Skuteczność i bezpieczeństwo napoju nutraceutycznego na wypadanie włosów u pacjentów stosujących agonistów receptorów GLP-1/GIP

Drinkable formulation consisting of an excipient formulation designed to mimic the organoleptic properties of the active product, reproducing its color and texture while achieving a highly similar taste profile.

Drinkable multifactorial food supplement in liquid form, administered once daily in a 25 mL single-dose vial, for a duration of 180 days. The formulation contains a combination of vitamins, minerals, amino acids, plant extracts, and other bioactive compounds designed to support hair growth and scalp health in women +45.

• Patient Reported Outcome using the Hair Shedding Scale: will assess the degree of hair loss among participants. On the day of the visit, they will be shown an A4 sheet with six ranges: between 1 (minimal shedding) to 6 (copious hair shedding).

Ref. Perera E and Sinclair R, 2017

Comb and Wash Test: this test will quantify the number of fallen hairs (outcome number of shed hairs). It will be carried out after refraining from washing the hair for 48 hours and combing the hair for 24 hours.

Body weight (Kg). Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor

BMI (Kg/m2). Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor

Fat mass and fat-free mass percentages. Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor

Serum iron concentration measured in blood samples using standard clinical laboratory methods.

Serum ferritin concentration measured in blood samples using standard clinical laboratory methods.

Serum transferrin concentration measured in blood samples using standard clinical laboratory methods.

Transferrin saturation percentage calculated from iron metabolism parameters obtained from blood samples.

Serum zinc concentration measured in blood samples using standard clinical laboratory methods.

Serum 25-hydroxyvitamin D concentration measured in blood samples using standard clinical laboratory methods.

Serum folate concentration measured in blood samples using standard clinical laboratory methods.

Serum vitamin B12 concentration measured in blood samples using standard clinical laboratory methods.

Serum albumin concentration measured in blood samples using standard clinical laboratory methods.

Serum thyroid-stimulating hormone concentration measured in blood samples using standard clinical laboratory methods.

Serum free thyroxine concentration measured in blood samples using standard clinical laboratory methods.

Serum total testosterone concentration measured in blood samples using standard clinical laboratory methods.

Serum free testosterone concentration measured in blood samples using standard clinical laboratory methods.

Serum dehydroepiandrosterone sulfate concentration measured in blood samples using standard clinical laboratory methods.

Serum sex hormone-binding globulin concentration measured in blood samples using standard clinical laboratory methods.

Fasting blood glucose concentration measured in blood samples using standard clinical laboratory methods.

Glycated hemoglobin measured in blood samples using standard clinical laboratory methods.

Fasting serum insulin concentration measured in blood samples using standard clinical laboratory methods.

Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose and fasting insulin values.

Total cholesterol concentration measured in blood samples using standard clinical laboratory methods.

HDL cholesterol concentration measured in blood samples using standard clinical laboratory methods.

LDL cholesterol concentration measured in blood samples using standard clinical laboratory methods.

Serum triglyceride concentration measured in blood samples using standard clinical laboratory methods.

AST concentration measured in blood samples using standard clinical laboratory methods.

ALT concentration measured in blood samples using standard clinical laboratory methods.

GGT concentration measured in blood samples using standard clinical laboratory methods.

Blood urea concentration measured in blood samples using standard clinical laboratory methods.

Serum creatinine concentration measured in blood samples using standard clinical laboratory methods.

Subject-reported perception of hair condition assessed using a 12-item questionnaire covering perceived hair density, hair shedding, hair strength, hair volume, appearance, and scalp condition. Each item is rated on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree." Higher scores indicate greater perceived improvement in hair and scalp condition.

Adherence to the Mediterranean diet assessed using the validated 14-item PREDIMED (Prevención con Dieta Mediterránea) questionnaire. The questionnaire evaluates the frequency of consumption of key food groups and dietary habits characteristic of the Mediterranean diet, including olive oil use, fruit and vegetable intake, legumes, fish, nuts, red meat, sugary beverages, commercial pastries, and wine consumption. Each item is scored 0 or 1, resulting in a total score ranging from 0 to 14, with higher scores indicating greater adherence to the Mediterranean diet.