Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

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ClinicalTrials.gov Identifier: NCT01267227

Recruitment Status : Completed

First Posted : December 28, 2010

Results First Posted : May 3, 2013

Last Update Posted : January 10, 2018

Sponsor:

Information provided by (Responsible Party):

Daniel Riche, University of Mississippi Medical Center

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Hyperlipidemia Blood Pressure Oxidative Stress
Interventions:	Drug: Pterostilbene 50 mg twice daily Drug: Placebo Drug: Grape Extract Drug: Pterostilbene 125 mg twice daily

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Medical clinic

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
High Dose	Pterostilbene 125 mg twice daily
Low Dose	Pterostilbene 50 mg twice daily
Low Dose Combination	Pterostilbene 50 mg/Grape Extract 100 mg twice daily
Placebo	Matching placebo twice daily

Participant Flow: Overall Study

	High Dose	Low Dose	Low Dose Combination	Placebo
STARTED	20	20	20	20
COMPLETED	19	19	18	17
NOT COMPLETED	1	1	2	3

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
High Dose	Pterostilbene 125 mg twice daily
Low Dose	Pterostilbene 50 mg twice daily
Low Dose Combination	Pterostilbene 50 mg/Grape Extract 100 mg twice daily
Placebo	Matching placebo twice daily
Total	Total of all reporting groups

Baseline Measures

	High Dose	Low Dose	Low Dose Combination	Placebo	Total
Overall Participants Analyzed [Units: Participants]	20	20	20	20	80

Age [Units: Participants] Count of Participants
<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Between 18 and 65 years	16 80.0%	19 95.0%	17 85.0%	17 85.0%	69 86.3%
>=65 years	4 20.0%	1 5.0%	3 15.0%	3 15.0%	11 13.8%

Age [Units: Years] Mean (Standard Deviation)	53.6 (11.2)	53.6 (7.9)	53.0 (13.7)	54.4 (11.9)	53.6 (11.2)

Sex: Female, Male [Units: Participants] Count of Participants
Female	14 70.0%	15 75.0%	15 75.0%	13 65.0%	57 71.3%
Male	6 30.0%	5 25.0%	5 25.0%	7 35.0%	23 28.7%

Region of Enrollment [Units: Participants]
United States	20	20	20	20	80

Outcome Measures

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1. Primary:

LDL [ Time Frame: Baseline and 6-8 weeks ]

Measure Type	Primary
Measure Title	LDL
Measure Description	Increase in low density lipoprotein (LDL)
Time Frame	Baseline and 6-8 weeks

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
High Dose	Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
Low Dose	Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
Low Dose Combination	Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
Placebo	Matching placebo twice daily. Unadjusted change from baseline.

Measured Values

	High Dose	Low Dose	Low Dose Combination	Placebo
Participants Analyzed [Units: Participants]	20	20	20	20
LDL [Units: mg/dL] Mean (95% Confidence Interval)	19.67 (5.28 to 34.05)	20.04 (5.68 to 34.40)	5.33 (-9.16 to 19.82)	0 (0 to 0)

No statistical analysis provided for LDL

2. Secondary:

Blood Pressure [ Time Frame: 6-8 weeks ]

Measure Type	Secondary
Measure Title	Blood Pressure
Measure Description	Reduction in systolic blood pressure versus placebo
Time Frame	6-8 weeks

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
High Dose	Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
Low Dose	Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
Low Dose Combination	Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
Placebo	Matching placebo twice daily. Unadjusted change from baseline.

Measured Values

	High Dose	Low Dose	Low Dose Combination	Placebo
Participants Analyzed [Units: Participants]	20	20	20	20
Blood Pressure [Units: mmHg] Mean (95% Confidence Interval)	7.77 (2.38 to 13.17)	3.67 (-1.74 to 9.09)	6.72 (1.25 to 12.18)	0 (0 to 0)

No statistical analysis provided for Blood Pressure

3. Secondary:

Subjective Adverse Effects [ Time Frame: Baseline and 6-8 weeks ]

Measure Type	Secondary
Measure Title	Subjective Adverse Effects
Measure Description	Number of participants with adverse effects as a measure of safety
Time Frame	Baseline and 6-8 weeks

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
High Dose	Pterostilbene 125 mg twice daily
Low Dose	Pterostilbene 50 mg twice daily
Low Dose Combination	Pterostilbene 50 mg/Grape Extract 100 mg twice daily
Placebo	Matching placebo twice daily

Measured Values

	High Dose	Low Dose	Low Dose Combination	Placebo
Participants Analyzed [Units: Participants]	20	20	20	20
Subjective Adverse Effects [Units: Participants]	5	3	2	2

No statistical analysis provided for Subjective Adverse Effects

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Disclosure of the submitted materials approved per contractual agreement.

Results Point of Contact:

Name/Title: Dr. Daniel Riche
Organization: University of Mississippi
phone: 601-984-2640
e-mail: driche@umc.edu

Publications of Results:

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.

Riche 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.

Other 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.

Rimando 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.

Rimando 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.

Amarnath 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.

Satheesh 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.

Responsible Party:	Daniel Riche, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:	NCT01267227 History of Changes
Other Study ID Numbers:	2010-0225
First Submitted:	December 17, 2010
First Posted:	December 28, 2010
Results First Submitted:	March 19, 2013
Results First Posted:	May 3, 2013
Last Update Posted:	January 10, 2018

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