Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 40 - 60 |
| Updated: | 3/22/2019 |
| Start Date: | May 2019 |
| End Date: | September 2019 |
| Contact: | Gayle Robertson |
| Email: | skinstudy@northstate.net |
| Phone: | 3368412040 |
A Single-center, Placebo Controlled Study to Investigate the Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults
Consumption of dietary supplements has been found to modulate skin health. Individual
ingredients such as collagen peptides, lutein and ceramides have been shown to improve skin
health. Collagen peptides have been shown to clinically improve skin texture, decrease area
of skin ultraviolet damage, increase skin hydration, and improve visible skin results such as
hydration, elasticity, wrinkles and roughness. Lutein has been demonstrated to increase skin
radiance, protect skin from ultraviolet light, and increase skin hydration. Ceramides derived
from wheat have been shown to improve skin texture, increase skin hydration and improve
visible skin attributes such as hydration, elasticity, and wrinkles. This study will have
subjects consuming a nutritional supplement or placebo daily for 90 days to see if there is
an effect on skin health. This study will also have the subjects using a facial cleansing
device, which has been shown to improve skin health, on half of their face to determine if
there is a synergistic effect between dietary supplement and cleansing device. It is
believed, this mixture of collagen peptides, lutein and ceramides has not been studied and
the study sponsor hypothesize that this blend of ingredients will have a positive impact on
skin health.
ingredients such as collagen peptides, lutein and ceramides have been shown to improve skin
health. Collagen peptides have been shown to clinically improve skin texture, decrease area
of skin ultraviolet damage, increase skin hydration, and improve visible skin results such as
hydration, elasticity, wrinkles and roughness. Lutein has been demonstrated to increase skin
radiance, protect skin from ultraviolet light, and increase skin hydration. Ceramides derived
from wheat have been shown to improve skin texture, increase skin hydration and improve
visible skin attributes such as hydration, elasticity, and wrinkles. This study will have
subjects consuming a nutritional supplement or placebo daily for 90 days to see if there is
an effect on skin health. This study will also have the subjects using a facial cleansing
device, which has been shown to improve skin health, on half of their face to determine if
there is a synergistic effect between dietary supplement and cleansing device. It is
believed, this mixture of collagen peptides, lutein and ceramides has not been studied and
the study sponsor hypothesize that this blend of ingredients will have a positive impact on
skin health.
Visit 1 Screening (day -30 to -1): Subjects will be given a copy of the informed consent
document. They will be given ample time to read and formulate questions prior to reviewing
the document with study staff. The consent form will be reviewed with the subject and
questions will be answered. The subject will provide written consent prior to starting any
study related assessments. The study staff will collect the following information during this
visit:
- Review medical history
- Review concomitant medications
- Measure height, weight, BMI, heart rate, blood pressure
- Review inclusion/exclusion criteria
If the subject meets inclusion/exclusion criteria they will complete the following study
assessments.
- Skin examination
- Investigator facial clinical grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Digital photo of face
Visit 2 Baseline (day 0): Subjects will return to the research site for baseline visit
approximately 30 days after their screening visit. Subjects will undergo assessments to
determine that they continue to meet inclusion/exclusion criteria. Subjects who are eligible
will be enrolled into the study and assigned a randomization number and study product. The
following assessments will be completed during this visit:
- Measure weight, BMI, heart rate, blood pressure
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- 10ml Blood draw (Chemistry and CBC)
- Digital photo of face
- UV Radiation of buttocks (1MED, 2MED, 3MED)
Visit 3 Baseline + 24hrs (day 1): Subjects will return to the research site approximately
24hrs after their baseline visit. The following assessments will be completed during this
visit:
- Digital photograph of irradiated buttock site
- Dermospectrophotometer of irradiated site
- Dispense 2 months of assigned study product
- Dispense skin cleansing machine and provide instruction on daily use to the right half
of their face only
Visit 4 (day 30 +5 days): Subjects will return at approximately 30 days after their baseline
visit. Unused study product will be collected and compliance will be calculated. The
following assessments will be completed:
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Adverse events will be collected by asking if the subject has experienced any changes in
their health
- Return unused study product and dispense enough assigned study product to make it
through next study visit
Visit 5 (day 60 +5 days): Subjects will return at approximately 60 days after their baseline
visit. Unused study product will be collected and compliance will be calculated. The
following assessments will be completed:
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Adverse events will be collected by asking if the subject has experienced any changes in
their health
- Return unused study product and dispense enough assigned study product to make it
through next study visit
Visit 6 (day 90 +5 days): Subjects will return at approximately 90 days after their baseline
visit. Unused study product will be collected and compliance will be calculated. The
following assessments will be completed:
- Measure weight, BMI, heart rate, blood pressure
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- 10ml Blood draw (Chemistry and CBC)
- Digital photo of face
- UV Radiation of buttocks (1MED, 2MED, 3MED)
- Collect skin cleansing machine
- Adverse events will be collected by asking if the subject has experienced any changes in
their health
Visit 7 (24 hours after visit 6): Subjects will return to the research site approximately
24hrs after visit 6. The following assessments will be completed during this visit:
- Digital photograph of irradiated buttock site
- Dermospectrophotometer of irradiated site
document. They will be given ample time to read and formulate questions prior to reviewing
the document with study staff. The consent form will be reviewed with the subject and
questions will be answered. The subject will provide written consent prior to starting any
study related assessments. The study staff will collect the following information during this
visit:
- Review medical history
- Review concomitant medications
- Measure height, weight, BMI, heart rate, blood pressure
- Review inclusion/exclusion criteria
If the subject meets inclusion/exclusion criteria they will complete the following study
assessments.
