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Clinical Research

Bringing Discoveries to the "Bedside"

Clinical Trials

Canadian Centre for Agri-Food Research in Health and Medicine

Impacting Health Through Translational Research

CCARM regularly recruits healthy and/or patient volunteers to participate in clinical trials. For more information about the kind of research we do, or the kinds of studies for which we are currently recruiting, you may contact the CCARM main office at (204) 237-2570 or email us at ccarm@sbrc.ca or the applicable study coordinator.

Active Studies | Future Studies | Completed Studies


Active Studies

The following clinical trials are currently active and are seeking study participants. Please contact directly the applicable study coordinator for more information about the study you are interested in.

 

A randomized, controlled, cross-over trial examining the effect of peas on post-prandial glucose response in healthy adults.

Principal Investigator: Dr. Heather Blewett (Agriculture and Agri-Food Canada, CCARM)

Brief Description of Study: Volunteers are needed for a food study testing the effect of peas on blood sugar levels after a meal.
We are looking for healthy non-smokers aged 18-40 who are not taking medication or supplements that affect blood pressure/lipids, blood sugar, or digestion. You will be asked to attend a total of 6 clinic visits @ IH Asper Institute between the times of 8AM and 10AM. At each visit, you will be randomly assigned to eat a meal of peas with rice or potato, just rice or potato or just white bread. After the food has been eaten, you will be asked to stay for approximately 2 hours and provide blood samples by finger poke. An Honorarium will be provided for participants.

Contact: 204-258-1209 or peas@sbrc.ca

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Future Studies

Not available at this time.

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Completed Studies

The following studies have been conducted by CCARM and are now concluded.

 

Effects of MS Prebiotic on gut health in the elderly.

Principal Investigator: Dr. Michelle Alfa (University of Manitoba, CCARM).

Brief Description of Study: This study is investigating the efficacy of daily consumption of MS Prebiotic, a natural resistant starch preparation of food grade quality, on gut health in the elderly adults (≥ 70 years of age) as compared to a younger adult (30-50 years of age) cohort. Outcome measures include gut microbial balance, bowel movements, stool consistency and production of short chain fatty acids.

Contact: The Study Coordinator at: 204-258-1230 or email ptappia@sbrc.ca

 

Effects of Canola Oil on Vascular and Metabolic Parameters in Individuals with Metabolic Syndrome

Principal Investigator: Dr. Carla Taylor (University of Manitoba, CCARM);

Co-investigators: Dr. Peter Zahradka (University of Manitoba, CCARM); Dr. Asad Junaid (St. Boniface General Hospital)

Brief Description of Study: This study is designed to examine the effects of canola oil on body fat, metabolic syndrome parameters, and blood vessel function in individuals with metabolic syndrome.

Study Details: A total of 100 participants with at least 2 parameters of metabolic syndrome (elevated triglycerides, low HDL cholesterol, elevated blood glucose, elevated blood pressure, or elevated waist circumference) will participate in a clinical study for 12 weeks. A total of four visits are required for screening, baseline, week 6 and a final Week 12 visit. Upon confirmation of eligibility and signing an informed consent form, participants will be randomly assigned (n=50/group) to one of the following two groups and receive food items containing: a) traditional canola oil, or b) an oil mixture representing the Western diet. Before the baseline visit, participants will complete questionnaires about their food intake, food allergies, and food dislikes/dietary preferences as well as a 3-day food record. Assessments at baseline and week 12 will include blood and urine sampling for evaluation of blood lipids (fats such as triglycerides, HDL and LDL cholesterol) and vascular biomarkers as well as tests for vascular (blood vessel) function. Anthropometrics (height, weight, BMI, waist circumference), and body composition (DEXA scan) will also be done at these visits. At the week 6 visit, blood and urine tests will be repeated along with vascular testing.

Study Status: Recently completed, data currently under review.

