Effects of a Vitality Dietary Supplement on Physical and Mental Function in Middle-aged Adults
This study is ongoing, but not recruiting participants.
Sponsor:
Pharmanex
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Pharmanex
ClinicalTrials.gov Identifier:
NCT01155076
First received: June 29, 2010
Last updated: June 21, 2012
Last verified: July 2011
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Health-related Quality of Life |
Dietary Supplement: Vitality Product Dietary Supplement: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pharmanex:
Primary Outcome Measures:
- Health-related quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Medical Outcomes Study (MOS) Sexual Function questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 160 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vitality product
Proprietary blend of ginseng, cordyceps, and pomegranate
|
Dietary Supplement: Vitality Product
Proprietary blend of ginseng, cordyceps, and pomegranate taken twice a day for 8 weeks
|
|
Placebo Comparator: Placebo
Placebo
|
Dietary Supplement: Placebo
Placebo taken twice a day for 8 weeks
|
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155076
Locations
| United States, Arizona | |
| Quality of Life Medical and Research Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, Minnesota | |
| Ridgeview Chaska Medical Plaza | |
| Chaska, Minnesota, United States, 55318 | |
| United States, Texas | |
| West Houston Clinical Research Services | |
| Houston, Texas, United States, 77055 | |
Sponsors and Collaborators
Pharmanex
Sprim Advanced Life Sciences
Investigators
| Principal Investigator: | John McGettigan, MD | Quality of Life Medical & Research Center, LLC |
More Information
No publications provided
| Responsible Party: | Pharmanex |
| ClinicalTrials.gov Identifier: | NCT01155076 History of Changes |
| Other Study ID Numbers: | 10-SUS-03-NU-01 |
| Study First Received: | June 29, 2010 |
| Last Updated: | June 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 19, 2013