Cardiovascular Disease Clinical Trial
Official title:
The Effect of Almonds on Coronary Heart Disease Risk Factors: Dose Response Study.
Verified date | July 2007 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
To assess the effects of almonds on coronary heart disease (CHD) risk factors (serum lipids, measurements of oxidative stress and nitric oxide production) when added to the diets of subjects with high cholesterol. Also, to assess whether the amount of almonds consumed (i.e. almond dose) decreases CHD risk factors in a dose dependent manner. We hypothesize that since almonds have been shown to reduce serum lipids, we believe they will also increase nitric oxide levels related to their high levels of arginine and reduce markers of oxidative stress related to their content of bioactive phenolics. We anticipate that a dose-dependent relationship will be observed resulting in greater reductions in risk factors for coronary heart disease when greater doses of almonds are consumed.
Status | Completed |
Enrollment | 27 |
Est. completion date | September 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Men and post-menopausal women - LDL-C >4.1 mmol/L at recruitment, aged 40-70, living within a 40 km radius of St. Michael's Hospital. Exclusion Criteria: - Lipid lowering medications, clinical or biochemical evidence of diabetes, renal or hepatic disease, body mass index (BMI) >32 kg/m2, antibiotic use within the last three months, hormone replacement therapy, smoking or significant alcohol intake (> 1 drink/d) or triglyceride level >4.0 mmol/L. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto |
Canada,
Jenkins DJ, Kendall CW, Marchie A, Parker TL, Connelly PW, Qian W, Haight JS, Faulkner D, Vidgen E, Lapsley KG, Spiller GA. Dose response of almonds on coronary heart disease risk factors: blood lipids, oxidized low-density lipoproteins, lipoprotein(a), h — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lipids: Total Cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, apolipoproteins B and AI | |||
Primary | Glycemic control: Glucose, insulin, C-peptide (blood and urine). | |||
Secondary | Clotting Factors: fibrinogen, tissue plasminogen activator, plasminogen activator inhibitor, urokinase, factor VII and factor VIII. | |||
Secondary | Oxidative Stress: Oxidized LDL-C as conjugated dienes in isolated LDL-C fraction, serum carotenoids, vitamin E, vitamin A; 8-hydroxy-2-deoxyguanosine (8-HDG) in isolated blood lymphocytes; malondialdehyde (MDA); urinary isoprostanes. | |||
Secondary | Nitric Oxide: Pulmonary (expired air) NO measured as a marker of whole body NO production and olfactory epithelial NO production in perfused nasal air. |
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