Pilot Investigation of a Multinutrient Supplement on Skin Aging and Aging Metabolites in Healthy Women
Primary Purpose
Skin Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Supplement: LifePak Nano
Sponsored by
About this trial
This is an interventional treatment trial for Skin Diseases
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.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Nonsmoker
Smoker
Arm Description
Nonsmokers Intervention: Dietary Supplement: LifePak Nano
Smoker arm Intervention: Dietary Supplement: LifePak Nano
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00541931
First Posted
October 5, 2007
Last Updated
November 15, 2017
Sponsor
Stanford University
Collaborators
Nu Skin Enterprises
1. Study Identification
Unique Protocol Identification Number
NCT00541931
Brief Title
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Nu Skin Enterprises
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nonsmoker
Arm Type
Other
Arm Description
Nonsmokers Intervention: Dietary Supplement: LifePak Nano
Arm Title
Smoker
Arm Type
Other
Arm Description
Smoker arm Intervention: Dietary Supplement: LifePak Nano
Intervention Type
Drug
Intervention Name(s)
Dietary Supplement: LifePak Nano
Other Intervention Name(s)
Life Pak Nano
Intervention Description
Daily use
Primary Outcome Measure Information:
Title
Fold Change in Long Chain Fatty Acids
Description
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.
Time Frame
Baseline; Week 12
Title
Change in Fine Wrinkling
Description
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.
Time Frame
Baseline; week 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Anne Lynn S. Chang
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22360970
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.
Results Reference
result
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Pilot Investigation of a Multinutrient Supplement on Skin Aging and Aging Metabolites in Healthy Women
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