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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
  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
Health-related Quality of Life
Dietary Supplement: Vitality Product
Dietary Supplement: Placebo

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 ]

Enrollment: 116
Study Start Date: July 2010
Study Completion Date: November 2013
Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 12, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014