- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00318019
Effect of OPC Factor on Energy Levels
The Effect of OPC Factor on Energy Levels in Healthy Individuals Aged 45-65: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Penn Presbyterian Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Effervescent powder similar in taste and appearance to the intervention but without the OPCs and nutrients.
|
EXPERIMENTAL: OPC Factor(TM)
|
Evervescent poweder containing oligomeric proanthocyanidins (OPCs)and other nutrients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Energy subscore on the Activation-Deactivation Adjective Check List
Time Frame: Nine weeks
|
Nine weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Four global change questions
Time Frame: Nine weeks
|
Nine weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick J LaRiccia, MD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 804315
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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