 

A Blinded, Randomized, Controlled Study to Examine the Bioavailability of Compounds from Different Bean Varieties in Healthy Individuals (Protocol No. BBB-2014)

Principal Investigator: Dr. Peter Zahradka (University of Manitoba, CCARM)

Co-investigators: Dr. Carla Taylor (University of Manitoba, CCARM)

Brief description of study: This study is investigating the absorption, metabolism and excretion of compounds, blood vessel function and satiety after ingestion of 4 different bean varieties (pinto, navy, red kidney, black) compared to lentils and rice in healthy individuals.

Study Details:
A total of 8 healthy individuals will participate. A total of 7 to 8 clinic visits are required for screening and study visits. Upon confirmation of eligibility and signing an informed consent form, participants will be scheduled for 6 study visits (in the morning) and these visits will be spaced at least 6 days apart. At each study visit, participants will be randomly assigned to consume different bean varieties (4 visits) or lentil (1 visit) or rice (1 visit). Blood and urine samples will be obtained before consumption of the foods, and at various time points over a 6 hour period. After 5 hours, participants will fill out a questionnaire about satiety (feeling hungry or not). Before eating the foods and at 2 and 6 hours after eating them, participants will have their blood vessel function non-invasively monitored with an instrument that will be placed on the upper arm. Each study visit will take approximately 6.5 – 7 hours to complete. A meal voucher and an honorarium will be provided upon completion of each visit.

Study Status: Recently completed, data currently under review.

 

Gender effects of dietary omega-3 fatty acids from plant and marine sources on oxylipins in healthy humans

Principal Investigator: Dr. Carla Taylor (University of Manitoba, CCARM)

Co-investigators: Dr. Harold Aukema (University of Manitoba, CCARM), Dr. Peter Zahradka (University of Manitoba, CCARM)

Brief description of study: This study is investigating the gender effects of omega-3 supplementation on novel fat metabolites (molecules) in the blood and urine of healthy individuals.

Study Details:
A total of six (6) healthy males and six (6) healthy females will participate. A total of 13 to 14 clinic visits are required for screening and study visits. Upon confirmation of eligibility and signing an informed consent form, participants will be scheduled for two 4-week supplementation phases that are spaced at least 6 weeks apart. During each supplementation phase, participants will consume capsules containing omega-3 fats from flax oil or fish oil on a daily basis for 4 weeks. Each supplementation phase will have 6 study visits (in the morning) at 0, 1, 3, 7, 14 and 28 days. At each study visit, fasting blood and urine samples will be collected and participants will fill out a Study Checklist. Each study visit will take approximately ½ hour to complete. During the study, participants will also fill out forms about their food consumption and their physical activity.

Study Status: Recently completed, data currently under review.

 

A dose response, randomized, controlled, double-blind, cross-over trial to determine the LDL cholesterol lowering effect of ground flaxseed in adults with above optimal plasma LDL concentrations

Principal Investigator: Dr. Heather Blewett (Agriculture and Agri-Food Canada, CCARM)

Brief Description of Study:Volunteers are needed to take part in a study of the cholesterol-lowering ability of flax muffins. Participants will be asked to eat 1 muffin every day for 3 phases of 4 weeks each. Visits to the Asper Clinical Research Institute located at St Boniface Hospital (Winnipeg, MB) will be required. Blood and urine samples will be collected. You may be eligible if you are between the ages of 30-65, non-smoker who do not have diabetes and is not taking cholesterol or blood pressure medication.

Study Status: Recently completed, data currently under review.

