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

This study has been completed.
Sponsor:
Collaborators:
CamNutra Ltd.
Cambridge Theranostics Ltd
Information provided by (Responsible Party):
Howard D. Sesso, ScD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00939237
First received: July 13, 2009
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Coronary Heart Disease
Drug: Ateronon
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial of Ateronon for Carotid Atherosclerosis and Biomarkers in Patients With Stable Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Carotid intima-media thickness [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biomarkers for coronary heart disease [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]

Enrollment: 213
Study Start Date: July 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939237

Locations
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
Investigators
Principal Investigator: Howard D. Sesso, ScD, MPH Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Howard D. Sesso, ScD, MPH, Associate Epidemiologist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00939237     History of Changes
Other Study ID Numbers: 2009-P-000202 BWH
Study First Received: July 13, 2009
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Coronary heart disease
Carotid intima-media thickness
Biomarkers

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014