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

Not Applicable

Completed

• Conditions: Health-related Quality of Life
• Interventions: Dietary Supplement: Vitality Product; Dietary Supplement: Placebo

• Registration Number: NCT01155076
• Lead Sponsor: Pharmanex

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-30
• Study Start: 2010-07
• Study First Posted: 2010-07-01
• Primary Completion: 2012-11
• Status Verified: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitality product	Vitality Product	Proprietary blend of ginseng, cordyceps, and pomegranate
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Health-related quality of life	8 weeks

Secondary Outcome Measures

Name	Time	Method
Medical Outcomes Study (MOS) Sexual Function questionnaire	8 weeks
Adverse events	8 weeks

Trial Locations

Locations (3)

Quality of Life Medical and Research Center; 🇺🇸 Tucson, Arizona, United States

Ridgeview Chaska Medical Plaza; 🇺🇸 Chaska, Minnesota, United States

West Houston Clinical Research Services; 🇺🇸 Houston, Texas, United States