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Almond Dose Response Study.

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ClinicalTrials.gov Identifier: NCT00507520
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : July 26, 2007
Sponsor:
Information provided by:
University of Toronto

Brief Summary:
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 or disease Intervention/treatment Phase
Hyperlipidemia Diet Therapy Cardiovascular Disease Procedure: Full dose almonds Procedure: Half dose almonds+half dose muffin Procedure: Full dose whole wheat muffin Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Effect of Almonds on Coronary Heart Disease Risk Factors: Dose Response Study.
Study Start Date : December 1999
Actual Study Completion Date : September 2001



Primary Outcome Measures :
  1. Lipids: Total Cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, apolipoproteins B and AI
  2. Glycemic control: Glucose, insulin, C-peptide (blood and urine).

Secondary Outcome Measures :
  1. Clotting Factors: fibrinogen, tissue plasminogen activator, plasminogen activator inhibitor, urokinase, factor VII and factor VIII.
  2. 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.
  3. 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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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507520


Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5S 2T2
Sponsors and Collaborators
University of Toronto
Investigators
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

Publications of Results:
ClinicalTrials.gov Identifier: NCT00507520     History of Changes
Other Study ID Numbers: REB 235U
U of T Protocol #6440
First Posted: July 26, 2007    Key Record Dates
Last Update Posted: July 26, 2007
Last Verified: July 2007

Keywords provided by University of Toronto:
RCT
Almonds
Hyperlipidemia
Blood Lipids

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases