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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01155076
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : November 14, 2013
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Pharmanex

Study Description
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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

Condition or disease Intervention/treatment Phase
Health-related Quality of Life Dietary Supplement: Vitality Product Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2013

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Health-related quality of life [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Medical Outcomes Study (MOS) Sexual Function questionnaire [ Time Frame: 8 weeks ]
  2. Adverse events [ Time Frame: 8 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155076


Locations
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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
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Principal Investigator: John McGettigan, MD Quality of Life Medical & Research Center, LLC
More Information
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Responsible Party: Pharmanex
ClinicalTrials.gov Identifier: NCT01155076    
Other Study ID Numbers: 10-SUS-03-NU-01
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013