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Trial of Lycopene/Ateronon for Secondary Prevention of Coronary Heart Disease

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ClinicalTrials.gov Identifier: NCT00939237
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : August 19, 2014
Sponsor:
Collaborators:
CamNutra Ltd.
Cambridge Theranostics Ltd
Information provided by (Responsible Party):
Howard D. Sesso, ScD, MPH, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE July 13, 2009
First Posted Date  ICMJE July 14, 2009
Last Update Posted Date August 19, 2014
Study Start Date  ICMJE July 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2009)
Carotid intima-media thickness [ Time Frame: Baseline, 6 months, and 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00939237 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2009)
Biomarkers for coronary heart disease [ Time Frame: Baseline, 6 months, and 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Lycopene/Ateronon for Secondary Prevention of Coronary Heart Disease
Official Title  ICMJE Trial of Ateronon for Carotid Atherosclerosis and Biomarkers in Patients With Stable Coronary Heart Disease
Brief Summary

The purpose of this study is to determine whether Ateronon, a nutritional supplement that contains lycopene from tomatoes has a favorable effect on carotid atherosclerosis, lipid levels, and other biomarkers of coronary heart disease.

The trial was stopped early due to insufficient financial support from the initial study collaborator, Cambridge Theranostics Ltd. Collected patient data are sufficient for final trial-based analyses to be conducted with financial support from the new study collaborator, CamNutra Ltd. The data will still be analyzed according to the original study aims.

Detailed Description Lycopene, a carotenoid mainly found in tomato-based food products, has strong antioxidant properties relative to other carotenoids and has been postulated to play a role in the prevention of coronary heart disease through a variety of mechanisms. Lycopene cooked and consumed in oil mediums is optimal for not only its efficient absorption, but also its potential clinical effectiveness. Studies have also linked serum lycopene with the early stages of atherosclerosis, as measured by carotid artery intima-media thickness (IMT), a noninvasive ultrasound examination of the carotid arteries and potential surrogate endpoint for subsequent cardiovascular morbidity and mortality used in previous clinical trials of vitamin supplements. Short-term intervention studies of lycopene supplements are limited, having explored mechanisms through which lycopene or its readily absorbable food sources may increase plasma lycopene or induce changes in other relevant biochemical markers impacting the subsequent risk of coronary heart disease. Ateronon is a lycopene supplement developed with the understanding that the potential clinical effectiveness of lycopene is impacted by its bioavailability. A single daily 7 mg tablet of Ateronon provides more bioavailable lycopene than diet alone, is absorbed efficiently, and completely inhibits the atherogenic lipid oxidation processes in subjects. Clinical studies suggest that short-term treatment with Ateronon among those with coronary heart disease leads to favorable reductions in lipid levels, lipoprotein oxidation, blood pressure, and Rose-Blackburn scores. Therefore, we will conduct a randomized, double-blind, placebo-controlled clinical trial of 7 mg Ateronon taken daily for 1 year among 200 patients aged ≥50 years with stable coronary heart disease. This clinical trial is a collaborative effort between the Division of Preventive Medicine and the Vascular Medicine Program in the Division of Cardiology. Our primary aim is whether taking Ateronon for 1 year is associated with favorable changes in carotid IMT. Secondary aims expand to whether Ateronon leads to favorable 1-year changes in coronary biomarkers related to oxidative stress and endothelial dysfunction; blood pressure; plasma carotenoids; AtheroAbzyme levels; and other traditional coronary biomarkers. This clinical trial of Ateronon seeks to improve our understanding of various mechanisms through which Ateronon, a concentrated and highly bioavailable form of lycopene, may reduce the risk of developing coronary heart disease.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronary Heart Disease
Intervention  ICMJE
  • Drug: Ateronon
    7 mg lycopene dietary supplement supplied as one Ateronon capsule taken daily
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Active Ateronon
    7 mg lycopene dietary supplement supplied as one Ateronon capsule taken daily
    Intervention: Drug: Ateronon
  • Placebo Comparator: Placebo
    placebo dietary supplement supplied as one capsule taken daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2011)
213
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2009)
200
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Brigham and Women's Hospital Cardiology Clinic patients with history of coronary heart disease occurring at least 6 months ago:

    • history of myocardial infarction (MI) confirmed by medical records AND/OR
    • history of percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG)
  • Compliance during run-in as demonstrated by taking at least 66% of study medications
  • Ability and willingness to complete questionnaires concerning medical history, concomitant medication use, coronary heart disease risk factors, potential adverse events, and diet

Exclusion Criteria:

  • History of carotid stent, carotid endarterectomy, or carotid artery surgery
  • History of diagnosed congestive heart failure meeting New York Association Functional Classification III or IV criteria
  • Any initiation or change in statin use or other lipid-lowering treatment within 3 months of randomization
  • Lactose intolerance
  • Allergies to whey protein
  • Allergies to soy protein
  • History of active cancer diagnosis (except non-melanoma skin cancer) within last 3 years
  • Life expectancy < 1 year
  • Women who are pregnant, nursing, or intend pregnancy during the period of treatment
  • Plan to relocate out of Boston area within the next year
  • Inability to provide informed consent
  • Carotid artery occlusion or dissection at baseline carotid IMT assessment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00939237
Other Study ID Numbers  ICMJE 2009-P-000202 BWH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Howard D. Sesso, ScD, MPH, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE
  • CamNutra Ltd.
  • Cambridge Theranostics Ltd
Investigators  ICMJE
Principal Investigator: Howard D. Sesso, ScD, MPH Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP