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

NCT00541931 | Completed Results DMC

• 1 other identifier: 10622
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Diseases

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Nonsmoker

OTHER

Nonsmokers Intervention: Dietary Supplement: LifePak Nano

Drug: Dietary Supplement: LifePak Nano

Smoker

OTHER

Smoker arm Intervention: Dietary Supplement: LifePak Nano

Drug: Dietary Supplement: LifePak Nano

Interventions

Dietary Supplement: LifePak Nano DRUG

Daily use

Also known as: Life Pak Nano

Nonsmoker; Smoker

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonpregnant Females, age 18-30 or 50-70
• Body Mass Index Normal or Overweight
• If age 18-30, must be non-smoker

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Nu Skin Enterprises: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related 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/gm313.

  PMID: 22360970 RESULT

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Limitations and Caveats

Sample size limitation, short term nature of study

Results Point of Contact

• Title: Dr. Anne Chang, MD
• Organization: Stanford University

alschang@stanford.edu

(650)721-7151

Study Officials

• Dr. Anne Lynn S. Chang

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 10, 2007
• Study Start: October 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: January 1, 2012
• Last Updated: November 20, 2017
• Results First Posted: November 20, 2017

Record last verified: 2017-11

Locations

US (1)