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
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 healthy
Started Jun 2006
Typical duration for phase_2 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2006
CompletedFirst Posted
Study publicly available on registry
April 25, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedNovember 17, 2011
November 1, 2011
1.8 years
April 21, 2006
November 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Energy subscore on the Activation-Deactivation Adjective Check List
Nine weeks
Secondary Outcomes (1)
Four global change questions
Nine weeks
Study Arms (2)
OPC Factor(TM)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Evervescent poweder containing oligomeric proanthocyanidins (OPCs)and other nutrients.
Effervescent powder similar in taste and appearance to the intervention but without the OPCs and nutrients.
Eligibility Criteria
You may qualify if:
- to 65 years of age at the time of recruitment
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:
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick J LaRiccia, MD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2006
First Posted
April 25, 2006
Study Start
June 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
November 17, 2011
Record last verified: 2011-11