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

Study Overview

• Status: Completed
• Conditions: Health-related Quality of Life
• Intervention / Treatment: Dietary supplement: Vitality Product; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Quality of Life Medical and Research Center
  • Minnesota
    • Chaska, Minnesota, United States, 55318
      • Ridgeview Chaska Medical Plaza
  • Texas
    • Houston, Texas, United States, 77055
      • West Houston Clinical Research Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo taken twice a day for 8 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Health-related quality of life	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	8 weeks
Medical Outcomes Study (MOS) Sexual Function questionnaire	8 weeks

Collaborators and Investigators

• Sponsor: Pharmanex
• Collaborators: Sprim Advanced Life Sciences
• Investigators: Principal Investigator: John McGettigan, MD, Quality of Life Medical & Research Center, LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: June 30, 2010
• First Posted (Estimate): July 1, 2010

Study Record Updates

• Last Update Posted (Estimate): November 14, 2013
• Last Update Submitted That Met QC Criteria: November 12, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 10-SUS-03-NU-01