Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults
Condition: Skin Health
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Beauty From Within; Placebo; Facial cleansing
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): one scoop of product mixed in 8-16 ounces of water consumed once daily; one scoop of product mixed in 8-16 ounces of water consumed once daily; All subjects will use a cosmetic instrument to clean on one half of their face daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other