Efficacy and Safety of a Drinkable Nutraceutical for Hair Loss in Patients Using GLP-1/GIP Receptor Agonists

Olistic Research Labs S.L.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Telogen Effluvium

Interventions

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.

Eligibility

Sex: FEMALEMin age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. * Additional criteria to be included by the client. Exclusion Criteria: * 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. * Women with uncontrolled thyroid disorders (hyperthyroidism or hypothyroidism) within the 6 months prior to study initiation. * Women who have used anti-hair loss products within the last 3 months. * Women who have initiated or undergone dermatological treatment for hair loss within the last 6 months (minoxidil, finasteride, PRP, mesotherapy, etc.). * Women who have undergone hair transplantation within the 18 months prior to study initiation. * Women who have initiated treatment with anxiolytics, antidepressants, amphetamines, ACE inhibitors, or iron within the last 3 months. * Women who initiated or discontinued hormonal treatment (oral contraceptives, oral or topical hormone replacement therapy, ovarian stimulation) within the 3 months prior to study initiation. * Pregnant women, postpartum women (within 6 months), breastfeeding women, or women planning to become pregnant during the study period. * Additional exclusion criteria to be specified by the sponsor. * Any condition that, in the investigator's opinion, makes participation in the study inappropriate.

Outcomes

Primary Outcomes

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