- Skin examination
- Investigator facial clinical grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Digital photo of face
Visit 2 Baseline (day 0): Subjects will return to the research site for baseline visit
approximately 30 days after their screening visit. Subjects will undergo assessments to
determine that they continue to meet inclusion/exclusion criteria. Subjects who are eligible
will be enrolled into the study and assigned a randomization number and study product. The
following assessments will be completed during this visit:
- Measure weight, BMI, heart rate, blood pressure
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- 10ml Blood draw (Chemistry and CBC)
- Digital photo of face
- UV Radiation of buttocks (1MED, 2MED, 3MED)
Visit 3 Baseline + 24hrs (day 1): Subjects will return to the research site approximately
24hrs after their baseline visit. The following assessments will be completed during this
visit:
- Digital photograph of irradiated buttock site
- Dermospectrophotometer of irradiated site
- Dispense 2 months of assigned study product
- Dispense skin cleansing machine and provide instruction on daily use to the right half
of their face only
Visit 4 (day 30 +5 days): Subjects will return at approximately 30 days after their baseline
visit. Unused study product will be collected and compliance will be calculated. The
following assessments will be completed:
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Adverse events will be collected by asking if the subject has experienced any changes in
their health
- Return unused study product and dispense enough assigned study product to make it
through next study visit
Visit 5 (day 60 +5 days): Subjects will return at approximately 60 days after their baseline
visit. Unused study product will be collected and compliance will be calculated. The
following assessments will be completed:
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- Adverse events will be collected by asking if the subject has experienced any changes in
their health
- Return unused study product and dispense enough assigned study product to make it
through next study visit
Visit 6 (day 90 +5 days): Subjects will return at approximately 90 days after their baseline
visit. Unused study product will be collected and compliance will be calculated. The
following assessments will be completed:
- Measure weight, BMI, heart rate, blood pressure
- Investigator facial clinical grading
- Subject facial grading
- Corneometry of both sides of the face and one forearm
- Colorimeter of both sides of the face and one forearm
- Elasticity of both sides of the face
- Carotenoid scan of left hand
- AGE reader of left forearm
- 10ml Blood draw (Chemistry and CBC)
- Digital photo of face
- UV Radiation of buttocks (1MED, 2MED, 3MED)
- Collect skin cleansing machine
- Adverse events will be collected by asking if the subject has experienced any changes in
their health
Visit 7 (24 hours after visit 6): Subjects will return to the research site approximately
24hrs after visit 6. The following assessments will be completed during this visit:
- Digital photograph of irradiated buttock site
- Dermospectrophotometer of irradiated site
Inclusion Criteria:
1. Males and females 40 - 60 years of age
2. Individuals must present with stable moderate signs of aging that does not change
between the screening visit and the baseline visit 4 weeks later
3. Subject is willing and able to participate in all aspects of the study
4. Individuals must sign informed consent, photo release consent and confidentiality
agreement
5. Subject has a BMI > 19 and < 32
6. Subject must be on a stable dose of chronic use medications for at least 3 months
prior to study participation
7. Subject who, in the opinion of the investigator, are free of any medical condition(s)
that may interfere with study participation or affect study measures
Exclusion Criteria:
1. Individuals that are being treated for cancer or have a history of facial skin cancer
2. Individuals with sunburn, moderate to pronounced suntan, uneven skin tones, tattoos,
scares or other disfiguration, dilated vessels or other conditions on the test area
that might influence the test results
3. Any disease or condition of the skin that the investigator deems inappropriate for
participation, including rosacea, eczema, psoriasis, and atopic dermatitis
4. Individuals currently taking medications which in the opinion of the investigator may
interfere with the study. This would include but not be limited to all oral
corticosteroids, use of anti-inflammatory drugs more than 14 consecutive days,
immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye
drops are permitted), hormone replacement therapy and insulin, antibiotics or other
topical drugs at the test sites
5. Individuals with uncontrolled metabolic diseases such as diabetes (type I and II),
hypertension, hyperthyroidism or hypothyroidism, severe chronic asthma, immunological
disorders such as HIV, AIDS and systemic lupus erythematosus or mastectomy for cancer
involving removal of lymph nodes
6. Subject is taking skin, nail, and hair health promoting supplement orally (including
products containing collagen and carotenoids)
7. Women known to be pregnant, nursing, or planning to become pregnant
8. Individuals participating in other facial clinical trials
9. Individuals who have routinely used alpha-hydroxy-acid (AHA) or a beta-hydroxy-acid
(BHA) containing product within two weeks of baseline visit or Retin-A®, Retin-A
Micro®, Renova®, Differin®, Avita®, Tazorac®, or Soriatane® within one month of
baseline visit or have taken Accutane® within one year of baseline visit. Individuals
who have used Retinol in the last six months prior to baseline visit
10. Individuals with inflammatory acne lesions (i.e., papules, pustules, cysts, nodules)
at the test site
11. Individuals who have had chemical peels or dermabrasion within the last six months
prior to baseline visit
12. Individuals who have sun tanned (sun or tanning beds) in the nude within the past 1
year prior to baseline visit
13. Excessive alcohol use (>2 drinks per day)
14. Subject is a current smoker or quit less than 3 years from screening visit
15. History of substance abuse
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