Almond Dose Response Study.
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.
Procedure: Full dose almonds
Procedure: Half dose almonds+half dose muffin
Procedure: Full dose whole wheat muffin
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||The Effect of Almonds on Coronary Heart Disease Risk Factors: Dose Response Study.|
- Lipids: Total Cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, apolipoproteins B and AI
- Glycemic control: Glucose, insulin, C-peptide (blood and urine).
- Clotting Factors: fibrinogen, tissue plasminogen activator, plasminogen activator inhibitor, urokinase, factor VII and factor VIII.
- 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.
- Nitric Oxide: Pulmonary (expired air) NO measured as a marker of whole body NO production and olfactory epithelial NO production in perfused nasal air.
|Study Start Date:||December 1999|
|Study Completion Date:||September 2001|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507520
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5S 2T2|
|Principal Investigator:||David JA Jenkins, MD, PhD||University of Toronto, St. Michael's Hospital|
|Study Director:||Cyril WC Kendall, PhD||University of Toronto, St. Michael's Hospital|