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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)

Primary Purpose

Anti Aging

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vitality product AM + Vitality product PM
Placebo
Sponsored by
Pharmanex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anti Aging focused on measuring Ginseng, Cordyceps, Pomegranate, Red Orange, Grape Seed, Broccoli Seed

Eligibility Criteria

35 Years - 73 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Aspen Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitality product AM + Vitality product PM

Placebo

Arm Description

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: Placebo Placebo taken twice a day for 8 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Establish a safety profile of investigational supplement
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
Determine effects of investigational supplement on composite cognitive index
Determine changes in scoring on HADS assessment (Hospital Anxiety & Depression Scale)
Questionnaire: Hospital Anxiety and Depression Scale (HADS)
Determine changes in Quality of Life
SF-36 (Quality of Life Assessment)
Determine changes in sleep patterns and quality
Sleep measurement scale.
Determine changes to overall health
Abbreviated Physical Exam
Determine changes to biological age scanning (Digital Pulse Wave Analyzer (DPA)
Digital Pulse Wave Analyzer
Determine changes in Biophotonic Scanner Scores
Measure antioxidants in the palm of the skin.
Determine changes in skin advanced glycation endproducts (AGE) levels
AGE Reader

Full Information

First Posted
May 8, 2012
Last Updated
December 10, 2014
Sponsor
Pharmanex
Collaborators
Aspen Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT01598272
Brief Title
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
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmanex
Collaborators
Aspen Clinical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti Aging
Keywords
Ginseng, Cordyceps, Pomegranate, Red Orange, Grape Seed, Broccoli Seed

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitality product AM + Vitality product PM
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dietary Supplement: Placebo Placebo taken twice a day for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitality product AM + Vitality product PM
Intervention Description
Vitality AM: Tak 6 capsules daily for 56 days Vitality PM: Take 2 capsules daily for 56 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo AM: Take 6 capsules daily for 56 days Placebo PM: Take 2 capsules daily for 56 days
Primary Outcome Measure Information:
Title
Determine effects of investigational supplement on gene expression profiles.
Description
Gene Expression Panel (microarray PBMCs), Inflammatory Panel, Oxidative stress Markers-including glutathione panel and F2 isoprostane, Anti-oxidant panel, and Lipid Panel
Time Frame
Day 0, Day 28, Day 56
Secondary Outcome Measure Information:
Title
Establish a safety profile of investigational supplement
Description
Measure number of participants with adverse events. Fasted Safety Labs (chemistry, hematology, Coagulation)compared to baseline.
Time Frame
Day 0, Day 28, Day 56
Title
Determine effects of investigational supplement on markers of inflammation
Time Frame
Day 0, Day 28, Day 56
Title
Determine effects of investigational supplement on composite cognitive index
Time Frame
Day 0, Day 28, Day 56
Title
Determine changes in scoring on HADS assessment (Hospital Anxiety & Depression Scale)
Description
Questionnaire: Hospital Anxiety and Depression Scale (HADS)
Time Frame
Day 0, Day 28, Day 56
Title
Determine changes in Quality of Life
Description
SF-36 (Quality of Life Assessment)
Time Frame
Day 0, Day 28, Day 56
Title
Determine changes in sleep patterns and quality
Description
Sleep measurement scale.
Time Frame
Day 0, Day 28, Day 56
Title
Determine changes to overall health
Description
Abbreviated Physical Exam
Time Frame
Day 0, Day 28, Day 56
Title
Determine changes to biological age scanning (Digital Pulse Wave Analyzer (DPA)
Description
Digital Pulse Wave Analyzer
Time Frame
Day 0, Day 28, Day 56
Title
Determine changes in Biophotonic Scanner Scores
Description
Measure antioxidants in the palm of the skin.
Time Frame
Day 0, Day 28, Day 56
Title
Determine changes in skin advanced glycation endproducts (AGE) levels
Description
AGE Reader
Time Frame
Day 0, Day 28, Day 56

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Harris, DO
Organizational Affiliation
Aspen Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aspen Clinical Research
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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