Nutritional Supplement Efficacy on Cellular Protection and Skin Health in Generally Healthy Adults
Condition: Skin Health
Study type: Interventional

Summary: 
      Healthy skin has been equated with a healthy diet leading to the "inside out" approach to
      skin health. Since the skin is the barrier to the external world, healthy skin should lead to
      overall better health. Conversely, the skin derives its nutrition from the internal body
      requiring the consumption of nutritional supplements for optimal health. This research
      attempts to examine skin attributes and improved appearance achieved after consumption of a
      state-of-the-art dietary supplement.
    

Detailed description: 
      Subjects will present to the research center and complete an informed consent. They will
      undergo assessment for inclusion/exclusion criteria, skin examination, BMI calculation, and a
      brief medical history. Subjects that are found to be appropriate for study entry will undergo
      an investigator and subject facial evaluation. In addition, they will undergo noninvasive
      measurements of TEWL, corneometry, skin elasticity, dermspectrophotometry, and assessment
      with a biophotonic scanner. Facial photography will also be performed. A target site on the
      right or left sun protected buttock will be selected and will receive 1, 2, and 3 MED of
      solar simulated radiation.

      Subjects will return to the research center 24 hours after irradiation for photography and
      erythema scaledermospectrophotometer measurement of the irradiated sites and biopsy of the 2
      - 3 MED sites. The MED biopsy site will be consistent for each subject, but will be chosen
      based on the amount of achieved erythema. A 2mm punch biopsy will be taken of the irradiated
      site and another adjacent nonirradiated site for a total of 2 skin biopsies that will be
      closed with 5-0 nylon sutures. The biopsy from the nonirradiated site will be processed and
      shipped as instructed by the sponsor to a laboratory for epigenetic analysis. All subjects
      will be dispensed the supplement in a white bottle with a research center label along with a
      compliance diary. Subjects will return in 2 weeks just for suture removal.

      At week 4, subjects will undergo an investigator and subject facial evaluation. In addition,
      they will undergo noninvasive measurements of TEWL, corneometry, skin elasticity,
      dermspectrophotometry, and assessment with a biophotonic scanner. Subjects will be
      redispensed study supplements.

      Subjects will return to the research facility at week 8 and undergo noninvasive measurements
      of TEWL, corneometry, skin elasticity, dermspectrophotometry, and assessment with a
      biophotonic scanner. A target site on the right or left sun protected buttock will be
      selected and will receive 1, 2, and 3 MED of solar simulated radiation. All supplement
      bottles and unused product will be collected. Subjects will return to the research center 24
      hours after irradiation for photography and erythema scale dermospectrophotometer measurement
      of the irradiated sites and biopsy of the 2-3 MED sites. The biopsy site will be the same
      MEDs as the original biopsy site at baseline. A 2mm punch biopsy will be taken of the
      irradiated site and another adjacent nonirradiated site for a total of 2 skin biopsies that
      will be closed with 5-0 nylon sutures. The biopsy from the nonirradiated site will be
      processed and shipped as instructed by the sponsor to a laboratory for epigenetic analysis.
      All supplement bottles and unused product will be collected. All bottles and unused product
      will be returned to the sponsor.

      Subjects will return to the research center at week 10 for suture removal only.
    

Intervention name(s): Nutritional Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): 2 Hard-shell liquid capsules taken twice daily with breakfast and dinner.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other