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OpenTrials
Completed

NCT Number: NCT01155076

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

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

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitality Product

Dietary Supplement

Proprietary blend of ginseng, cordyceps, and pomegranate taken twice a day for 8 weeks

Placebo

Dietary Supplement

Placebo taken twice a day for 8 weeks

Primary outcomes

  1. Health-related quality of life

    Time frame: 8 weeks

Secondary outcomes

  1. Medical Outcomes Study (MOS) Sexual Function questionnaire

    Time frame: 8 weeks

  2. Adverse events

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Pharmanex

Industry

Collaborators

  • Sprim Advanced Life Sciences

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jul 1, 2010
Registry last updated
Nov 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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