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

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.

Study Overview

• Status: Completed
• Conditions: Skin Diseases
• Intervention / Treatment: Drug: Dietary Supplement: LifePak Nano

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Nonsmoker; Nonsmokers Intervention: Dietary Supplement: LifePak Nano	Drug: Dietary Supplement: LifePak Nano; Daily use; Other Names: Life Pak Nano
Other: Smoker; Smoker arm Intervention: Dietary Supplement: LifePak Nano	Drug: Dietary Supplement: LifePak Nano; Daily use; Other Names: Life Pak Nano

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Nu Skin Enterprises
• Investigators: Principal Investigator: Dr. Anne Lynn S. Chang, Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 5, 2007
• First Submitted That Met QC Criteria: October 9, 2007
• First Posted (Estimate): October 10, 2007

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 10622 (DAIDS ES)