 

Lentils as a Functional Food to Improve Glucose Tolerance and Decrease Cardiovascular Disease Risk in Hypercholesterolemic Overweight Individuals

Principal Investigator: Dr. Carla Taylor (University of Manitoba)

Co-investigators: Dr. Peter Zahradka (University of Manitoba, CCARM); Dr. Sora Ludwig (St. Boniface Hospital); Dr. Michel Aliani (University of Manitoba)

Study Description: This study is designed to examine the effects of lentils on blood sugar, cholesterol, and blood vessel function in overweight participants. A total of 51 participants will be required to participate in a 12-week study. Visits to the study site will be required for screening, baseline, at Week 6, and at Week 12. Upon confirmation of eligibility and signing an informed consent form, participants will be randomly assigned to 1 of 2 groups and consume: a) foods containing 0.3 cup of cooked lentils each day for the first 5 days, followed by foods containing 0.6 cup of cooked lentils daily for 5 days per week for the remainder of the 12- week schedule, or; b) similar potato-based foods during the 12-week study. Assessments will be done to evaluate blood sugar levels, cholesterol levels, blood vessel function, anthropometrics, and dietary intake. Blood and urine samples will be taken.

Study Status: Recently completed, data currently under review.

 

Substantiating a Health Claim for Pulses (Beans and Peas) and Cholesterol-lowering

Principal Investigator: Dr. Carla Taylor (University of Manitoba)

Co-investigators: Dr. Peter Zahradka (University of Manitoba, CCARM); Dr. Sora Ludwig (St. Boniface Hospital);Dr. Michel Aliani (University of Manitoba)

Brief description of study: This study is designed to examine the effects of beans versus peas versus rice on cholesterol and blood vessel function in men and women with elevated cholesterol. A total of 75 participants will be required to participate in a 6-week study. Visits to the study site will be required for screening, baseline, at Week 3, and at Week 6. Upon confirmation of eligibility and signing an informed consent form, participants will be randomly assigned to 1 of 3 groups and consume: a) foods containing ¾ cup of cooked beans 5 times per week for 6 weeks; or b) ¾ cup of cooked peas 5 times per week for 6 weeks; or c) food items containing ¾ cup of cooked rice 5 times per week for 6 weeks. These foods will be incorporated into the study participant’s normal dietary pattern. Assessments will be done to evaluate blood sugar levels, cholesterol levels, blood vessel function, vitals, and dietary intake. Blood and urine samples will also be taken.

Study Status: Recently completed, data currently under review.

 

Impact of Pulse-enriched Foods on Cognitive Function and Cardiometabolic Health in Obese Adults.

Principal Investigator: Dr. Carla Taylor (University of Manitoba, CCARM)

Co-investigators: Dr. Peter Zahradka (University of Manitoba, CCARM), Dr. Randy Guzman (Section of Vascular Surgery, St. Boniface Hospital), Dr. Peter Howe (University of South Australia) and Dr. Jon Buckley (University of South Australia)

Brief Description of Study: This study is designed to examine the effects of pulses such as beans, peas, lentils, and chickpeas on blood vessel function, thinking, and memory in overweight individuals.

A total of 80 participants will be required to participate in a 12-week study. Visits to the study site will be required for screening, baseline, at Week 6 and Week 12. Upon confirmation of eligibility and signing an informed consent form, participants will be randomly assigned (n=40/group, 2 groups) to consume 1/2 cup per day of foods containing pulses (peas, beans, lentils, and chickpeas), or foods that do not contain pulses but provide the same amount of energy as the pulse foods, along their regular diet. Before the baseline visit, participants will complete questionnaires about their food intake, food dislikes/dietary preferences, and memory/cognition. Participants will be given a 5-day weighed food record and a 5-day physical activity diary to complete before the baseline visit and toward the end of the 12-week study schedule. Assessments at baseline, Week 6 and at the final (Week 12) visits will be done to evaluate blood vessel function, memory/cognition, circulating markers in blood, and anthropometrics. A body scan to determine body fat composition will be required twice: at the beginning and end of the 12-week schedule.

Study Status: Recently completed, data currently under review.

 

A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Corn and Soy Tortillas in Healthy Individuals

Principal Investigator: Dr. Carla Taylor (University of Manitoba, CCARM);

Co-investigators: Dr. Susan Arntfield (University of Manitoba), Dr. Peter Zahradka (University of Manitoba, CCARM)

Brief description of study: This study is investigating whether different levels of soy flour in corn tortillas affects the blood sugar (glycemic) response in healthy individuals.

