Clinical trial NCT00541931: Pilot Investigation of a Multinutrient Supplement on Skin Aging and Aging Metabolites in Healthy Women
Official title: Pilot Investigation of a Multinutrient Supplement on Skin Aging and Aging Metabolites in Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Diseases
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Nu Skin Enterprises
First posted: 2007-10-10
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fold Change in Long Chain Fatty Acids
timeFrame: Baseline; Week 12
measure: Change in Fine Wrinkling
timeFrame: Baseline; week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Anne Lynn S. Chang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.