HyperlipidemiaPhase 2/3NCT01267227
Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
A Phase 2/3 study testing Pterostilbene 50 mg twice daily, Grape Extract and Pterostilbene 125 mg twice daily in people with Hyperlipidemia and Blood Pressure, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
Pterostilbene is one of several stilbenes found in certain berries, particularly blueberries, that have demonstrated pre-clinical benefit to cholesterol, blood pressure, and oxidative stress. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Hyperlipidemia, Blood Pressure, Oxidative Stress
- What is being tested?
- Pterostilbene 50 mg twice daily, Grape Extract and Pterostilbene 125 mg twice daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Feb 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years of age with a previous TC ≥200 mg/dL and/or a LDL ≥100 mg/dL on either no therapy or stable therapy
- Any concomitant cholesterol medication (not listed in the exclusion criteria) must be at a stable dose for at least 2 months prior to baseline laboratory
Who cannot join
- Patients with significant hepatic, renal or gastrointestinal tract disease
- Receiving thiazolidinediones or fibric acid derivatives
- Current overt cardiovascular disease
- Women of reproductive potential not receiving birth control
- Pregnant/nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Pterostilbene is one of several stilbenes found in certain berries, particularly blueberries, that have demonstrated pre-clinical benefit to cholesterol, blood pressure, and oxidative stress. The purpose of this study is to evaluate whether pterostilbene will help control cholesterol and blood pressure, as well as improve markers for oxidative stress in patients with dyslipidemia meeting inclusion criteria. The investigators also want to look at the safety of pterostilbene in these patients.
Read the detailed description
Subjects will be divided into one of four groups: (1) pterostilbene 50 mg twice daily; (2) pterostilbene 125 mg twice daily; (3) pterostilbene 50 mg/grape extract 100 mg twice daily; (4) matching placebo twice daily taken either one hour before or two hours after a meal. Blood and urine will be collected at enrollment and final study visits. If the patient's low density lipoprotein-C (LDL-C) or total cholesterol (TC) is not within the inclusion criteria based on enrollment blood drawn, the patient will not be allowed to initiate study medication. All study visits will consist of brief clinical examination (including vital signs), subjective adverse event reporting, and fasting donated blood and urine for clinical laboratory tests. Pill counts will be done to assess compliance.
- Conditions
- Hyperlipidemia, Blood Pressure, Oxidative Stress
- Being tested
- Pterostilbene 50 mg twice daily, Placebo, Grape Extract, Pterostilbene 125 mg twice daily
- Keywords
- Hyperlipidemia, Cholesterol, Blood Pressure, Oxidative Stress, Pterostilbene, Blueberry, Grape Extract
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pterostilbene 50 mg twice dailyDrug
Also called pTeroPure
Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks
PlaceboDrug
Matching placebo by mouth twice daily for 6 to 8 weeks
Grape ExtractDrug
Also called ShanStar Concord Grape
Grape extract 100 mg twice daily for 6-8 weeks
Pterostilbene 125 mg twice dailyDrug
Also called pTeropure
Pterostilbene 125 mg twice daily for 6-8 weeks
| Study group | Role | What they receive |
|---|---|---|
| High Dose | Active comparator | Pterostilbene 125 mg twice daily Receives: Drug: Pterostilbene 125 mg twice daily |
| Low Dose | Active comparator | Pterostilbene 50 mg twice daily Receives: Drug: Pterostilbene 50 mg twice daily |
| Low Dose Combination | Active comparator | Pterostilbene 50 mg/Grape Extract 100 mg twice daily Receives: Drug: Pterostilbene 50 mg twice daily; Drug: Grape Extract |
| Placebo | Placebo comparator | Matching placebo twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL
Increase in low density lipoprotein (LDL)
Measured: Baseline and 6-8 weeks
Secondary outcomes (2)
Blood Pressure
Reduction in systolic blood pressure versus placebo
Measured: 6-8 weeks
Subjective Adverse Effects
Number of participants with adverse effects as a measure of safety
Measured: Baseline and 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Riche, University of Mississippi Medical Center
- Investigators
- Daniel M Riche, Pharm.D., Principal investigator, University of Mississsippi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267227
- Sponsor's protocol ID
- 2010-0225
- Status last verified
- Dec 2017
- First submitted
- 17 Dec 2010
- Last updated
- 10 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Paul S, Rimando AM, Lee HJ, Ji Y, Reddy BS, Suh N. Anti-inflammatory action of pterostilbene is mediated through the p38 mitogen-activated protein kinase pathway in colon cancer cells. Cancer Prev Res (Phila). 2009 Jul;2(7):650-7. doi: 10.1158/1940-6207.CAPR-08-0224. Epub 2009 Jun 23.
