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Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use (GSPE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707615
First Posted: October 16, 2012
Last Update Posted: October 16, 2012
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.
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Jie Qiu, Shandong University
  Purpose
The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical use

Condition Intervention Phase
Atherosclerosis of Arteries of the Extremities, Unspecified Drug: GSPE Other: lifestyle intervention Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Carotid Intima-media Thickness and Atherosclerotic Plaques in Clinical Use

Resource links provided by NLM:


Further study details as provided by Jie Qiu, Shandong University:

Primary Outcome Measures:
  • Carotid B-Mode Ultrasound [ Time Frame: Carotid ultrasound examination was performed at baseline and 6, 12, 24months after treatment.The change of carotid plaque was record within 24 months. ]
    The common, internal, and external carotid arteries were carefully identified by combining B-mode ultrasonography and color-Doppler duplex examination in the anterior oblique, lateral, and posterior oblique planes. All data was collected in 12 segments: the near (intimal-luminal surface) and far (medial- adventitial) walls of the distal common (1 cm proximal to dilation of the carotid bulb), the bifurcation (1cm proximal to the flow divider), and the proximal internal (1 cm section of the internal carotid artery immediately distal to the flow divider) left and right carotid artery.


Secondary Outcome Measures:
  • clinical vascular events [ Time Frame: after 24 months follow-up ]
    including hospital readmission for unstable angina, myocardial infarction, stroke, TIA, an arterial revascularization procedure (percutaneous coronary revascularization or coronary bypass surgery) and cardiac death.


Enrollment: 287
Study Start Date: October 2006
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
control group
In the control group, all patients were enrolled in a lifestyle intervention
Other: lifestyle intervention
dietary modification making the total ingestion of calories into standard body weight 25 kCal in effect and an individualized home exercise program of a minimum 150 min/week of moderate-intensity physical activity
Active Comparator: GSPE group
GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.
Drug: GSPE
GSPE 240 mg/day (120mg bid)
Other Name: Grape seed proanthocyanidin extrat
Other: lifestyle intervention
dietary modification making the total ingestion of calories into standard body weight 25 kCal in effect and an individualized home exercise program of a minimum 150 min/week of moderate-intensity physical activity

Detailed Description:
Atherosclerotic plaques indicate the occurrence of ischemia events and how to deal with it is a difficult task for clinical physicians. Grape seed proanthocyanidin extrat (GSPE) has been reported to exert an antiatherogenic effect by inducing regression of atherosclerotic plaques in animal experimental studies. In this study, the antiatherogenic effect of GSPE has been investigated in clinical use.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   43 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) carotid ultrasound examination: presence of carotid plaque or abnormal CIMT of between 0.9 and 1.2mm; (2) lipid profile: LDL≦3.12mmol/L, TC≦5.2mmol/L; (3) no lipid-lowering treatment within the past 6 months.

Exclusion Criteria:

  • severe cardiomyopathy, acute coronary syndrome, hepatic dysfunction, end-stage renal failure (serum creatinine ≥117mmol/L), prior carotid endarterectomy, and/or patients who did not agree to participate in the present study.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01707615


Sponsors and Collaborators
Jie Qiu
National Natural Science Foundation of China
Investigators
Study Director: Jie Qiu, doctor Qilu Hospital of Shandong University
  More Information

Responsible Party: Jie Qiu, Qilu Hospital of Shandong University, Shandong University
ClinicalTrials.gov Identifier: NCT01707615     History of Changes
Other Study ID Numbers: 2010GGC10294
First Submitted: August 14, 2012
First Posted: October 16, 2012
Last Update Posted: October 16, 2012
Last Verified: October 2012

Keywords provided by Jie Qiu, Shandong University:
proanthocyanidin,atherosclerosis, carotid plaque

Additional relevant MeSH terms:
Atherosclerosis
Plaque, Atherosclerotic
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Proanthocyanidin
Procyanidin
Grape Seed Extract
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents