Effectiveness of a Novel Dietary Ingredient on Hair Growth and Skin's Appearance

Inclusion Criteria:

• Individuals with self-reported concerns with the appearance of their hair and/or skin (i.e., history of breaking hair / wrinkles or discoloration of the skin).
• In good general health as determined by ALS staff.
• Individuals who, at baseline, are free of any dermatological or systemic disorder,which would interfere with the results, at the discretion of the Investigator.
• Individuals who agree to provide a comprehensive medical history and concomitantmedication list for review by ALS staff.
• Individuals who will read, understand and sign an informed consent document andphotography release form.
• Individuals who agree to use the test product as instructed by the testing facilityand complete the full course of the study.
• Individuals who agree to maintain a stable lifestyle with no significant changes indiet, supplements, medications, or exercise routine.
• Individuals who agree to maintain a consistent routine of washing their hair and skin.
• Individuals with natural hair only at start and for the duration of trial (noextensions, weaves, pieces, etc.). Dyed hair will be permitted for individuals whoagree to maintain the same hair color for the study duration.
• Individuals who have not participated in another clinical study or for the past 30days and agree to not concurrently participate in any other studies.
• Individuals who will agree to continue to use their current personal care products (e.g. shampoo, conditioner, hair spray, mousse, lotions, creams, sunscreen, cosmetics,etc.) for the duration of the study and agree to not incorporate any new products withthe exception of those provided by ALS. Subjects must have a safe use history of theircurrent products for at least 30 days prior to screening.
• Individuals who agree to maintain the same length, hair styling and coloring practicesfor the duration of the study.
• Individuals who agree not to utilize any new over the counter, commercial or otherproducts that are marketed and promoted for enhancing aspects of their hair or skin (e.g., Viviscal®, BioSil®, Nutrafol®, etc.) for the entire duration of the study andconfirms not using them one month prior to screening. This includes biotin-basedsupplements that provide 1000 micrograms or more biotin and/or contain biotin incombination with other ingredients promoted for hair and skin benefits.
• Individuals who agree to refrain from strenuous activity/exercise for at least 24hours prior to each study visit.
• Individuals who agree to refrain from alcohol-containing food or beverages for atleast 24 hours prior to each study visit.
• Individuals who agree to visit a 3rd party off-site laboratory and participate in ablood draw (N=40).
• Individuals who agree to avoid all tanning (sun or artificial such as tanning beds,sprays and other topical applications) and excessive sun exposure for the entireduration of the study and confirms avoiding these elements for 2 weeks prior toscreening.

Exclusion Criteria:

• Individuals who have had a history of any acute or chronic disease that couldinterfere with or increase the risk on study participation.
• Individuals with an active (flaring) disease or chronic skin allergies (atopicdermatitis, eczema, psoriasis, severe acne), or had recently treated skin cancer (within the last 12 months) or currently undergoing treatment for cancer.
• Individuals with a history of drug or alcohol abuse in the 12 months prior toscreening.
• Individuals with a history of immunosuppression/immune deficiency disorders orcurrently using immunosuppressive medications (e.g., azathioprine, belimumab,cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate,prednisone, Remicade, Stelara) and/or radiation as determined by study documentation.
• Individuals with damaged skin at or in close proximity to test sites (e.g., sunburn,tattoos, scars, excessive hair, or other disfigurations) that would impact studyassessments.
• Individuals having severe hair loss or are completely bald.
• Individuals with white or very light-colored hair that is not able to be analyzedusing the outlined instrumentation.
• Individuals who have any history, which, in the Investigator's opinion, indicates thepotential for harm to the subject or could place the validity of the study injeopardy.
• Individuals who have had any medical procedure, such as laser resurfacing,microdermabrasion, retinol or AHA treatments, hyaluronic injections, collagen, orchemical peels to the test sites within the last 6 months (including Botox, Restylyn,or other fillers).
• Individuals who are currently using or during the last 6 months have used, Retin A, orother Rx/OTC Retinyl A, or other astringent derived products or alpha hydroxyl acidtreatments for photo-aging and fine lines/wrinkles.
• Individuals who have used any products or devices to promote scalp hair growth (e.g.,finasteride, minoxidil, Rogaine, Propecia) within 6 months of screening; or refusal torefrain from any of these for the study duration.
• Individuals who have started, stopped, or changed hormone replacement therapy (HRT)within 6 months prior to screening.
• Subjects with history or presence of any clinically significant cardiovascular (lightheadedness/fainting or drops in blood pressure or recent myocardial infarction),respiratory (including uncontrolled asthma or allergies), renal, hepatic,gastrointestinal, hematologic, neurologic, any type of cancer that required radiationand/or chemotherapy for 1 year prior to study, metabolic disease or disorder,including guanidinoacetate methyltransferase deficiency and herpes (HSV-1), or anyuncontrolled medical illness which in the opinion of the Investigator would jeopardizethe safety of the subject, interfere with study assessments, or impact the validity ofthe study.
• Individuals who indicate that they are pregnant, planning a pregnancy or nursing.
• Individuals who have been medically diagnosed with Type I Diabetes.
• Individuals who have a known history of hypersensitivity to any cosmetics, personalcare products, and/or fragrances.
• Individuals who are employees of the company.