NCT00939237

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2009

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

July 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

August 19, 2014

Status Verified

August 1, 2014

Enrollment Period

1.8 years

First QC Date

July 13, 2009

Last Update Submit

August 15, 2014

Conditions

Coronary Heart Disease

Keywords

Coronary heart diseaseCarotid intima-media thicknessBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Carotid intima-media thickness

    Baseline, 6 months, and 12 months

Secondary Outcomes (1)

  • Biomarkers for coronary heart disease

    Baseline, 6 months, and 12 months

Study Arms (2)

Active Ateronon

EXPERIMENTAL

7 mg lycopene dietary supplement supplied as one Ateronon capsule taken daily

Drug: Ateronon

Placebo

PLACEBO COMPARATOR

placebo dietary supplement supplied as one capsule taken daily

Drug: Placebo

Interventions

AterononDRUG

7 mg lycopene dietary supplement supplied as one Ateronon capsule taken daily

Active Ateronon
PlaceboDRUG
Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Howard D. Sesso, ScD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Epidemiologist

Study Record Dates

First Submitted

July 13, 2009

First Posted

July 14, 2009

Study Start

July 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 19, 2014

Record last verified: 2014-08

Locations

US(1)