiological evidence that ALA may have a significant cardioprotective effect?
7 The Lyon Diet Heart Study Randomized secondary prevention trial Experimental group (302 men and women) consumed typical Mediterranean diet rich in ALA (canola oil margarine) Control group (303 men and women ) consumed typical Western Style Diet 75% reduction in non-fatal myocardial infarctions 70% reduction in total death in experimental group versus control 61% reduction in cancer risk No change in blood cholesterol Results attributed to consumption of ALA rich margarine de Lorgeril, et al Circ. 99:779
8 Health Professionals Follow-Up Study 51,529 health professionals enrolled in study A 1% increase in ALA intake (as % of energy) resulted in a 40% lower risk of non-fatal CHD Br Med J 313:84-90, 1996
9 Clinical data with ALA is mostly indirect but strongly supportive. We do not know the mechanism of action yet. We know little about the use of flaxseed as a delivery vehicle for ALA. How do we proceed?
10 What is the mechanism of action for flaxseed/ala?
11 BENCH
12 Arrhythmias contribute to heart failure. Does flaxseed provide an anti-arrhythmic effect on the ischemic heart?
13 Incidence of ventricular tachycardia and fibrillation during ischemia
14 Atherosclerosis is the primary cause of heart disease. Does flaxseed provide an anti-atherogenic effect in the LDLr KO mouse heart?
15 (A) * * Plasma cholesterol (mg/dl) n * * * RG FX CH CF CF5 CF1 CS
16 Representative pictures of aortas used for enface analysis of atherosclerotic lesion coverage. A: Control; B: Flax C: Cholesterol; D: Cholesterol + Flax
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21 The bench data in animals and the epidemiological data suggest strongly that flaxseed can be used as a therapy for cardiovascular disease. It is possible that it may have a large impact upon human health, quality of life and have a significant economic impact. However, this has not been determined yet. How do we do this?
22 BENCH TO BEDSIDE
23 What DON T we know about the cardiovascular effects of flaxseed in humans? Can ingestion of flaxseed reduce risk factors associated with CVD? Can ingestion of flaxseed/ala inhibit atherosclerosis? Can ingestion of flaxseed correct blood pressure abnormalities? Can ingestion of flaxseed/ala inhibit arrhythmias? Can ingestion of flaxseed/ala alter cardiovascular mortality/morbidity?
24 What we don t know about flaxseed ingestion 1. We don t know how much flaxseed you need to increase your ALA levels in your blood. 2. We don t know which form of flaxseed is best (whole seed, ground seed or oil). 3. We don t know the side-effects of flaxseed ingestion. 4. We don t know if there are sub-populations that react better (or worse) to flaxseed.
25 BEDSIDE We need to provide specific information in smaller, inexpensive trials to guide us when planning the larger trials in clinical populations
26 What is the best form of flaxseed to provide ALA and how quickly does it rise in the blood? Does flaxseed induce side- effects? (g-i( g-i,, bleeding times) Will people eat flaxseed daily for up to 3 months? This is all carried out in a healthy young population.
27 1a ( ] A L A [ a m s a l P !!!!!!!! 0 week 4 weeks 12 weeks 0.00
28 SIDE EFFECTS Whole flaxseed and flax oil induced some g-i side effects that caused subject drop-out. No one dropped out of the ground seed group. There were no changes in platelet aggregation in any of the groups.
29 CONCLUSIONS Ground flaxseed and flax oil deliver ALA optimally. We have finished studying the dose dependent effects of these two products and the difference in the responses of young and elderly subjects. We are now analyzing the data.
30 BENCH TO BEDSIDE TO BETTER LIVING
31 W e are nearing halfway on our trip from bench to bedside to better living. We understand the CV effects better. We understand the side effects better. We understand the delivery vehicle (flaxseed) better. We still need to develop more flaxseed products.
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33 We will embark on a major 2 year clinical trial in the fall of 2007 to be the first to examine the effects of flaxseed in a patient population with cardiovascular disease. This will be a double blinded, placebo controlled randomized clinical trial. The patients suffer from peripheral arterial disease.
34 We will find out if flax decreases heart attacks, stroke and surgical interventions, lowers cholesterol and other fats, decreases arrhythmias and improves exercise performance. We will have tasty, economical nutritional products that will deliver therapeutic doses of flaxseed (hopefully they will be available to everyone).
35 IN THE END, WE WILL HAVE TRAVELLED FROM THE LAB BENCH TO THE PATIENT BEDSIDE ONTO BETTER LIVING FOR ALL OF US
36 MY THANKS TO OUR PARTNERS! Flax Canada; Flax 2015 Canada Bread; Bioriginals Inc AAFC; Cdn International Grain Inst St Boniface Hospital and Research Foundation CIHR; Food Development Centre Manitoba Health Research Council Heart & Stroke Fdn of Manitoba
37 MY THANKS TO THE PEOPLE! Drs Anton Lukas and James Gilchrist Chantal Dupasquier, Amanda Patenaude, Brad Ander, Alex Austria, Andrea Edel, Anna Marie Weber, Mirna Chahine; Elena Dibrov Janice Meseyton; Bruce McKeown; Linda Malcolmson; Tony Tweed; Alphonsus Utioh Don Wilcox; Barry Hall; Kelley Fitzpatrick
38 THANKS FOR YOUR TIME AND YOUR ATTENTION!!!
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