Study Details: A total of 10 healthy individuals will participate. A total of 7 to 8 clinic visits are required for screening and study visits. Upon confirmation of eligibility and signing an informed consent form, participants will be scheduled for 6 study visits (in the morning) and these visits will be spaced at least 6 days apart. At each study visit, participants will be randomly assigned to consume corn tortillas containing different amounts of soy flour (4 visits) or to drink a solution containing sugar (2 visits). Blood samples will be obtained before consumption of the tortillas or sugar solution, and at various time points over a 2 hour period. After 2 hours, participants will fill out a questionnaire about satiety (feeling hungry or not). Each study visit will take approximately 2.5 – 3 hours to complete.

Study Status: Recently completed, data currently under review.

 

A Randomized, Controlled, Cross-Over Study of the Effect of Snacks on Appetite Control

Principal Investigator: Dr. Heather Blewett

(CCARM)

Brief description of study: Volunteers are needed to take part in a study testing whether eating certain snacks will reduce the desire to eat and for a longer period of time compared to other snacks.

Participants will be given 3 different snacks to eat at 3 different visits. they will answer questions about their appetite. They will be asked to write down what and how much they eat after each visit.

Time Commitment: Visits will take place once per week for 3 weeks at the Asper Clinical Research Institute, 369 Tache Avenue, from 0945AM to 1:30PM. Weekday and weekend visits available.

Study Status: Recently completed, data currently under review.

 

Effects of Pulse Varieties on Blood Vessel Function in Individuals with Peripheral Artery Disease (PAD)

Principal Investigator: Dr. Peter Zahradka (University of Manitoba, CCARM)

Co-investigators: Dr. Carla Taylor (University of Manitoba, CCARM), Dr. Randy Guzman (Section of Vascular Surgery, St. Boniface Hospital, CCARM)

Brief description of Study: This study examined the effects of pulse varieties such as beans, peas, lentils, and chickpeas on blood vessel function in individuals with PAD.

Chronic Phase: 64 participants with PAD participated in study for the duration of 8 weeks. Follow-Up Phase: A subset of 15 participants with PAD (n=5/group, 3 groups) from the Chronic Phase will be assessed at 2, 4, and 8 weeks using similar assessments as the Chronic Phase.

Study Population: PAD participants: male or female, over the age of 40 years, with a confirmed diagnosis of PAD, on a stable medication intake, and no allergies to beans, peas, lentils, and chickpeas.


Study Status Recently completed, data currently under review.

 

Assessment of Three Instruments for the Non-Invasive Measurement of Arterial Stiffness.

Principal Investigator: Dr. Peter Zahradka (University of Manitoba, CCARM)

Co-investigators: Dr. Carla Taylor (University of Manitoba, CCARM), Dr. John Ducas (Section of Cardiology, University of Manitoba)

Brief Description of Study: This research study compared a new experimental non-invasive vascular screening device that measures arterial stiffness via pulse wave contour analysis against other FDA and Health Canada cleared devices that also measure arterial stiffness through pulse wave analysis.


Study Status Recently completed, data currently under review.

 

A Randomized Controlled Trial to Determine the LDL-Cholesterol Lowering Effect of Whole Soy: A Dose Response Study

Principal Investigator: Dr. Heather Blewett (Agriculture and Agri-Food Canada, CCARM)

Brief Description of Study: This multi-centre trial investigated the cholesterol-lowering ability of muffins made from whole soy flour. Participants were asked to eat 2 muffins every day for 6 weeks. The muffins were made with either soy or wheat flour. Participants had weekly visits to the research clinical and blood samples were collected at the beginning, middle and end of the study.

