Effect of OPC Factor on Energy Levels
In this study the food supplement OPC Factor will be tested to determine its effectiveness for increasing energy levels in healthy people aged 45-65 when compared to a placebo. All subjects will receive both active product and placebo at some time during the study. The study is nine weeks in duration. It involves three visits, taking an effervescent powder in water twice a day, and answering 24 multiple choice questions once a week. Subjects who complete the study can elect to receive a two month supply of the study product free of charge.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of OPC Factor on Energy Levels in Healthy Individuals Aged 45-65: A Randomized Controlled Trial|
- Energy subscore on the Activation-Deactivation Adjective Check List [ Time Frame: Nine weeks ] [ Designated as safety issue: No ]
- Four global change questions [ Time Frame: Nine weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
|Experimental: OPC Factor(TM)||
Dietary Supplement: OPC Factor(TM)
Evervescent poweder containing oligomeric proanthocyanidins (OPCs)and other nutrients.
|Placebo Comparator: Placebo||
Effervescent powder similar in taste and appearance to the intervention but without the OPCs and nutrients.
OPC Factor, a food supplement which contains grape seed extract, pine bark extract,vitamins and minerals, has shown during clinical observation the effect of raising energy levels in people aged 45-65. It is believed that the mechanism of action is based on enhanced production of ATP by mitochondria.
In this study subjects will be assigned by chance to either the active product group or the placebo group. Subjects will take the product for three weeks. Then there will be a two week wash out period followed by subjects being crossed over to the other group for a three week period. Subjects, assessors, and health providers will be masked as to who is in the active product group and who is in the placebo group. Subjects will meet with the primary investigator three times during the study, will fill out very short questions once a week, and receive phone calls once a week from study personnel.
This study is a randomized, placebo controlled, triple-blinded, cross-over study that tests the hypothesis that OPC Factor produces a response rate of 70% in the active product phase versus a 30% response rate during the placebo phase. A response is defined as at least a 20% absolute increase on the Energy subscale of the Activation-Deactivation Adjective Check List.
|United States, Pennsylvania|
|Penn Presbyterian Medical Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Patrick J LaRiccia, MD||University of Pennsylvania|