Clinical trial NCT00318019: Effect of OPC Factor on Energy Levels
Official title: The Effect of OPC Factor on Energy Levels in Healthy Individuals Aged 45-65: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Energy
Energy Level
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2006-04-25
Enrollment: 27
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 45 to 65 years of age at the time of recruitment
2. Healthy -- see exclusion criteria
3. There is the possibility of at least a 20% absolute increase in the subject's energy subscale score of the Activation-Deactivation Adjective Checklist (AD ACL). For the purpose of meeting the inclusion criteria, the subject fills out the AD ACL with the following instructions: "Each of the words below describes feelings or moods. Please circle the rating next to each word that best describes your feelings during the past month. These instructions are different from the instructions used when the study endpoints are being measured so as to be consistent with the way the questionnaire was validated."

Exclusion Criteria:

1. Any major medical or mental illness (including a history of bipolar disorder, borderline personality disorder, and schizophrenia)
2. Medical diseases known to be associated with fatigue but not limited to:

   * AIDS
   * Anemia
   * Cancer or history of cancer (excluding basal cell carcinoma of the skin)
   * Chronic fatigue syndrome
   * Congestive heart failure
   * Chronic obstructive pulmonary disease (COPD)
   * Depression
   * Diabetes
   * Drug/alcohol dependence
   * Fibromyalgia
   * Hypertension that is uncontrolled or difficult to control
   * Hypothyroidism
3. Subjects taking the following medical therapies:

   * Beta-blocking medications
   * Human growth hormone
   * Testosterone
   * Warfarin
4. Subjects taking the following complementary and alternative medicine (CAM) products:

   * Feverfew
   * Garlic supplements
   * Ginseng
   * Red clover
5. Women who have not gone through menopause - those women who have had one or more menstrual periods in the 12 months prior to the enrollment in the study
6. The subject's score on the energy subscale of the AD ACL is at a level that precludes at least a 20% absolute increase of that score.
7. Subjects who are unable to make their own decisions regarding informed consent
8. Those subjects who have taken any of the medical therapies or CAM products listed but are no longer taking them are eligible to participate provided no other exclusion criteria are present and the subjects have not taken those therapies or products in the six months prior to enrollment.

Primary outcomes:
measure: Energy subscore on the Activation-Deactivation Adjective Check List
timeFrame: Nine weeks
Secondary outcomes:
measure: Four global change questions
timeFrame: Nine weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Patrick J LaRiccia, MD
role: PRINCIPAL_INVESTIGATOR
References: