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

NCT01707615 | Completed Phase 2 DMC

• 1 other identifier: 2010GGC10294
• Study Type: interventional
• Target: 287
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Atherosclerosis of Arteries of the Extremities, Unspecified

Keywords

proanthocyanidin,atherosclerosis, carotid plaque

Outcome Measures

Primary Outcomes (1)

• Carotid B-Mode Ultrasound

  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.

  Carotid ultrasound examination was performed at baseline and 6, 12, 24months after treatment.The change of carotid plaque was record within 24 months.

Secondary Outcomes (1)

• clinical vascular events

  after 24 months follow-up

Study Arms (2)

control group

OTHER

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

Other: lifestyle intervention

GSPE group

ACTIVE COMPARATOR

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

Drug: GSPE; Other: lifestyle intervention

Interventions

GSPE DRUG

GSPE 240 mg/day (120mg bid)

Also known as: Grape seed proanthocyanidin extrat

GSPE group

lifestyle intervention 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; control group

Eligibility Criteria

• Age: 43 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jie Qiu: lead
• National Natural Science Foundation of China: collaborator

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jie Qiu, doctor

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Qilu Hospital of Shandong University

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: October 16, 2012
• Study Start: October 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 16, 2012

Record last verified: 2012-10