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HyperlipidemiaPhase 2/3GSENCT00713167

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

A Phase 2/3 study testing Grape Seed Extract (Vitagrape) in people with Hyperlipidemia, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 64 years
Conditions the study is for
Hyperlipidemia
What is being tested?
Grape Seed Extract (Vitagrape)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
2 sitesIran
Study dates
Jul 2008to Feb 2009
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Triglyceride > 150 mg/dl
  • Total Cholesterol > 200 mg/dl

Who cannot join

  • Severe hyperlipidemia (Triglyceride > 300 mg/dl,Total Cholesterol > 250 mg/dl)
  • Usage of antilipid drugs
  • Herbivore Diet
  • Alcoholism
  • Heart failure
  • Known cases of any malignancy
Show all 10Show fewer
  • BMI > 30 kg/M2
  • Chronic Hepatic Diseases
  • Smoking
  • Chronic Renal Failure

Trial locations and contacts

2 sites in 1 country.

Iran2 sites

  • Ghorbanihaghjo

    Tabriz, East Azarbayejan

  • Maryam

    Tehran, Tehran Province, 19814

Other trials in Iran

About this study

Official title: Randomized, Cross-Over, Double Blind, Placebo-Controlled Study of Grape Seed Extract in Treating Patients With Mild Hyperlipidemia

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.

Conditions
Hyperlipidemia
Being tested
Grape Seed Extract (Vitagrape), Placebo of Grape Seed Extract
Keywords
Grape Seed Extract, Hyperlipidemia
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Grape Seed Extract (Vitagrape)Drug

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

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

    1 capsule twice daily for 2 months

  • Placebo of Grape Seed ExtractDrug

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

    1 capsule twice daily for 2 months

Study groups in NCT00713167
Study groupRoleWhat they receive
Grape Seed ExtractExperimentalEnrolled patients who are randomly assigned to receive Grape Seed Extract capsules
Receives: Drug: Grape Seed Extract (Vitagrape)
PlaceboPlacebo comparatorPlacebo enrolled patients who are randomly assigned to receive placebo of Grape Seed Extract
Receives: Drug: Placebo of Grape Seed Extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OX-LDL

    Measured: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

Secondary outcomes (7)

  1. LDL

    Measured: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

  2. HDL

    Measured: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

  3. Blood Pressure

    Measured: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

  4. Triglyceride

    Measured: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

  5. Total Cholesterol

    Measured: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

  6. Body Mass Index

    Measured: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed

  7. LDL/HDL

    Measured: 8 weeks- {45 days wash out, crossed }- 8 weeks after crossed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionDec 2008
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00713167
Sponsor's protocol ID
SBMU 87-01-106-5694
Acronym
GSE
Status last verified
May 2009
First submitted
8 Jul 2008
Last updated
21 May 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Bagchi D, Bagchi M, Stohs SJ, Das DK, Ray SD, Kuszynski CA, Joshi SS, Pruess HG. Free radicals and grape seed proanthocyanidin extract: importance in human health and disease prevention. Toxicology. 2000 Aug 7;148(2-3):187-97. doi: 10.1016/s0300-483x(00)00210-9.

    PubMed 10962138

  • Bagchi D, Sen CK, Ray SD, Das DK, Bagchi M, Preuss HG, Vinson JA. Molecular mechanisms of cardioprotection by a novel grape seed proanthocyanidin extract. Mutat Res. 2003 Feb-Mar;523-524:87-97. doi: 10.1016/s0027-5107(02)00324-x.

    PubMed 12628506

  • Pataki T, Bak I, Kovacs P, Bagchi D, Das DK, Tosaki A. Grape seed proanthocyanidins improved cardiac recovery during reperfusion after ischemia in isolated rat hearts. Am J Clin Nutr. 2002 May;75(5):894-9. doi: 10.1093/ajcn/75.5.894.

    PubMed 11976164

  • Joshi SS, Kuszynski CA, Bagchi D. The cellular and molecular basis of health benefits of grape seed proanthocyanidin extract. Curr Pharm Biotechnol. 2001 Jun;2(2):187-200. doi: 10.2174/1389201013378725.

    PubMed 11480422

  • Bagchi D, Garg A, Krohn RL, Bagchi M, Bagchi DJ, Balmoori J, Stohs SJ. Protective effects of grape seed proanthocyanidins and selected antioxidants against TPA-induced hepatic and brain lipid peroxidation and DNA fragmentation, and peritoneal macrophage activation in mice. Gen Pharmacol. 1998 May;30(5):771-6. doi: 10.1016/s0306-3623(97)00332-7.

    PubMed 9559333

  • Yamakoshi J, Kataoka S, Koga T, Ariga T. Proanthocyanidin-rich extract from grape seeds attenuates the development of aortic atherosclerosis in cholesterol-fed rabbits. Atherosclerosis. 1999 Jan;142(1):139-49. doi: 10.1016/s0021-9150(98)00230-5.

    PubMed 9920515

  • Zhang FL, Gao HQ, Wu JM, Ma YB, You BA, Li BY, Xuan JH. Selective inhibition by grape seed proanthocyanidin extracts of cell adhesion molecule expression induced by advanced glycation end products in endothelial cells. J Cardiovasc Pharmacol. 2006 Aug;48(2):47-53. doi: 10.1097/01.fjc.0000242058.72471.0c.

    PubMed 16954821

  • Vigna GB, Costantini F, Aldini G, Carini M, Catapano A, Schena F, Tangerini A, Zanca R, Bombardelli E, Morazzoni P, Mezzetti A, Fellin R, Maffei Facino R. Effect of a standardized grape seed extract on low-density lipoprotein susceptibility to oxidation in heavy smokers. Metabolism. 2003 Oct;52(10):1250-7. doi: 10.1016/s0026-0495(03)00192-6.

    PubMed 14564675

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Grape Seed Extract (Vitagrape) in people with Hyperlipidemia, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OX-LDL (time frame: 8 weeks -{45 days wash out, crossed }- 8 weeks after crossed). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00713167, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2009.

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