COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00939237
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : August 19, 2014
CamNutra Ltd.
Cambridge Theranostics Ltd
Information provided by (Responsible Party):
Howard D. Sesso, ScD, MPH, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Ateronon Drug: Placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial of Ateronon for Carotid Atherosclerosis and Biomarkers in Patients With Stable Coronary Heart Disease
Study Start Date : July 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene

Arm Intervention/treatment
Experimental: Active Ateronon
7 mg lycopene dietary supplement supplied as one Ateronon capsule taken daily
Drug: Ateronon
7 mg lycopene dietary supplement supplied as one Ateronon capsule taken daily

Placebo Comparator: Placebo
placebo dietary supplement supplied as one capsule taken daily
Drug: Placebo

Primary Outcome Measures :
  1. Carotid intima-media thickness [ Time Frame: Baseline, 6 months, and 12 months ]

Secondary Outcome Measures :
  1. Biomarkers for coronary heart disease [ Time Frame: Baseline, 6 months, and 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00939237

Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
CamNutra Ltd.
Cambridge Theranostics Ltd
Layout table for investigator information
Principal Investigator: Howard D. Sesso, ScD, MPH Brigham and Women's Hospital
Layout table for additonal information
Responsible Party: Howard D. Sesso, ScD, MPH, Associate Epidemiologist, Brigham and Women's Hospital Identifier: NCT00939237    
Other Study ID Numbers: 2009-P-000202 BWH
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014
Keywords provided by Howard D. Sesso, ScD, MPH, Brigham and Women's Hospital:
Coronary heart disease
Carotid intima-media thickness
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases