Effect of OPC Factor on Energy Levels

Completed · Phase 2 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00318019

Run by

University of Pennsylvania

People needed

27

Starts

2006-06-01

Expected to finish

2008-04-01

Last updated by the study team

2011-11-17

Who can join

Age: 45 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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."

You may not qualify if…

• 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

Where it is running

• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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