Clinical Study to Evaluate the Impact of Nutraceutical Supplements in Participants With Self-Perceived Thinning Hair

• Males and females of Fitzpatrick skin types I-V, and all hair types between 20-65 years of age with self-perceived thinning, confirmed by a dermatologist.
• Study population will be approximately 50% men and 50% women.
• Clinically confirmed to have hair thinning or loss by the investigator or qualified sub-investigator or qualified grader via physical exam, including only male participants with pattern hair loss with frontal and/or vertex patterns II, IIA, III, IIIv and IV using the Norwood classification of patterned hair loss in males or female participants with hair late patterns I-2, I-3, or I-4 on the Savin scale.
• Willing and able to adhere to the same dietary lifestyles, including not introducing new supplements or vitamins, for the duration of the study.
• Able to understand and sign an informed consent agreement and photo release form approved by the Institutional Review Board.
• General good health, as determined by the Investigator or qualified sub investigator.
• Willing and able to attend all study visits and comply with the test product daily instructions.
• Willing to use a mild non-medicated shampoo and conditioner for the duration of the study (medicated shampoo and conditioner refer to any prescription shampoo or conditioner as well as any over-the counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth).
• Willing to remove any twists, braids, cornrows, hair extensions prior to study visits.
• Willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

• Individuals who are pregnant, planning a pregnancy, nursing, or within 1year post-partum.
• Clinical diagnosis of hair loss disorder such as alopecia areata, or scarring forms of alopecia.
• Individuals who have had a history of any acute or chronic disease that could interfere with or increase the risk of study participation.
• Individuals with a BMI\<18 or BMI > 33.
• Individuals who have had a history of any acute or chronic medical or hair condition that could affect study results, such as a history of disordered eating.
• Scalp hair loss on the treatment area, due to disease, injury, or medical therapy.
• Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), infection, cuts, and/or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator or qualified sub-investigator, might put the participant at risk or interfere with the study conduct or evaluations.
• History of surgical correction of hair loss on the scalp (i.e., hair transplant).
• Use of any chemical to treat your hair (including but not limited to hair coloring, bleaching, chemical straightening or relaxers) during the study.
• Use of any anti-inflammatory (except 81mg baby Aspirin), immunosuppressant during the study.Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 6 months prior to the Baseline Visit.
• Use of incretin-based therapy, such as a GLP-1 receptor agonist, within the 6 months prior to screening.
• Females who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study (the initiation of HRT or birth control should not have been associated with the initiation of hair loss/thinning).
• Men currently using, planning to use, or have used anabolic-androgenic steroids (testosterones). Men currently undergoing hormone/testosterone replacement therapy [TRT] can be eligible for the study if they have maintained a stable dose for at least 6 months prior to enrollment and stay on the same dose throughout the study.
• Any participant who is using anti-androgen medication (such as spironolactone, flutamide, cyproterone acetate, cimetidine) other than oral contraceptives; platelet-rich plasma (PRP) injections; or tamoxifen within 3 months of study start.
• History of malignancy (except cutaneous squamous cell carcinoma and basal cell carcinoma) or currently undergoing chemotherapy or radiation treatments.
• A known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders that in the opinion of the Investigator or qualified sub-investigator may interfere with the study treatment.
• A known history of unstable or chronic depression or bipolar disease or any other condition that may impact the participant's participation in the opinion of the investigator or qualified sub-investigator.
• A known allergy to any of the ingredients in the investigational product.
• Utilization of low-level lasers for hair growth in the last three months.
• Any condition that the Investigator thinks may put the participant at risk or interfere with their participation in the study or study results.
• Known history of or current iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as participants receiving anticoagulant therapy.
• Use of any supplements, products, medications, or medicated shampoos that are known to potentially cause hair loss or affect hair growth, including but not limited to, ashwagandha, turmeric, and saw palmetto, as determined by the Investigator or qualified sub-investigator.
• Affiliations with the testing facility or sponsor.