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

This study has been completed.
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Jie Qiu, Shandong University
ClinicalTrials.gov Identifier:
NCT01707615
First received: August 14, 2012
Last updated: October 14, 2012
Last verified: October 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   43 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT01707615

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

No publications provided

Responsible Party: Jie Qiu, Qilu Hospital of Shandong University, Shandong University
ClinicalTrials.gov Identifier: NCT01707615     History of Changes
Other Study ID Numbers: 2010GGC10294
Study First Received: August 14, 2012
Last Updated: October 14, 2012
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 28, 2014