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

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ClinicalTrials.gov Identifier: NCT00541931
Recruitment Status : Completed
First Posted : October 10, 2007
Results First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Collaborator:
Nu Skin Enterprises
Information provided by (Responsible Party):
Anne Chang, Stanford University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Skin Diseases
Intervention Drug: Dietary Supplement: LifePak Nano
Enrollment 37
Recruitment Details Healthy female volunteers in the community aged >50 years
Pre-assignment Details  
Arm/Group Title Nonsmoker Smoker
Hide Arm/Group Description

Nonsmokers Intervention: Dietary Supplement: LifePak Nano

Dietary Supplement: LifePak Nano : Daily use

Smoker arm Intervention: Dietary Supplement: LifePak Nano

Dietary Supplement: LifePak Nano : Daily use

Period Title: Overall Study
Started 22 15
Completed 17 11
Not Completed 5 4
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             3             3
Withdrawal by Subject             1             0
Transportation Issue             0             1
Arm/Group Title Nonsmoker Smoker Total
Hide Arm/Group Description

Nonsmokers Intervention: Dietary Supplement: LifePak Nano

Dietary Supplement: LifePak Nano: Daily use

Smoker arm Intervention: Dietary Supplement: LifePak Nano

Dietary Supplement: LifePak Nano: Daily use

Total of all reporting groups
Overall Number of Baseline Participants 17 11 28
Hide Baseline Analysis Population Description
Participants completing the protocol were included in the analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 11 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
11
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 11 participants 28 participants
55.7  (6.3) 56.3  (5.0) 56.0  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 11 participants 28 participants
Female
17
 100.0%
11
 100.0%
28
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 17 participants 11 participants 28 participants
17
 100.0%
11
 100.0%
28
 100.0%
Fine wrinkling as assessed by clinician   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 11 participants 28 participants
8.35  (1.80) 8.70  (1.70) 8.37  (1.75)
[1]
Measure Analysis Population 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.
1.Primary Outcome
Title Fold Change in Long Chain Fatty Acids
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing the protocol were included in the analysis.
Arm/Group Title Nonsmoker Smoker
Hide Arm/Group Description:

Nonsmokers Intervention: Dietary Supplement: LifePak Nano

Dietary Supplement: LifePak Nano : Daily use

Smoker arm Intervention: Dietary Supplement: LifePak Nano

Dietary Supplement: LifePak Nano : Daily use

Overall Number of Participants Analyzed 17 11
Mean (Full Range)
Unit of Measure: Fold Change in long chain fatty acids
1
(0 to 1)
0.76
(0 to 1)
2.Primary Outcome
Title Change in Fine Wrinkling
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing the protocol were included in the analysis.
Arm/Group Title Nonsmoker Smoker
Hide Arm/Group Description:

Nonsmokers Intervention: Dietary Supplement: LifePak Nano

Dietary Supplement: LifePak Nano: Daily use

Smoker arm Intervention: Dietary Supplement: LifePak Nano

Dietary Supplement: LifePak Nano: Daily use

Overall Number of Participants Analyzed 17 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.24  (1.82) -1.77  (2.74)
Time Frame Duration of enrollee participation (12 weeks)
Adverse Event Reporting Description All study participants were asked about adverse events at every study visit with results graded and recorded
 
Arm/Group Title Nonsmoker Smoker
Hide Arm/Group Description

Nonsmokers Intervention: Dietary Supplement: LifePak Nano

Dietary Supplement: LifePak Nano : Daily use

Smoker arm Intervention: Dietary Supplement: LifePak Nano

Dietary Supplement: LifePak Nano : Daily use

All-Cause Mortality
Nonsmoker Smoker
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nonsmoker Smoker
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nonsmoker Smoker
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/22 (63.64%)      6/15 (40.00%)    
Musculoskeletal and connective tissue disorders     
Body Aches  1  3/22 (13.64%)  3 3/15 (20.00%)  3
Nervous system disorders     
Headaches  1  11/22 (50.00%)  11 3/15 (20.00%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Sample size limitation, short term nature of study
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Anne Chang, MD
Organization: Stanford University
Phone: (650)721-7151
Responsible Party: Anne Chang, 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