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

Health-related Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155076
• Other study ID #: 10-SUS-03-NU-01
• Status: Completed
• Phase: N/A
• First received: June 29, 2010
• Last updated: November 12, 2013
• Start date: July 2010
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Pharmanex
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: November 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Health-related Quality of Life

Intervention

Dietary Supplement:
• Vitality Product
Proprietary blend of ginseng, cordyceps, and pomegranate taken twice a day for 8 weeks
• Placebo
Placebo taken twice a day for 8 weeks

Locations

Country	Name	City	State
United States	Ridgeview Chaska Medical Plaza	Chaska	Minnesota
United States	West Houston Clinical Research Services	Houston	Texas
United States	Quality of Life Medical and Research Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Pharmanex	Sprim Advanced Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life		8 weeks	No
Secondary	Medical Outcomes Study (MOS) Sexual Function questionnaire		8 weeks	No
Secondary	Adverse events		8 weeks	Yes