PubMed 19549798Rimando AM, Kalt W, Magee JB, Dewey J, Ballington JR. Resveratrol, pterostilbene, and piceatannol in vaccinium berries. J Agric Food Chem. 2004 Jul 28;52(15):4713-9. doi: 10.1021/jf040095e.
PubMed 15264904Rimando AM, Nagmani R, Feller DR, Yokoyama W. Pterostilbene, a new agonist for the peroxisome proliferator-activated receptor alpha-isoform, lowers plasma lipoproteins and cholesterol in hypercholesterolemic hamsters. J Agric Food Chem. 2005 May 4;53(9):3403-7. doi: 10.1021/jf0580364.
PubMed 15853379Amarnath Satheesh M, Pari L. The antioxidant role of pterostilbene in streptozotocin-nicotinamide-induced type 2 diabetes mellitus in Wistar rats. J Pharm Pharmacol. 2006 Nov;58(11):1483-90. doi: 10.1211/jpp.58.11.0009.
PubMed 17132211Satheesh AM, Pari L. Effect of pterostilbene on lipids and lipid profiles in streptozotocin-nicotinamide induced type 2 diabetes mellitus. Journal of Applied Biomedine 6(1):31-37, 2008.
Riche DM, Riche KD, Blackshear CT, McEwen CL, Sherman JJ, Wofford MR, Griswold ME. Pterostilbene on metabolic parameters: a randomized, double-blind, and placebo-controlled trial. Evid Based Complement Alternat Med. 2014;2014:459165. doi: 10.1155/2014/459165. Epub 2014 Jun 25.
PubMed 25057276Riche DM, McEwen CL, Riche KD, Sherman JJ, Wofford MR, Deschamp D, Griswold M. Analysis of safety from a human clinical trial with pterostilbene. J Toxicol. 2013;2013:463595. doi: 10.1155/2013/463595. Epub 2013 Feb 4.
PubMed 23431291
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
- ClinicalTrials.gov ID
- NCT01267227
- Acronym / sponsor ID
- 2010-0225
- Conditions
- Hyperlipidemia, Blood Pressure, Oxidative Stress
- Keywords
- Hyperlipidemia, Cholesterol, Blood Pressure, Oxidative Stress, Pterostilbene, Blueberry, Grape Extract
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 28 Dec 2010 (estimated)
- Results
- Posted 3 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pterostilbene is one of several stilbenes found in certain berries, particularly blueberries, that have demonstrated pre-clinical benefit to cholesterol, blood pressure, and oxidative stress. The purpose of this study is to evaluate whether pterostilbene will help control cholesterol and blood pressure, as well as improve markers for oxidative stress in patients with dyslipidemia meeting inclusion criteria. The investigators also want to look at the safety of pterostilbene in these patients.
