Effect of OPC Factor on Energy Levels

NCT ID: NCT00318019

Last Updated: 2011-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-04-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

OPC Factor(TM)

Group Type: EXPERIMENTAL

OPC Factor(TM)

Intervention Type: DIETARY_SUPPLEMENT

Evervescent poweder containing oligomeric proanthocyanidins (OPCs)and other nutrients.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Effervescent powder similar in taste and appearance to the intervention but without the OPCs and nutrients.

Interventions

OPC Factor(TM)

Evervescent poweder containing oligomeric proanthocyanidins (OPCs)and other nutrients.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Effervescent powder similar in taste and appearance to the intervention but without the OPCs and nutrients.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 45 to 65 years of age at the time of recruitment

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick J LaRiccia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

804315

Identifier Type: -

Identifier Source: org_study_id