Status:
COMPLETED
Effect of OPC Factor on Energy Levels
Lead Sponsor:
University of Pennsylvania
Conditions:
Healthy
Eligibility:
All Genders
45-65 years
Phase:
PHASE2
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 recei...
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...
Eligibility Criteria
Inclusion
- 45 to 65 years of age at the time of recruitment
- Healthy -- see exclusion criteria
- 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
- Any major medical or mental illness (including a history of bipolar disorder, borderline personality disorder, and schizophrenia)
- 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
- Subjects taking the following medical therapies:
- Beta-blocking medications
- Human growth hormone
- Testosterone
- Warfarin
- Subjects taking the following complementary and alternative medicine (CAM) products:
- Feverfew
- Garlic supplements
- Ginseng
- Red clover
- 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
- 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.
- Subjects who are unable to make their own decisions regarding informed consent
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00318019
Start Date
June 1 2006
End Date
April 1 2008
Last Update
November 17 2011
Active Locations (1)
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1
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104