Detailed description
Subjects will be divided into one of four groups: (1) pterostilbene 50 mg twice daily; (2) pterostilbene 125 mg twice daily; (3) pterostilbene 50 mg/grape extract 100 mg twice daily; (4) matching placebo twice daily taken either one hour before or two hours after a meal. Blood and urine will be collected at enrollment and final study visits. If the patient's low density lipoprotein-C (LDL-C) or total cholesterol (TC) is not within the inclusion criteria based on enrollment blood drawn, the patient will not be allowed to initiate study medication. All study visits will consist of brief clinical examination (including vital signs), subjective adverse event reporting, and fasting donated blood and urine for clinical laboratory tests. Pill counts will be done to assess compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Dose | Active comparator | Drug: Pterostilbene 125 mg twice dailyPterostilbene 125 mg twice daily |
| Low Dose | Active comparator | Drug: Pterostilbene 50 mg twice dailyPterostilbene 50 mg twice daily |
| Low Dose Combination | Active comparator | Drug: Pterostilbene 50 mg twice daily, Drug: Grape ExtractPterostilbene 50 mg/Grape Extract 100 mg twice daily |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo twice daily |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥18 years of age with a previous TC ≥200 mg/dL and/or a LDL ≥100 mg/dL on either no therapy or stable therapy
- Any concomitant cholesterol medication (not listed in the exclusion criteria) must be at a stable dose for at least 2 months prior to baseline laboratory
Key exclusion criteria (5 listed)
- Patients with significant hepatic, renal or gastrointestinal tract disease
- Receiving thiazolidinediones or fibric acid derivatives
- Current overt cardiovascular disease
- Women of reproductive potential not receiving birth control
- Pregnant/nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pterostilbene 50 mg twice dailyAlso: pTeroPurePterostilbene 50 mg twice by mouth daily for 6 to 8 weeks | Drug | Low Dose, Low Dose Combination |
| PlaceboMatching placebo by mouth twice daily for 6 to 8 weeks | Drug | Placebo |
| Grape ExtractAlso: ShanStar Concord GrapeGrape extract 100 mg twice daily for 6-8 weeks | Drug | Low Dose Combination |
| Pterostilbene 125 mg twice dailyAlso: pTeropurePterostilbene 125 mg twice daily for 6-8 weeks | Drug | High Dose |
Primary outcome
LDL
Time frame: Baseline and 6-8 weeks
Increase in low density lipoprotein (LDL)
2 secondary outcomes
Blood Pressure
Time frame: 6-8 weeks
Subjective Adverse Effects
Time frame: Baseline and 6-8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19549798Paul S, Rimando AM, Lee HJ, Ji Y, Reddy BS, Suh N. Anti-inflammatory action of pterostilbene is mediated through the p38 mitogen-activated protein kinase pathway in colon cancer cells. Cancer Prev Res (Phila). 2009 Jul;2(7):650-7. doi: 10.1158/1940-6207.CAPR-08-0224. Epub 2009 Jun 23.
- Background: PubMed 15264904Rimando AM, Kalt W, Magee JB, Dewey J, Ballington JR. Resveratrol, pterostilbene, and piceatannol in vaccinium berries. J Agric Food Chem. 2004 Jul 28;52(15):4713-9. doi: 10.1021/jf040095e.
- Background: PubMed 15853379Rimando AM, Nagmani R, Feller DR, Yokoyama W. Pterostilbene, a new agonist for the peroxisome proliferator-activated receptor alpha-isoform, lowers plasma lipoproteins and cholesterol in hypercholesterolemic hamsters. J Agric Food Chem. 2005 May 4;53(9):3403-7. doi: 10.1021/jf0580364.
- Background: PubMed 17132211Amarnath Satheesh M, Pari L. The antioxidant role of pterostilbene in streptozotocin-nicotinamide-induced type 2 diabetes mellitus in Wistar rats. J Pharm Pharmacol. 2006 Nov;58(11):1483-90. doi: 10.1211/jpp.58.11.0009.
- BackgroundSatheesh AM, Pari L. Effect of pterostilbene on lipids and lipid profiles in streptozotocin-nicotinamide induced type 2 diabetes mellitus. Journal of Applied Biomedine 6(1):31-37, 2008.
- Results publication: PubMed 25057276Riche DM, Riche KD, Blackshear CT, McEwen CL, Sherman JJ, Wofford MR, Griswold ME. Pterostilbene on metabolic parameters: a randomized, double-blind, and placebo-controlled trial. Evid Based Complement Alternat Med. 2014;2014:459165. doi: 10.1155/2014/459165. Epub 2014 Jun 25.
- Results publication: PubMed 23431291Riche DM, McEwen CL, Riche KD, Sherman JJ, Wofford MR, Deschamp D, Griswold M. Analysis of safety from a human clinical trial with pterostilbene. J Toxicol. 2013;2013:463595. doi: 10.1155/2013/463595. Epub 2013 Feb 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel M Riche, Pharm.D. principal investigator
University of Mississsippi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pterostilbene 50 mg twice daily, Grape Extract and Pterostilbene 125 mg twice daily in people with Hyperlipidemia and Blood Pressure, run by University of Mississippi Medical Center at 1 site in United States.
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 5 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 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 3 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
LDL (time frame: Baseline and 6-8 weeks). 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 NCT01267227, which also lists 7 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 10 Jan 2018.