HealthyPhase 2NCT00318019
Effect of OPC Factor on Energy Levels
A Phase 2 study testing OPC Factor(TM) in people with Healthy, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- OPC Factor(TM)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Apr 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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."
Who cannot join
- 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
Show all 28Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Effect of OPC Factor on Energy Levels in Healthy Individuals Aged 45-65: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- OPC Factor(TM), Placebo
- Keywords
- Energy, Energy Level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC Factor(TM)Dietary supplement
Evervescent poweder containing oligomeric proanthocyanidins (OPCs)and other nutrients.
PlaceboOther
Effervescent powder similar in taste and appearance to the intervention but without the OPCs and nutrients.
| Study group | Role | What they receive |
|---|---|---|
| OPC Factor(TM) | Experimental | Not described Receives: Dietary Supplement: OPC Factor(TM) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy subscore on the Activation-Deactivation Adjective Check List
Measured: Nine weeks
Secondary outcomes (1)
Four global change questions
Measured: Nine weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startJun 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick J LaRiccia, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318019
- Sponsor's protocol ID
- 804315
- Status last verified
- Nov 2011
- First submitted
- 21 Apr 2006
- Last updated
- 17 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of OPC Factor on Energy Levels in Healthy Individuals Aged 45-65: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00318019
- Acronym / sponsor ID
- 804315
- Conditions
- Healthy
- Keywords
- Energy, Energy Level
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 25 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPC Factor(TM) | Experimental | Dietary Supplement: OPC Factor(TM) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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."
Key exclusion criteria (28 listed)
- 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:
- Subjects taking the following medical therapies:
- Subjects taking the following complementary and alternative medicine (CAM) products:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPC Factor(TM)Evervescent poweder containing oligomeric proanthocyanidins (OPCs)and other nutrients. | Dietary supplement | OPC Factor(TM) |
| PlaceboEffervescent powder similar in taste and appearance to the intervention but without the OPCs and nutrients. | Other | Placebo |
Primary outcome
Energy subscore on the Activation-Deactivation Adjective Check List
Time frame: Nine weeks
1 secondary outcome
Four global change questions
Time frame: Nine weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J LaRiccia, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OPC Factor(TM) in people with Healthy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy subscore on the Activation-Deactivation Adjective Check List (time frame: Nine weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2011.