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

Skin Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541931
• Other study ID #: 10622
• Status: Completed
• Phase: N/A
• First received: October 5, 2007
• Last updated: November 15, 2017
• Start date: October 2007
• Est. completion date: January 2012

Study information

• Verified date: November 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2012
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Diseases

Intervention

Drug:
• Dietary Supplement: LifePak Nano
Daily use

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Nu Skin Enterprises

Country where clinical trial is conducted

United States, 

References & Publications (1)

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/g — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline; Week 12
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.	Baseline; week 12