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Effects of a Proprietary Blend of Herbal Extract Supplement on Cellular Detoxification, Inflammation, and Cumulative Cognitive Index as Well as Gene Expression in Middle-Aged Adult Women (Pharmanex)

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ClinicalTrials.gov Identifier: NCT01598272
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : December 11, 2014
Sponsor:
Collaborator:
Aspen Clinical Research
Information provided by (Responsible Party):
Pharmanex

Tracking Information
First Submitted Date  ICMJE May 8, 2012
First Posted Date  ICMJE May 15, 2012
Last Update Posted Date December 11, 2014
Study Start Date  ICMJE July 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2012)
Determine effects of investigational supplement on gene expression profiles. [ Time Frame: Day 0, Day 28, Day 56 ]
Gene Expression Panel (microarray PBMCs), Inflammatory Panel, Oxidative stress Markers-including glutathione panel and F2 isoprostane, Anti-oxidant panel, and Lipid Panel
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2012)
  • Establish a safety profile of investigational supplement [ Time Frame: Day 0, Day 28, Day 56 ]
    Measure number of participants with adverse events. Fasted Safety Labs (chemistry, hematology, Coagulation)compared to baseline.
  • Determine effects of investigational supplement on markers of inflammation [ Time Frame: Day 0, Day 28, Day 56 ]
  • Determine effects of investigational supplement on composite cognitive index [ Time Frame: Day 0, Day 28, Day 56 ]
  • Determine changes in scoring on HADS assessment (Hospital Anxiety & Depression Scale) [ Time Frame: Day 0, Day 28, Day 56 ]
    Questionnaire: Hospital Anxiety and Depression Scale (HADS)
  • Determine changes in Quality of Life [ Time Frame: Day 0, Day 28, Day 56 ]
    SF-36 (Quality of Life Assessment)
  • Determine changes in sleep patterns and quality [ Time Frame: Day 0, Day 28, Day 56 ]
    Sleep measurement scale.
  • Determine changes to overall health [ Time Frame: Day 0, Day 28, Day 56 ]
    Abbreviated Physical Exam
  • Determine changes to biological age scanning (Digital Pulse Wave Analyzer (DPA) [ Time Frame: Day 0, Day 28, Day 56 ]
    Digital Pulse Wave Analyzer
  • Determine changes in Biophotonic Scanner Scores [ Time Frame: Day 0, Day 28, Day 56 ]
    Measure antioxidants in the palm of the skin.
  • Determine changes in skin advanced glycation endproducts (AGE) levels [ Time Frame: Day 0, Day 28, Day 56 ]
    AGE Reader
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Proprietary Blend of Herbal Extract Supplement on Cellular Detoxification, Inflammation, and Cumulative Cognitive Index as Well as Gene Expression in Middle-Aged Adult Women
Official Title  ICMJE A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single-Center Study on the Effects of a Proprietary Blend of Herbal Extract Supplement on Cellular Detoxification, Inflammation, and Cumulative Cognitive Index as Well as Gene Expression in Middle-Aged Adult Women.
Brief Summary Determine the effects of 8 week Investigational Supplement on cellular detoxification and gene expression profiles
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Anti Aging
Intervention  ICMJE
  • Dietary Supplement: Vitality product AM + Vitality product PM
    Vitality AM: Tak 6 capsules daily for 56 days Vitality PM: Take 2 capsules daily for 56 days
  • Dietary Supplement: Placebo
    Placebo AM: Take 6 capsules daily for 56 days Placebo PM: Take 2 capsules daily for 56 days
Study Arms  ICMJE
  • Experimental: Vitality product AM + Vitality product PM

    Dietary Supplement:

    Proprietary blend of ginseng, cordyceps, and pomegranate + proprietary blend of broccoli seed, red orange, and grape seed taken twice a day for 8 weeks.

    Intervention: Dietary Supplement: Vitality product AM + Vitality product PM
  • Placebo Comparator: Placebo
    Dietary Supplement: Placebo Placebo taken twice a day for 8 weeks
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2014)
95
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2012)
90
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Females aged 35-73 years
  2. Signed informed consent
  3. BMI between 23 and 35 kg/m2
  4. A resting normotensive blood pressure is defined as a systolic blood pressure between 90-145 mmHg and a diastolic blood pressure of 50 90 mmHg
  5. BioPhotonic scanner score below 30,000
  6. Use of effective method of contraception by females of childbearing [potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study]. Acceptable methods of contraception include oral, injectable, or implantable contraceptives; intrauterine devices, diaphragm plus spermicide; or any double barrier method. Women who have had a hysterectomy or tubal ligation at least 6 months prior to Visit 1 or who have been post-menopausal for at least 1 year prior to Visit 1 are not considered to be of childbearing potential.
  7. Ability to speak and understand English.
  8. Willing to consume one high-fat high carbohydrate meal at the last visit consisting of 1 McDonald's egg Mcmuffin with cheese (no meat), 1 Sausage McMuffin with cheese (no egg), 2 hashbrowns, 1 12 oz Coke Cola or Sprite.
  9. Willing to not exercise the morning of your last visit

Exclusion Criteria:

  1. Self-reported chronic condition that may affect subject safety (e.g., diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g., chronic fatigue)
  2. Pregnancy/suspected pregnancy, breastfeeding or planning to become pregnant during the course of the study.
  3. Antihypertensive medication use.
  4. Allergies to any ingredients contained in the Investigational Product.
  5. Consumption of more than 600 mg of caffeine from all sources per day (equivalent to 24 oz. caffeinated coffee, 96 oz. of soda, 60 oz. of tea, 60 oz. energy drinks , or a combination thereof).
  6. Consumption of herbal supplement known to affect energy levels (e.g., ginseng, cordyceps, licorice, Lycium, pomegranate, etc.).
  7. Consumption of any of the supplements included in the formulas (Cordyceps sinensis, Panax Ginseng extract, pomegranate extract, red orange complex, grape seed extract or broccoli seed extract).
  8. Known iron deficiency anemia.
  9. Treatment for insomnia or depression within 30-days prior to the screening visit.
  10. Recently started taking medication known to effect energy (e.g., thyroid medication). If taking medication (e.g., thyroid medication), must be stable for at least four months.
  11. Tobacco (e.g. cigarettes, chewing tobacco, pipe, nicotine patches) use within 30-days prior to the screening visit.
  12. Planned surgical procedure during the course of the study.
  13. Currently participating in another study or have done so within 30 days prior to the screening visit or is likely to enroll in another clinical or nutritional study.
  14. Any laboratory value that the investigator deems clinically significant.
  15. Currently participating in a weight loss program or planning to go on a weight loss diet during the course of the study.
  16. Allergies to egg or dairy products, Vegetarian or unwilling to consuming sausage.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years to 73 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01598272
Other Study ID Numbers  ICMJE 11-PHX-03-NU-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pharmanex
Study Sponsor  ICMJE Pharmanex
Collaborators  ICMJE Aspen Clinical Research
Investigators  ICMJE
Principal Investigator: Michael Harris, DO Aspen Clinical Research
PRS Account Pharmanex
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP