Anti AgingPhase 4PharmanexNCT01598272
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
A Phase 4 study testing Vitality product AM + Vitality product PM in people with Anti Aging, run by Pharmanex at 1 site in United States.
Trial summary
Determine the effects of 8 week Investigational Supplement on cellular detoxification and gene expression profiles Read more about this study
- Who is it for?
- Ages 35 to 73 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anti Aging
- What is being tested?
- Vitality product AM + Vitality product PM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jun 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 73 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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.).
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Determine the effects of 8 week Investigational Supplement on cellular detoxification and gene expression profiles
- Conditions
- Anti Aging
- Being tested
- Vitality product AM + Vitality product PM, Placebo
- Keywords
- Ginseng, Cordyceps, Pomegranate, Red Orange, Grape Seed, Broccoli Seed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitality product AM + Vitality product PMDietary supplement
Vitality AM: Tak 6 capsules daily for 56 days Vitality PM: Take 2 capsules daily for 56 days
PlaceboDietary supplement
Placebo AM: Take 6 capsules daily for 56 days Placebo PM: Take 2 capsules daily for 56 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Vitality product AM + Vitality product PM |
| Placebo | Placebo comparator | Dietary Supplement: Placebo Placebo taken twice a day for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0, Day 28, Day 56
Secondary outcomes (10)
Establish a safety profile of investigational supplement
Measure number of participants with adverse events. Fasted Safety Labs (chemistry, hematology, Coagulation)compared to baseline.
Measured: Day 0, Day 28, Day 56
Determine effects of investigational supplement on markers of inflammation
Measured: Day 0, Day 28, Day 56
Determine effects of investigational supplement on composite cognitive index
Measured: Day 0, Day 28, Day 56
Determine changes in scoring on HADS assessment (Hospital Anxiety & Depression Scale)
Questionnaire: Hospital Anxiety and Depression Scale (HADS)
Measured: Day 0, Day 28, Day 56
Determine changes in Quality of Life
SF-36 (Quality of Life Assessment)
Measured: Day 0, Day 28, Day 56
Determine changes in sleep patterns and quality
Sleep measurement scale.
Measured: Day 0, Day 28, Day 56
Determine changes to overall health
Abbreviated Physical Exam
Measured: Day 0, Day 28, Day 56
Determine changes to biological age scanning (Digital Pulse Wave Analyzer (DPA)
Digital Pulse Wave Analyzer
Measured: Day 0, Day 28, Day 56
Determine changes in Biophotonic Scanner Scores
Measure antioxidants in the palm of the skin.
Measured: Day 0, Day 28, Day 56
Determine changes in skin advanced glycation endproducts (AGE) levels
AGE Reader
Measured: Day 0, Day 28, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJul 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aspen Clinical Research
- Responsible party
- Sponsor
- Investigators
- Michael Harris, DO, Principal investigator, Aspen Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598272
- Sponsor's protocol ID
- 11-PHX-03-NU-01
- Acronym
- Pharmanex
- Status last verified
- Dec 2014
- First submitted
- 8 May 2012
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01598272
- Acronym / sponsor ID
- Pharmanex / 11-PHX-03-NU-01
- Conditions
- Anti Aging
- Keywords
- Ginseng, Cordyceps, Pomegranate, Red Orange, Grape Seed, Broccoli Seed
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Collaborators
- Aspen Clinical Research
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the effects of 8 week Investigational Supplement on cellular detoxification and gene expression profiles
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitality product AM + Vitality product PM | Experimental | Dietary Supplement: Vitality product AM + Vitality product PMDietary 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary Supplement: Placebo Placebo taken twice a day for 8 weeks |
Who may qualify
- Ages
- 35 to 73 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitality product AM + Vitality product PMVitality AM: Tak 6 capsules daily for 56 days Vitality PM: Take 2 capsules daily for 56 days | Dietary supplement | Vitality product AM + Vitality product PM |
| PlaceboPlacebo AM: Take 6 capsules daily for 56 days Placebo PM: Take 2 capsules daily for 56 days | Dietary supplement | Placebo |
Primary outcome
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
10 secondary outcomes
Establish a safety profile of investigational supplement
Time frame: Day 0, Day 28, Day 56
Determine effects of investigational supplement on markers of inflammation
Time frame: Day 0, Day 28, Day 56
Determine effects of investigational supplement on composite cognitive index
Time frame: Day 0, Day 28, Day 56
Determine changes in scoring on HADS assessment (Hospital Anxiety & Depression Scale)
Time frame: Day 0, Day 28, Day 56
Determine changes in Quality of Life
Time frame: Day 0, Day 28, Day 56
Determine changes in sleep patterns and quality
Time frame: Day 0, Day 28, Day 56
Determine changes to overall health
Time frame: Day 0, Day 28, Day 56
Determine changes to biological age scanning (Digital Pulse Wave Analyzer (DPA)
Time frame: Day 0, Day 28, Day 56
Determine changes in Biophotonic Scanner Scores
Time frame: Day 0, Day 28, Day 56
Determine changes in skin advanced glycation endproducts (AGE) levels
Time frame: Day 0, Day 28, Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
Related trials for Anti Aging
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion for Aging Frailty
Frailty
Recruiting
Clinical Study to Evaluate the Anti-aging Efficacy and Skin Radiance-enhancing Effect of Dermial®.
Healthy Adult Females
Active, not recruiting
Efficacy and Safety of a Topical Botanical Extract Formulation for Skin Aging
Aging, Dry Skin
Not yet recruiting
Efficacy Validation of Deep Microspicule Cream for Anti-aging and Whitening on Mature Skin
Efficacy Validation of Deep Microspicule Cream for Anti-aging and Whitening on Mature Skin
RecruitingEarly Phase 1
Secretome Treatment for Facial Rejuvenation
Facial Aging, Rejuvenation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Harris, DO principal investigator
Aspen Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitality product AM + Vitality product PM in people with Anti Aging, run by Pharmanex at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine effects of investigational supplement on gene expression profiles. (time frame: Day 0, Day 28, Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.