Results from this study are published in: Padhi, EMT., Blewett, HJ., Duncan, AM., Guzman, RP., Hawke, A., Seetharaman, K., Tsao, R., Wolever, TMS., and Ramdath, D.D. (2015) Whole soy flour incorporated into a muffin and consumed at 2 doses of soy protein does not lower LDL cholesterol in a randomized, double-blind controlled trial of hypercholesterolemic adults. J Nutr 145(12):2665-2674. Link:http://jn.nutrition.org/content/145/12/2665.long

Padhi, EM., Ramdath, DD., Carson, SJ., Hawke, A., Blewett, HJ., Wolever, TM., Vella, D., Seetharaman, K., Duizer, LM., Duncan, AM. (2015) Liking of soy flour muffins over time and the impact of a health claim on willingness to consume. Food Research International 77(3):491-7. Link:http://www.sciencedirect.com/science/article/pii/S0963996915301800

 

The Effects of Canola Oil on Blood Vessel Function in Peripheral Arterial Disease (PAD)

Principal Investigator: Dr. Carla Taylor (Department of Nutritional Sciences, University of Manitoba)

Co-Investigators:Dr. Peter Zahradka (University of Manitoba, CCARM) and Dr. R. Guzman (Section of Vascular Surgery, St. Boniface Hospital, CCARM)

Brief Description of Study: This study examined the effects of canola oil on blood vessel function in individuals with PAD. A total of 50 participants with PAD participated in this study for the duration of 8 weeks. There were a total of three visits (screening, baseline and a final Week 8 visit) which participants attended. Upon confirmation of eligibility and signing an informed consent form participants were randomly assigned (n=25/group) to one of the following two groups and received food items containing: a) traditional canola oil, or b) an oil mixture representing the Western diet.

Participants completed questionnaires about their food intake, food allergies, and food dislikes/dietary preferences as well as a 3-day food record. Assessments occurred at baseline and week 8 and included blood vessel function tests, circulating markers in the blood, and anthropometrics.


Study Status Recently completed, data currently under review.

 

The Impact of Egg Consumption on Indices of Vascular Health in Patients with Peripheral Arterial Disease

Principal Investigator: Dr. James D. House (Department of Animal Science, University of Manitoba)

Co-Investigators: Dr. Carla Taylor (University of Manitoba), Dr. Peter Zahradka (University of Manitoba, CCARM), Dr. R. Guzman (St. Boniface Hospital, CCARM), and Dr. Karmin O (University of Manitoba, CCARM).

Brief Description of Study: Eggs, specifically the egg yolk, are a dietary source of cholesterol, but new research suggests that the association between serum cholesterol levels and cardiovascular disease risk is not as strong as previously believed. Furthermore, eggs are an important source of vitamins and other nutrients which could provide important health benefits to individuals with cardiovascular disease. The study was designed to investigate whether there is a link between increased egg consumption and reduction in peripheral artery disease, a form of atherosclerosis that affects

the legs. In addition the researchers investigated whether there is a link between consumption of eggs fortified with Omega-3 fatty acids (fatty acids believed to provide protection against cardiovascular disease) and reduction in peripheral artery disease.


Study Status Recently completed, data currently under review

 

A Double-Blind, Randomized, Controlled Study to Determine Buckwheat’s Glucose Lowering Effects in Healthy Volunteers and Volunteers with Type 2 Diabetes

Principal Investigator: Dr. Peter Zahradka (University of Manitoba, CCARM).

Co-Investigator: Dr. Carla Taylor (University of Manitoba).

Brief Description of Study: This double-blind, randomized, controlled study explored buckwheat’s glucose lowering effects in healthy volunteers and volunteers with type 2 diabetes. There were two phases of this study:

Acute Phase: Study participants were asked to attend 4 visits. A fasting blood sample was collected at each visit. At each visit, the study participants consumed in random order 1 of the following 4 products: i) crackers containing buckwheat; ii) crackers without buckwheat); iii) 296 mls (1⅛ cups) of oral solution containing glucose; or iv) 296 mls (1⅛ cups) of oral solution containing the sugar substitute Splenda.

