Skin DiseasesNCT00541931
Pilot Investigation of a Multinutrient Supplement on Skin Aging and Aging Metabolites in Healthy Women
A study testing Dietary Supplement: LifePak Nano in people with Skin Diseases, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases
- What is being tested?
- Dietary Supplement: LifePak Nano
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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.
Read the 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.
- Conditions
- Skin Diseases
- Being tested
- Dietary Supplement: LifePak Nano
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: LifePak NanoDrug
Also called Life Pak Nano
Daily use
| Study group | Role | What they receive |
|---|---|---|
| Nonsmoker | Other | Nonsmokers Intervention: Dietary Supplement: LifePak Nano Receives: Drug: Dietary Supplement: LifePak Nano |
| Smoker | Other | Smoker arm Intervention: Dietary Supplement: LifePak Nano Receives: Drug: Dietary Supplement: LifePak Nano |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline; week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2008
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Nu Skin Enterprises
- Responsible party
- Principal investigator, Anne Chang, Stanford University
- Investigators
- Dr. Anne Lynn S. Chang, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541931
- Sponsor's protocol ID
- 10622
- Status last verified
- Nov 2017
- First submitted
- 5 Oct 2007
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22360970
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Investigation of a Multinutrient Supplement on Skin Aging and Aging Metabolites in Healthy Women
- ClinicalTrials.gov ID
- NCT00541931
- Acronym / sponsor ID
- 10622
- Conditions
- Skin Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Nu Skin Enterprises
- Study start
- Oct 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Oct 2007 (estimated)
- Results
- Posted 20 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nonsmoker | Other | Drug: Dietary Supplement: LifePak NanoNonsmokers Intervention: Dietary Supplement: LifePak Nano |
| Smoker | Other | Drug: Dietary Supplement: LifePak NanoSmoker arm Intervention: Dietary Supplement: LifePak Nano |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplement: LifePak NanoAlso: Life Pak NanoDaily use | Drug | Nonsmoker, Smoker |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22360970Spitale 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.
Related trials for Skin Diseases
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Anne Lynn S. Chang principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: LifePak Nano in people with Skin Diseases, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fold Change in Long Chain Fatty Acids (time frame: Baseline; Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00541931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.