Effects of a Vitality Dietary Supplement on Physical and Mental Function in Middle-aged Adults

This study has been completed.
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Pharmanex
ClinicalTrials.gov Identifier:
NCT01155076
First received: June 29, 2010
Last updated: November 12, 2013
Last verified: November 2013

June 29, 2010
November 12, 2013
July 2010
November 2012   (final data collection date for primary outcome measure)
Health-related quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01155076 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Health-related Quality of Life
  • Dietary Supplement: Vitality Product
    Proprietary blend of ginseng, cordyceps, and pomegranate taken twice a day for 8 weeks
  • Dietary Supplement: Placebo
    Placebo taken twice a day for 8 weeks
  • Experimental: Vitality product
    Proprietary blend of ginseng, cordyceps, and pomegranate
    Intervention: Dietary Supplement: Vitality Product
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
November 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01155076
10-SUS-03-NU-01
No
Pharmanex
Pharmanex
Sprim Advanced Life Sciences
Principal Investigator: John McGettigan, MD Quality of Life Medical & Research Center, LLC
Pharmanex
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP