The effect of OPC Factor on energy levels in healthy adults ages 45-65: a phase IIb randomized controlled trial.
OBJECTIVE
To determine the efficacy of the food supplement OPC Factor to increase energy levels in healthy adults aged 45 to 65.


METHODS
Randomized, placebo-controlled, triple-blind crossover study.


METHODS
Twenty-five (25) healthy adults recruited from the University of Pennsylvania Health System.


METHODS
OPC Factor,trade mark (AlivenLabs, Lebanon, TN) a food supplement that contains oligomeric proanthocyanidins from grape seeds and pine bark along with other nutrient supplements including vitamins and minerals, was in the form of an effervescent powder. The placebo was similar in appearance and taste.


METHODS
Five outcome measurements were performed: (1) Energy subscale scores of the Activation-Deactivation Adjective Check List (AD ACL); (2) One (1) global question of percent energy change (Global Energy Percent Change); (3) One (1) global question of energy change measured on a Likert scale (Global Energy Scale Change); 4. One (1) global question of percent overall status change (Global Overall Status Percent Change); and (5) One (1) global question of overall status change measured on a Likert scale (Global Overall Status Scale Change).


RESULTS
There were no carryover/period effects in the groups randomized to Placebo/Active Product sequence versus Active Product/Placebo sequence. Examination of the AD ACL Energy subscale scores for the Active Product versus Placebo comparison revealed no significant difference in the intention-to-treat (IT) analysis and the treatment received (TR) analysis. However, Global Energy Percent Change (p = 0.06) and Global Energy Scale Change (p = 0.09) both closely approached conventional levels of statistical significance for the active product in the IT analysis. Global Energy Percent Change (p = 0.05) and Global Energy Scale Change (p = 0.04) reached statistical significance in the TR analysis. A cumulative percent responders analysis graph indicated greater response rates for the active product.


CONCLUSIONS
OPC Factor may increase energy levels in healthy adults aged 45-65 years. A larger study is recommended. Clinical Trials.gov identifier: NCT03318019.
LaRiccia
Patrick J
PJ
Penn-Presbyterian Medical Center, Philadelphia, PA, USA. lariccip@mail.med.upenn.edu
Farrar
John T
JT
Sammel
Mary D
MD
Gallo
Joseph J
JJ
D000368:Aged; D018592:Cross-Over Studies; D004734:Energy Metabolism / Q000502:physiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008903:Minerals / Q000627:therapeutic use; D008517:Phytotherapy / Q000379:methods*; D028223:Pinus; D024301:Plant Bark; D028321:Plant Preparations / Q000627:therapeutic use; D012639:Seeds; D027843:Vitis
D008903:Minerals; C533972:OPC factor; D028321:Plant Preparations