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Sponsored by: |
University of Toronto |
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Information provided by: | University of Toronto |
ClinicalTrials.gov Identifier: | NCT00507520 |
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.
Condition | Intervention | Phase |
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Hyperlipidemia Diet Therapy Cardiovascular Disease |
Procedure: Full dose almonds Procedure: Half dose almonds+half dose muffin Procedure: Full dose whole wheat muffin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | The Effect of Almonds on Coronary Heart Disease Risk Factors: Dose Response Study. |
Enrollment: | 27 |
Study Start Date: | December 1999 |
Study Completion Date: | September 2001 |
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
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 |
Study ID Numbers: | REB 235U, U of T Protocol #6440 |
Study First Received: | July 24, 2007 |
Last Updated: | July 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00507520 History of Changes |
Health Authority: | Canada: Health Canada |
RCT Almonds Hyperlipidemia Blood Lipids |
Coronary Disease Metabolic Diseases Hyperlipidemias Heart Diseases |
Metabolic Disorder Dyslipidemias Coronary Artery Disease Lipid Metabolism Disorders |
Metabolic Diseases Hyperlipidemias Cardiovascular Diseases Dyslipidemias Lipid Metabolism Disorders |