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| Name | Class |
|---|---|
| Nu Skin Enterprises | INDUSTRY |
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We are seeking healthy female volunteers to determine if multinutrient supplementation affects visible signs of skin aging as well as blood measurements of aging. We are seeking smokers and non-smokers.
Skin antioxidant levels as well as blood metabolites may change as the human body ages1,2. Although the chronological aging process is unstoppable, the physical signs of aging, particularly characteristics of the skin, may be delayed through a variety of medical interventions such as topical medications or resurfacing lasers. It is not currently known whether skin carotenoid antioxidant levels correlate with skin aging characteristics, although studies with other antioxidants suggest this may be true 3. In addition, while selected blood metabolites correlate with changes in age2, we do not know if this correlates with skin changes. Our current study focuses on whether differences in skin carotenoid levels and blood metabolite levels correlate with skin aging characteristics in age-matched subjects. Furthermore, we will explore whether three months consumption with a commercial multi-nutrient formulation (LifePak Nano) affects metabolic markers of aging, skin aging characteristics including skin elasticity and transepidermal water loss. We will also examine whether smokers respond differently from nonsmokers in the above parameters after supplementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonsmoker | Other | Nonsmokers Intervention: Dietary Supplement: LifePak Nano |
|
| Smoker | Other | Smoker arm Intervention: Dietary Supplement: LifePak Nano |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement: LifePak Nano | Drug | Daily use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fold Change in Long Chain Fatty Acids | Peripheral blood long chain fatty acids were measured. Fold change of 1 = no difference; if metabolites decrease at week 12 from baseline, the fold change will be <1. | Baseline; Week 12 |
| Change in Fine Wrinkling | Assessed by 4 dermatologists blinded to chronological age and smoking status, on a 10-point Likert scale (min 1/max 10); lower scores indicate less wrinkling and higher scores indicate more wrinkling. Values are the average of scores given by the four raters. Change was calculated as the baseline value minus the week 12 value. | Baseline; week 12 |
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Inclusion Criteria:- Fitzpatrick Skin type I or II
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Anne Lynn S. Chang | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22360970 | Result | Spitale RC, Cheng MY, Chun KA, Gorell ES, Munoz CA, Kern DG, Wood SM, Knaggs HE, Wulff J, Beebe KD, Chang AL. Differential effects of dietary supplements on metabolomic profile of smokers versus non-smokers. Genome Med. 2012 Feb 23;4(2):14. doi: 10.1186/gm313. |
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Healthy female volunteers in the community aged >50 years
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| ID | Title | Description |
|---|---|---|
| FG000 | Nonsmoker | Nonsmokers Intervention: Dietary Supplement: LifePak Nano Dietary Supplement: LifePak Nano : Daily use |
| FG001 | Smoker | Smoker arm Intervention: Dietary Supplement: LifePak Nano Dietary Supplement: LifePak Nano : Daily use |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants completing the protocol were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nonsmoker | Nonsmokers Intervention: Dietary Supplement: LifePak Nano Dietary Supplement: LifePak Nano: Daily use |
| BG001 | Smoker | Smoker arm Intervention: Dietary Supplement: LifePak Nano Dietary Supplement: LifePak Nano: Daily use |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fold Change in Long Chain Fatty Acids | Peripheral blood long chain fatty acids were measured. Fold change of 1 = no difference; if metabolites decrease at week 12 from baseline, the fold change will be <1. | Participants completing the protocol were included in the analysis. | Posted | Mean | Full Range | Fold Change in long chain fatty acids | Baseline; Week 12 |
|
Duration of enrollee participation (12 weeks)
All study participants were asked about adverse events at every study visit with results graded and recorded
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nonsmoker | Nonsmokers Intervention: Dietary Supplement: LifePak Nano Dietary Supplement: LifePak Nano : Daily use |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Body Aches | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
Sample size limitation, short term nature of study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Chang, MD | Stanford University | (650)721-7151 | alschang@stanford.edu |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| Withdrawal by Subject |
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| Transportation Issue |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Fine wrinkling as assessed by clinician | Assessed by 4 dermatologists blinded to chronological age and smoking status, on a 10-point Likert scale (min 1/max 10); lower scores indicate less wrinkling and higher scores indicate more wrinkling. Values are the average of scores given by the four raters. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Change in Fine Wrinkling | Assessed by 4 dermatologists blinded to chronological age and smoking status, on a 10-point Likert scale (min 1/max 10); lower scores indicate less wrinkling and higher scores indicate more wrinkling. Values are the average of scores given by the four raters. Change was calculated as the baseline value minus the week 12 value. | Participants completing the protocol were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline; week 12 |
|
|
|
| 0 |
| 22 |
| 14 |
| 22 |
| EG001 | Smoker | Smoker arm Intervention: Dietary Supplement: LifePak Nano Dietary Supplement: LifePak Nano : Daily use | 0 | 15 | 6 | 15 |
| Headaches | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
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