Trial Outcomes & Findings for Pilot Investigation of a Multinutrient Supplement on Skin Aging and Aging Metabolites in Healthy Women (NCT NCT00541931)
NCT ID: NCT00541931
Last Updated: 2017-11-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
Baseline; Week 12
Results posted on
2017-11-20
Participant Flow
Healthy female volunteers in the community aged \>50 years
Participant milestones
| Measure |
Nonsmoker
Nonsmokers Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano : Daily use
|
Smoker
Smoker arm Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano : Daily use
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
15
|
|
Overall Study
COMPLETED
|
17
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Nonsmoker
Nonsmokers Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano : Daily use
|
Smoker
Smoker arm Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano : Daily use
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Transportation Issue
|
0
|
1
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Nonsmoker
n=17 Participants
Nonsmokers Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano: Daily use
|
Smoker
n=11 Participants
Smoker arm Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano: Daily use
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
56.0 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Fine wrinkling as assessed by clinician
|
8.35 units on a scale
STANDARD_DEVIATION 1.80 • n=5 Participants • 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.
|
8.70 units on a scale
STANDARD_DEVIATION 1.70 • n=7 Participants • 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.
|
8.37 units on a scale
STANDARD_DEVIATION 1.75 • n=5 Participants • 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.
|
PRIMARY outcome
Timeframe: Baseline; Week 12Population: Participants completing the protocol were included in the analysis.
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.
Outcome measures
| Measure |
Nonsmoker
n=17 Participants
Nonsmokers Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano : Daily use
|
Smoker
n=11 Participants
Smoker arm Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano : Daily use
|
|---|---|---|
|
Fold Change in Long Chain Fatty Acids
|
1 Fold Change in long chain fatty acids
Interval 0.0 to 1.0
|
0.76 Fold Change in long chain fatty acids
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: Baseline; week 12Population: Participants completing the protocol were included in the analysis.
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.
Outcome measures
| Measure |
Nonsmoker
n=17 Participants
Nonsmokers Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano : Daily use
|
Smoker
n=11 Participants
Smoker arm Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano : Daily use
|
|---|---|---|
|
Change in Fine Wrinkling
|
0.24 units on a scale
Standard Deviation 1.82
|
-1.77 units on a scale
Standard Deviation 2.74
|
Adverse Events
Nonsmoker
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Smoker
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nonsmoker
n=22 participants at risk
Nonsmokers Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano : Daily use
|
Smoker
n=15 participants at risk
Smoker arm Intervention: Dietary Supplement: LifePak Nano
Dietary Supplement: LifePak Nano : Daily use
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Body Aches
|
13.6%
3/22 • Number of events 3 • Duration of enrollee participation (12 weeks)
All study participants were asked about adverse events at every study visit with results graded and recorded
|
20.0%
3/15 • Number of events 3 • Duration of enrollee participation (12 weeks)
All study participants were asked about adverse events at every study visit with results graded and recorded
|
|
Nervous system disorders
Headaches
|
50.0%
11/22 • Number of events 11 • Duration of enrollee participation (12 weeks)
All study participants were asked about adverse events at every study visit with results graded and recorded
|
20.0%
3/15 • Number of events 3 • Duration of enrollee participation (12 weeks)
All study participants were asked about adverse events at every study visit with results graded and recorded
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place