Status:
COMPLETED
Effects of a Vitality Dietary Supplement on Physical and Mental Function in Middle-aged Adults
Lead Sponsor:
Pharmanex
Collaborating Sponsors:
Sprim Advanced Life Sciences
Conditions:
Health-related Quality of Life
Eligibility:
All Genders
40-70 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT01155076
Start Date
July 1 2010
End Date
November 1 2013
Last Update
November 14 2013
Active Locations (3)
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1
Quality of Life Medical and Research Center
Tucson, Arizona, United States, 85712
2
Ridgeview Chaska Medical Plaza
Chaska, Minnesota, United States, 55318
3
West Houston Clinical Research Services
Houston, Texas, United States, 77055