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

NCT ID: NCT01707615

Last Updated: 2012-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2011-10-31

Brief Summary

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The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical use

Detailed Description

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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.

Conditions

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Atherosclerosis of Arteries of the Extremities, Unspecified

Keywords

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proanthocyanidin,atherosclerosis, carotid plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control group

In the control group, all patients were enrolled in a lifestyle intervention

Group Type OTHER

lifestyle intervention

Intervention Type OTHER

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

GSPE group

GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.

Group Type ACTIVE_COMPARATOR

GSPE

Intervention Type DRUG

GSPE 240 mg/day (120mg bid)

lifestyle intervention

Intervention Type OTHER

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

Interventions

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GSPE

GSPE 240 mg/day (120mg bid)

Intervention Type DRUG

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

Intervention Type OTHER

Other Intervention Names

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Grape seed proanthocyanidin extrat

Eligibility Criteria

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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.
Minimum Eligible Age

43 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Jie Qiu

OTHER

Sponsor Role lead

Responsible Party

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Jie Qiu

Qilu Hospital of Shandong University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jie Qiu, doctor

Role: STUDY_DIRECTOR

Qilu Hospital of Shandong University

Other Identifiers

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2010GGC10294

Identifier Type: -

Identifier Source: org_study_id