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Completed

NCT Number: NCT01598272

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

Determine the effects of 8 week Investigational Supplement on cellular detoxification and gene expression profiles

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Key information

Conditions

Age range

35 year–73 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Aspen Clinical Research

Orem, Utah, 84058, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Females aged 35-73 years
  • Signed informed consent
  • BMI between 23 and 35 kg/m2
  • 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
  • BioPhotonic scanner score below 30,000
  • 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.
  • Ability to speak and understand English.
  • 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.
  • Willing to not exercise the morning of your last visit

Exclusion criteria

  • 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 or planning to become pregnant during the course of the study.
  • Antihypertensive medication use.
  • Allergies to any ingredients contained in the Investigational Product.
  • 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).
  • Consumption of herbal supplement known to affect energy levels (e.g., ginseng, cordyceps, licorice, Lycium, pomegranate, etc.).
  • 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).
  • Known iron deficiency anemia.
  • Treatment for insomnia or depression within 30-days prior to the screening visit.
  • 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.
  • Tobacco (e.g. cigarettes, chewing tobacco, pipe, nicotine patches) use within 30-days prior to the screening visit.
  • Planned surgical procedure during the course of the study.
  • 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.
  • Any laboratory value that the investigator deems clinically significant.
  • Currently participating in a weight loss program or planning to go on a weight loss diet during the course of the study.
  • Allergies to egg or dairy products, Vegetarian or unwilling to consuming sausage.

Treatment and study plan

Vitality product AM + Vitality product PM

Dietary Supplement

Vitality AM: Tak 6 capsules daily for 56 days Vitality PM: Take 2 capsules daily for 56 days

Placebo

Dietary Supplement

Placebo AM: Take 6 capsules daily for 56 days Placebo PM: Take 2 capsules daily for 56 days

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Determine effects of investigational supplement on markers of inflammation

    Time frame: Day 0, Day 28, Day 56

  3. Determine effects of investigational supplement on composite cognitive index

    Time frame: Day 0, Day 28, Day 56

  4. 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)

  5. Determine changes in Quality of Life

    Time frame: Day 0, Day 28, Day 56

    SF-36 (Quality of Life Assessment)

  6. Determine changes in sleep patterns and quality

    Time frame: Day 0, Day 28, Day 56

    Sleep measurement scale.

  7. Determine changes to overall health

    Time frame: Day 0, Day 28, Day 56

    Abbreviated Physical Exam

  8. Determine changes to biological age scanning (Digital Pulse Wave Analyzer (DPA)

    Time frame: Day 0, Day 28, Day 56

    Digital Pulse Wave Analyzer

  9. Determine changes in Biophotonic Scanner Scores

    Time frame: Day 0, Day 28, Day 56

    Measure antioxidants in the palm of the skin.

  10. Determine changes in skin advanced glycation endproducts (AGE) levels

    Time frame: Day 0, Day 28, Day 56

    AGE Reader

Sponsors and collaborators

Lead sponsor

Pharmanex

Industry

Collaborators

  • Aspen Clinical Research

Registry information

Official study title

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.

Acronym: Pharmanex

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 15, 2012
Registry last updated
Dec 11, 2014

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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