Skin Diseases
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGDietary Supplement: LifePak Nano
Daily use
Sponsors
Nu Skin Enterprises
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
- Fitzpatrick Skin type I or II * Nonpregnant Females, age 18-30 or 50-70 * Body Mass Index Normal or Overweight * If age 18-30, must be non-smoker * Willing to fast for 8 hours prior to a blood draw;
Exclusion criteria
- History of cosmetic surgery * Use of anti-aging medications within 3 months of enrollment * Use of over-the-counter anti-aging creams (not sunscreens) more than once per week within one month of enrollment * Use of dietary supplements including vitamins within one month of enrollment * Use of tanning beds or excessive UV exposure (greater than 2 hours per day) within one month of enrollment * Use of sunless tanners within one month of enrollment * Uncontrolled or ongoing serious medical condition * Participation in another clinical study involving use of an investigational drug or product * Medical condition which, at the discretion of the investigator, will have a significant impact on ability to judge participant's skin characteristics, including age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fold Change in Long Chain Fatty Acids | Baseline; Week 12 | 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. |
| Change in Fine Wrinkling | Baseline; week 12 | 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. |
Countries
United States
Participant flow
Recruitment details
Healthy female volunteers in the community aged \>50 years
Participants by arm
| Arm | Count |
|---|---|
| Nonsmoker Nonsmokers Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano: Daily use | 17 |
| Smoker Smoker arm Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano: Daily use | 11 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Transportation Issue | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Nonsmoker | Smoker | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 11 Participants | 28 Participants |
| Age, Continuous | 55.7 years STANDARD_DEVIATION 6.3 | 56.3 years STANDARD_DEVIATION 5 | 56.0 years STANDARD_DEVIATION 5.6 |
| Fine wrinkling as assessed by clinician | 8.35 units on a scale STANDARD_DEVIATION 1.8 | 8.70 units on a scale STANDARD_DEVIATION 1.7 | 8.37 units on a scale STANDARD_DEVIATION 1.75 |
| Region of Enrollment United States | 17 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Female | 17 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 22 | 6 / 15 |
| serious Total, serious adverse events | 0 / 22 | 0 / 15 |
Outcome results
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.
Time frame: Baseline; week 12
Population: Participants completing the protocol were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nonsmoker | Change in Fine Wrinkling | 0.24 units on a scale | Standard Deviation 1.82 |
| Smoker | Change in Fine Wrinkling | -1.77 units on a scale | Standard Deviation 2.74 |
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.
Time frame: Baseline; Week 12
Population: Participants completing the protocol were included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nonsmoker | Fold Change in Long Chain Fatty Acids | 1 Fold Change in long chain fatty acids |
| Smoker | Fold Change in Long Chain Fatty Acids | 0.76 Fold Change in long chain fatty acids |