Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Daniel Riche, University of Mississippi Medical Center

ClinicalTrials.gov Identifier:

NCT01267227

First received: December 17, 2010

Last updated: May 2, 2013

Last verified: May 2013

Results First Received: March 19, 2013

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

Baseline Characteristics

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]
<=18 years	0	0	0	0	0
Between 18 and 65 years	16	19	17	17	69
>=65 years	4	1	3	3	11

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)

Gender [Units: Participants]
Female	14	15	15	13	57
Male	6	5	5	7	23

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