The Efficacy of Red Grape Seed Extract on Lipid Profile and Oxidized Low-Density Lipoprotein (OX-LDL)

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Antioxidants are potent scavengers of free radicals and serve as inhibitors of neoplastic processes. A large number of synthetic and natural antioxidants are known to induce beneficial effects on human health and disease prevention. Cardioprotective ability of grape seed extract polyphenols (GSEP) was studied in animals and humans. It has been suggested that grape seed proanthocyanidins have cardioprotective effects against reperfusion-induced injury of free radicals after ischemia. In another study, it is suggested that proanthocyanidins, the major polyphenols in red wine, might trap reactive oxygen species in aqueous series such as plasma and interstitial fluid of the arterial wall; thereby inhibiting oxidation of low-density lipoprotein (LDL) and showing an antiatherosclerotic activity. The only human model study designed to evaluate the effect of a standardized formulation of a GSEP (leucoselect-phytosome \[LP\]) on the susceptibility of LDL to oxidation in a group of heavy smokers, revealed that the antioxidant potential of GSEP may be effective in oxidative stress (smoking); however more investigational data are needed before wider use in clinical settings. Based on these observations, the investigators decided to evaluate the effect of GSEP in reducing OX-LDL in patients diagnosed with mild hyperlipidemia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Grape Seed Extract on Blood Pressure

NCT00869193

Elevated Blood Pressure

COMPLETED NA

Grape Polyphenols and Metabolic Syndrome

NCT04053569

Metabolic Syndrome, Protection Against

UNKNOWN NA

Grape Pomace Polyphenols and Cardiometabolic Risk

NCT03076463

Subjects at Cardiometabolic Risk

COMPLETED NA

Effect of a Grape Seed Proanthocyanidin Extract (GSPE) on LDL Cholesterol Levels in Rotating Night Shift Workers

NCT06422741

Cardiovascular Diseases Circadian Rhythm Sleep Disorder, Shift Work Type Cholesterol Level, High

RECRUITING NA

The Effect of Grape Seed Extract on Blood Pressure in People With Pre-Hypertension

NCT00979732

Hypertension

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperlipidemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Grape Seed Extract

Enrolled patients who are randomly assigned to receive Grape Seed Extract capsules

Group Type EXPERIMENTAL

Grape Seed Extract (Vitagrape)

Intervention Type DRUG

Drug {Each Containing: Grape Seed Extract100 mg +...}

1 capsule twice daily for 2 months

Placebo

Placebo enrolled patients who are randomly assigned to receive placebo of Grape Seed Extract

Group Type PLACEBO_COMPARATOR

Placebo of Grape Seed Extract

Intervention Type DRUG

Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg}

1 capsule twice daily for 2 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Grape Seed Extract (Vitagrape)

Drug {Each Containing: Grape Seed Extract100 mg +...}

1 capsule twice daily for 2 months

Intervention Type DRUG

Placebo of Grape Seed Extract

Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg}

1 capsule twice daily for 2 months

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vitagrape Iran Ministry of Health Registration Number: 5/92/43198

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Triglyceride \> 150 mg/dl
2. Total Cholesterol \> 200 mg/dl

Exclusion Criteria

1. Severe hyperlipidemia (Triglyceride \> 300 mg/dl,Total Cholesterol \> 250 mg/dl)
2. Usage of antilipid drugs
3. Herbivore Diet
4. Alcoholism
5. Heart failure
6. Known cases of any malignancy
7. BMI \> 30 kg/M2
8. Chronic Hepatic Diseases
9. Smoking
10. Chronic Renal Failure

Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.