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

NCT01598272 | Completed Phase 4 DMC

• 1 other identifier: 11-PHX-03-NU-01
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anti Aging

Keywords

Ginseng; Cordyceps; Pomegranate; Red Orange; Grape Seed; Broccoli Seed

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Establish a safety profile of investigational supplement

  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)

  Day 0, Day 28, Day 56

• Determine changes in Quality of Life

  Day 0, Day 28, Day 56

Study Arms (2)

Vitality product AM + Vitality product PM

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo Placebo taken twice a day for 8 weeks

Dietary Supplement: Placebo

Interventions

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

Vitality product AM + Vitality product PM

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 35 Years - 73 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharmanex: lead
• Aspen Clinical Research: collaborator

Study Sites (1)

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

Study Officials

• Michael Harris, DO

  Aspen Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 15, 2012
• Study Start: July 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

US (1)