Chronic Phase: In the chronic testing phase (following the acute testing phase), the same participants (healthy and diabetic) received the crackers containing buckwheat for consumption each day for 7 days. Prior to food consumption, a fasting blood sample was obtained each day and a urine sample will be collected on Days 1, 3, and 7 to assess bioavailability of buckwheat compounds (concentrations in blood and urine), insulin and glucose. Sampling for a lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides), liver (ALT), kidney (creatinine), adipose function (adipokines), various incretins, as well as inflammatory status (various cytokines) on Day 1 and Day 7.

Results from this study are published in: Stringer, D.M., Taylor, C.G., Appah, P., Blewett, H.J., and Zahradka, P. (2013) Consumption of buckwheat modulates the postprandial response of selected gastrointestinal satiety hormones in individuals with type 2 diabetes mellitus. Metabolism 62: 1021-1031. Link

 

The Effect of Dietary Flaxseed on Improving Symptoms of Cardiovascular Disease in Patients with Peripheral Vascular Disease.

Principal Investigator: Dr. Grant Pierce (University of Manitoba, CCARM)

Co-Investigators: Dr. Randy Guzman (Section of Vascular Surgery, St Boniface Hospital, CCARM). Dr. Peter Zahradka (University of Manitoba, CCARM).

Brief Description of Study: The study examined the ability of dietary flaxseed to reduce clinical symptoms of cardiovascular disease and increase exercise tolerance in patients. Rates of complications of cardiovascular disease such as angina, arrhythmias, stroke and heart attacks was tracked over the course of the study and compared to rates in patents not ingesting a flaxseed rich diet.

Beneficial effects on exercise performance, blood pressure and cholesterol levels was also examined.


Study Status Recently completed, some data has been released, see below Free Press article.

See recent Winnipeg Free Press article at: Flaxtastic

 

A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Barley Tortillas in Healthy Volunteers.

Principal Investigator: Dr. Nancy Ames (Agriculture and Agri-Food Canada)

Co-Investigators: Dr. Peter Zahradka (University of Manitoba, CCARM) and Dr. Carla Taylor (University of Manitoba)

Brief Description of Study: This double-blind, randomized, controlled study was examined the effects of barley tortillas on blood glucose in healthy volunteers.

Results from this study are published in: Ames, N., Blewett, H., Storsley, J., Thandapilly, SJ., Zahradka, P., Taylor, C. (2015) A double-blind randomised controlled trial testing the effect of a barley product containing varying amounts and types of fibre on the postprandial glucose response of healthy volunteers. Br J Nutr. 14;113(9):1373-83. Link: http://journals.cambridge.org/download.php?file=%2FBJN%2FBJN113_09%2FS0007114515000367a.pdf&code=544f4829313b7ed69ea5e022a6df2e32

 

Exploring the Health Benefits Associated with Daily Pulse Consumption in Individuals with Peripheral Arterial Disease.

Principal Investigator: Dr. Peter Zahradka (University of Manitoba, CCARM)

Co-Investigators: Dr. Randy Guzman (Section of Vascular Surgery, St Boniface Hospital, CCARM). Dr Carla Taylor (University of Manitoba).

Brief Description of Study: Legumes (peas, lentils, etc) have been linked to positive cardiovascular health based on their fibre content and their blood glucose lowering effects. Legume crops also contain chemicals that have been found to positively affect the cardiovascular system. Until now, few in-depth studies have been performed to investigate these claims. In this study clinical and laboratory tests were used to assess the relationship between the legume diet and changes to blood vessels and their function as they relate to onset of vascular disease. The effects of this diet on the release from fat tissue of hormones shown to prevent atherosclerosis were also examined.

Results from this study are published in: Zahradka, P., Wright, B., Weighell, W., Blewett, H., Baldwin, A., O, K., Guzman, R.P., and Taylor, C.G. (2013) Daily non-soy legume consumption reverses vascular impairment due to peripheral artery disease. Atherosclerosis 230: 310-314. Link

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Institute of Cardiovascular Sciences

Recruitment-Poster-Feb-2014-01-690x677

St. Boniface Hospital

No information at this time.