NCT00507520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 1999

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2001

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2007

Completed
Last Updated

July 26, 2007

Status Verified

July 1, 2007

First QC Date

July 24, 2007

Last Update Submit

July 25, 2007

Conditions

HyperlipidemiaDiet TherapyCardiovascular Disease

Keywords

RCTAlmondsHyperlipidemiaBlood Lipids

Outcome Measures

Primary Outcomes (2)

  • Lipids: Total Cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, apolipoproteins B and AI

  • Glycemic control: Glucose, insulin, C-peptide (blood and urine).

Secondary Outcomes (3)

  • 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.

Interventions

Full dose almondsPROCEDURE
Half dose almonds+half dose muffinPROCEDURE
Full dose whole wheat muffinPROCEDURE

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5S 2T2, Canada

Location

Related Publications (2)

  • 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), homocysteine, and pulmonary nitric oxide: a randomized, controlled, crossover trial. Circulation. 2002 Sep 10;106(11):1327-32. doi: 10.1161/01.cir.0000028421.91733.20.

    PMID: 12221048RESULT

  • Nishi SK, Kendall CWC, Bazinet RP, Hanley AJ, Comelli EM, Jenkins DJA, Sievenpiper JL. Almond Bioaccessibility in a Randomized Crossover Trial: Is a Calorie a Calorie? Mayo Clin Proc. 2021 Sep;96(9):2386-2397. doi: 10.1016/j.mayocp.2021.01.026. Epub 2021 Apr 11.

    PMID: 33853731DERIVED

MeSH Terms

Conditions

HyperlipidemiasCardiovascular Diseases

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • David JA Jenkins, MD, PhD

    University of Toronto, St. Michael's Hospital

    PRINCIPAL INVESTIGATOR

  • Cyril WC Kendall, PhD

    University of Toronto, St. Michael's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2007

First Posted

July 26, 2007

Study Start

December 1, 1999

Study Completion

September 1, 2001

Last Updated

July 26, 2007

Record last verified: 2007-07

Locations

CA(1)