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Almond Dose Response Study.

This study has been completed.
Sponsor:
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00507520
First received: July 24, 2007
Last updated: July 25, 2007
Last verified: July 2007
History of Changes
  Purpose

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
Hyperlipidemia
Diet Therapy
Cardiovascular Disease
 Procedure: Full dose almonds
Procedure: Half dose almonds+half dose muffin
Procedure: Full dose whole wheat muffin
 Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Toronto:

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

Secondary Outcome Measures:
  • 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.

Enrollment: 27
Study Start Date: December 1999
Study Completion Date: September 2001
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00507520     History of Changes
Other Study ID Numbers: REB 235U, U of T Protocol #6440
Study First Received: July 24, 2007
Last Updated: July 25, 2007
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Disease
Hyperlipidemias
Myocardial Ischemia
Heart Diseases
 Vascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013