Clinical trial 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
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anti Aging
Keywords: Ginseng
Cordyceps
Pomegranate
Red Orange
Grape Seed
Broccoli Seed
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
Collaborators: name: Aspen Clinical Research
First posted: 2012-05-15
Enrollment: 95
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Determine effects of investigational supplement on gene expression profiles.
timeFrame: Day 0, Day 28, Day 56
Secondary outcomes:
measure: Establish a safety profile of investigational supplement
timeFrame: Day 0, Day 28, Day 56
measure: Determine effects of investigational supplement on markers of inflammation
timeFrame: Day 0, Day 28, Day 56
measure: Determine effects of investigational supplement on composite cognitive index
timeFrame: Day 0, Day 28, Day 56
measure: Determine changes in scoring on HADS assessment (Hospital Anxiety & Depression Scale)
timeFrame: Day 0, Day 28, Day 56
measure: Determine changes in Quality of Life
timeFrame: Day 0, Day 28, Day 56
measure: Determine changes in sleep patterns and quality
timeFrame: Day 0, Day 28, Day 56
measure: Determine changes to overall health
timeFrame: Day 0, Day 28, Day 56
measure: Determine changes to biological age scanning (Digital Pulse Wave Analyzer (DPA)
timeFrame: Day 0, Day 28, Day 56
measure: Determine changes in Biophotonic Scanner Scores
timeFrame: Day 0, Day 28, Day 56
measure: Determine changes in skin advanced glycation endproducts (AGE) levels
timeFrame: Day 0, Day 28, Day 56
Other outcomes:
Locations:
city: Orem
country: United States
facility: Aspen Clinical Research
state: Utah
Study officials:
affiliation: Aspen Clinical Research
name: Michael Harris, DO
role: PRINCIPAL_INVESTIGATOR
References: