Health-related Quality of LifeNCT01155076
Effects of a Vitality Dietary Supplement on Physical and Mental Function in Middle-aged Adults
A study testing Vitality Product in people with Health-related Quality of Life, run by Pharmanex at 3 sites in United States.
Trial summary
The purpose of the study is to determine the effects of 8 weeks Vitality Product supplementation on physical and mental function in middle-aged adults Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health-related Quality of Life
- What is being tested?
- Vitality Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2010to Nov 2013
- Phase
- Interventional
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 40-70 years
- Signed Informed Consent
- BMI between 19 and 30 kg/m2
- Normotensive, defined as systolic blood pressure 90-140 mmHg and diastolic blood pressure 50-90 mmHg
Who cannot join
- Regular dietary supplement use and unwilling to discontinue use at least 1 month prior to enrollment in the study
- Self-reported chronic condition that may affect subject safety (e.g. diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g. chronic fatigue)
- Pregnancy/suspected pregnancy, breastfeeding
- Antihypertensive medication use
- Allergies to any supplement ingredients
- Consumption of more than 600mg caffeine from any source per day
Show all 14Show fewer
- Consumption of "energy drinks" (e.g. Red Bull, Monster) or any herbal supplement known to affect energy levels
- Known iron anemia
- Medically treated for insomnia
- Medically treated for depression
- Taking medications known to affect energy, e.g. thyroid medication
- Tobacco user
- Planned surgical procedure in next 2 months
- Participating in another clinical (medical or nutritional) study or likely to enroll in another medical or nutritional study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ridgeview Chaska Medical Plaza
Chaska, Minnesota, 55318
West Houston Clinical Research Services
Houston, Texas, 77055
Quality of Life Medical and Research Center
Tucson, Arizona, 85712
About this study
Official title: Effects of a Proprietary Ginseng, Cordyceps, and Pomegranate Supplement on Physical and Mental Function in Middle-aged Adults: a Double-blind, Randomized, Placebo-controlled Trial
The purpose of the study is to determine the effects of 8 weeks Vitality Product supplementation on physical and mental function in middle-aged adults
- Conditions
- Health-related Quality of Life
- Being tested
- Vitality Product, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitality ProductDietary supplement
Proprietary blend of ginseng, cordyceps, and pomegranate taken twice a day for 8 weeks
PlaceboDietary supplement
Placebo taken twice a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitality product | Experimental | Proprietary blend of ginseng, cordyceps, and pomegranate Receives: Dietary Supplement: Vitality Product |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
Measured: 8 weeks
Secondary outcomes (2)
Medical Outcomes Study (MOS) Sexual Function questionnaire
Measured: 8 weeks
Adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health-related Quality of LifeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Responsible party
- Sponsor
- Investigators
- John McGettigan, MD, Principal investigator, Quality of Life Medical & Research Center, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155076
- Sponsor's protocol ID
- 10-SUS-03-NU-01
- Status last verified
- Nov 2013
- First submitted
- 29 Jun 2010
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Proprietary Ginseng, Cordyceps, and Pomegranate Supplement on Physical and Mental Function in Middle-aged Adults: a Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01155076
- Acronym / sponsor ID
- 10-SUS-03-NU-01
- Conditions
- Health-related Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- Jul 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 1 Jul 2010 (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.
The purpose of the study is to determine the effects of 8 weeks Vitality Product supplementation on physical and mental function in middle-aged adults
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitality product | Experimental | Dietary Supplement: Vitality ProductProprietary blend of ginseng, cordyceps, and pomegranate |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females aged 40-70 years
- Signed Informed Consent
- BMI between 19 and 30 kg/m2
- Normotensive, defined as systolic blood pressure 90-140 mmHg and diastolic blood pressure 50-90 mmHg
Key exclusion criteria (14 listed)
- Regular dietary supplement use and unwilling to discontinue use at least 1 month prior to enrollment in the study
- Self-reported chronic condition that may affect subject safety (e.g. diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g. chronic fatigue)
- Pregnancy/suspected pregnancy, breastfeeding
- Antihypertensive medication use
- Allergies to any supplement ingredients
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 |
|---|---|---|
| Vitality ProductProprietary blend of ginseng, cordyceps, and pomegranate taken twice a day for 8 weeks | Dietary supplement | Vitality product |
| PlaceboPlacebo taken twice a day for 8 weeks | Dietary supplement | Placebo |
Primary outcome
Health-related quality of life
Time frame: 8 weeks
2 secondary outcomes
Medical Outcomes Study (MOS) Sexual Function questionnaire
Time frame: 8 weeks
Adverse events
Time frame: 8 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 14 Nov 2013.
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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.
John McGettigan, MD principal investigator
Quality of Life Medical & Research Center, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitality Product in people with Health-related Quality of Life, run by Pharmanex at 3 sites 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 4 inclusion and 14 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 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Health-related quality of life (time frame: 8 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 14 Nov 2013.