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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00541931
First Posted: October 10, 2007
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nu Skin Enterprises
Information provided by (Responsible Party):
Anne Chang, Stanford University
  Purpose
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.

Condition Intervention
Skin Diseases Drug: Dietary Supplement: LifePak Nano

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Investigation of a Multinutrient Supplement on Skin Aging and Aging Metabolites in Healthy Women

Resource links provided by NLM:


Further study details as provided by Anne Chang, Stanford University:

Primary Outcome Measures:
  • Fold Change in Long Chain Fatty Acids [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 37
Study Start Date: October 2007
Study Completion Date: January 2012
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nonsmoker
Nonsmokers Intervention: Dietary Supplement: LifePak Nano
Drug: Dietary Supplement: LifePak Nano
Daily use
Other Name: Life Pak Nano
Smoker
Smoker arm Intervention: Dietary Supplement: LifePak Nano
Drug: Dietary Supplement: LifePak Nano
Daily use
Other Name: Life Pak 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541931


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Nu Skin Enterprises
Investigators
Principal Investigator: Dr. Anne Lynn S. Chang Stanford University
  More Information

Publications:
Responsible Party: Anne Chang, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00541931     History of Changes
Other Study ID Numbers: 10622
First Submitted: October 5, 2007
First Posted: October 10, 2007
Results First Submitted: February 5, 2015
Results First Posted: November 20, 2017
Last Update Posted: November 20, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Skin Diseases