Effects of a Vitality Dietary Supplement on Physical and Mental Function in Middle-aged Adults
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
1 other identifier
interventional
116
1 country
3
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2010
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2010
CompletedFirst Posted
Study publicly available on registry
July 1, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 14, 2013
November 1, 2013
2.3 years
June 29, 2010
November 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Health-related quality of life
8 weeks
Secondary Outcomes (2)
Medical Outcomes Study (MOS) Sexual Function questionnaire
8 weeks
Adverse events
8 weeks
Study Arms (2)
Vitality product
EXPERIMENTALProprietary blend of ginseng, cordyceps, and pomegranate
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Proprietary blend of ginseng, cordyceps, and pomegranate taken twice a day for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmanexlead
- Sprim Advanced Life Sciencescollaborator
Study Sites (3)
Quality of Life Medical and Research Center
Tucson, Arizona, 85712, United States
Ridgeview Chaska Medical Plaza
Chaska, Minnesota, 55318, United States
West Houston Clinical Research Services
Houston, Texas, 77055, United States
Study Officials
- PRINCIPAL INVESTIGATOR
John McGettigan, MD
Quality of Life Medical & Research Center, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2010
First Posted
July 1, 2010
Study Start
July 1, 2010
Primary Completion
November 1, 2012
Study Completion
November 1, 2013
Last Updated
November 14, 2013
Record last verified: 2013-11