The purpose of this clinical trial is to evaluate the efficacy of Olistic© Next Women, a nutraceutical supplement, compared with placebo in improving hair loss in patients undergoing treatment with GLP-1/GIP agonists. This 6-month, randomized, placebo-controlled clinical study investigates whether daily supplementation with Olistic© Next Women leads to significant improvements in hair loss in this patient population. In addition, the study assesses the safety and tolerability of the product throughout the treatment period.
Female gender.
Age >35 years.
Initiation of treatment with a GLP-1/GIP agonist, or treatment duration < 3 months, as per routine clinical practice in the endocrinology clinic.
Having signed the participant information sheet and the written informed consent and having been informed of the objective of the study.
Allergy or hypersensitivity to any of the components of the product, or to a product from a similar category to the one being tested.
Scalp diseases: cicatricial alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate to severe seborrheic dermatitis, eczema, cancer, etc.
Women presenting alopecia due to an underlying medical condition (hypothyroidism, anemia, lupus, etc.).
Pharmacological treatment that may promote the onset of telogen effluvium, initiated within the 3 months prior to study start (e.g., valproic acid, carbamazepine, phenytoin, selective serotonin reuptake inhibitors, oral anticoagulants, retinoids, beta-blockers). Patients who have undergone a dose change of these medications within the same period are also excluded.
Parallel
Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +45.
Dietary supplementDrinkable 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.
Placebo control
Other interventionDrinkable 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.
Hair loss
• 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
Hair loss
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 composition
Body weight (Kg). Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor
Body composition
BMI (Kg/m2). Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor
Body composition
Fat mass and fat-free mass percentages. Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor
Self-assessment questionnaire
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.
Food consumption frequency questionnaire (PREDIMED questionnaire)
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.
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Olistic Research Labs S.L.
Lead sponsor
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Collaborator
