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)

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.

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

Study Overview

• Status: Completed
• Conditions: Anti Aging
• Intervention / Treatment: Dietary supplement: Vitality product AM + Vitality product PM; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Utah
    • Orem, Utah, United States, 84058
      • Aspen Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 73 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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
Placebo Comparator: Placebo; Dietary Supplement: Placebo Placebo taken twice a day for 8 weeks	Dietary supplement: Placebo; Placebo AM: Take 6 capsules daily for 56 days Placebo PM: Take 2 capsules daily for 56 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine effects of investigational supplement on gene expression profiles.	Gene Expression Panel (microarray PBMCs), Inflammatory Panel, Oxidative stress Markers-including glutathione panel and F2 isoprostane, Anti-oxidant panel, and Lipid Panel	Day 0, Day 28, Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish a safety profile of investigational supplement	Measure number of participants with adverse events. Fasted Safety Labs (chemistry, hematology, Coagulation)compared to baseline.	Day 0, Day 28, Day 56
Determine effects of investigational supplement on markers of inflammation		Day 0, Day 28, Day 56
Determine effects of investigational supplement on composite cognitive index		Day 0, Day 28, Day 56
Determine changes in scoring on HADS assessment (Hospital Anxiety & Depression Scale)	Questionnaire: Hospital Anxiety and Depression Scale (HADS)	Day 0, Day 28, Day 56
Determine changes in Quality of Life	SF-36 (Quality of Life Assessment)	Day 0, Day 28, Day 56
Determine changes in sleep patterns and quality	Sleep measurement scale.	Day 0, Day 28, Day 56
Determine changes to overall health	Abbreviated Physical Exam	Day 0, Day 28, Day 56
Determine changes to biological age scanning (Digital Pulse Wave Analyzer (DPA)	Digital Pulse Wave Analyzer	Day 0, Day 28, Day 56
Determine changes in Biophotonic Scanner Scores	Measure antioxidants in the palm of the skin.	Day 0, Day 28, Day 56
Determine changes in skin advanced glycation endproducts (AGE) levels	AGE Reader	Day 0, Day 28, Day 56

Collaborators and Investigators

• Sponsor: Pharmanex
• Collaborators: Aspen Clinical Research
• Investigators: Principal Investigator: Michael Harris, DO, Aspen Clinical Research

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 8, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Estimate): December 11, 2014
• Last Update Submitted That Met QC Criteria: December 10, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Pomegranate; Ginseng; Grape Seed; Cordyceps; Red Orange; Broccoli Seed
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 11-PHX-03-NU-01