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Effect of OPC Factor on Energy Levels

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00318019
First received: April 21, 2006
Last updated: November 16, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Dietary Supplement: OPC Factor(TM)
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of OPC Factor on Energy Levels in Healthy Individuals Aged 45-65: A Randomized Controlled Trial

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Energy subscore on the Activation-Deactivation Adjective Check List [ Time Frame: Nine weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Four global change questions [ Time Frame: Nine weeks ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: June 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPC Factor(TM) Dietary Supplement: OPC Factor(TM)
Evervescent poweder containing oligomeric proanthocyanidins (OPCs)and other nutrients.
Placebo Comparator: Placebo Other: Placebo
Effervescent powder similar in taste and appearance to the intervention but without the OPCs and nutrients.

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

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318019

Locations
United States, Pennsylvania
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Patrick J LaRiccia, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00318019     History of Changes
Other Study ID Numbers: 804315
Study First Received: April 21, 2006
Last Updated: November 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Energy
Energy Level

ClinicalTrials.gov processed this record on June 17, 2013