Pilot Investigation of a Multinutrient Supplement on Skin Aging and Aging Metabolites in Healthy Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Investigation of a Multinutrient Supplement on Skin Aging and Aging Metabolites in Healthy Women

Conditions
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Skin Diseases

Intervention / Treatment
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* Drug: Dietary Supplement: LifePak Nano


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nonsmoker<br>Nonsmokers Intervention: Dietary Supplement: LifePak Nano | Drug: Dietary Supplement: LifePak Nano<br>* Daily use<br>* Other names: Life Pak Nano;|
| Other: Smoker<br>Smoker arm Intervention: Dietary Supplement: LifePak Nano | Drug: Dietary Supplement: LifePak Nano<br>* Daily use<br>* Other names: Life Pak Nano;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |