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

Official title

Evaluation of the Efficacy and Safety of a Drinkable Nutraceutical in Improving Hair Loss in Patients Treated With GLP-1/GIP Receptor Agonists: a Double-blind, 1:1 Randomized, Placebo-controlled Study.

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.

Interventions

• Dietary supplement 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.
  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.
• Other Placebo control
  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.

Primary outcome measures

• Hair loss [Time frame: From baseline to Day 180.]

Secondary outcome measures (12)

• Hair loss [Time frame: From baseline to Day 180.]
• Body composition [Time frame: From baseline to Day 180.]
• Body composition [Time frame: From baseline to Day 180.]
• Body composition [Time frame: From baseline to Day 180.]
• Serum iron level [Time frame: From baseline to Day 180.]
• Ferritin level [Time frame: From baseline to Day 180.]
• Transferrin level [Time frame: From baseline to Day 180.]
• Transferrin saturation [Time frame: From baseline to Day 180.]
• Serum zinc level [Time frame: From baseline to Day 180.]
• 25-hydroxyvitamin D level [Time frame: From baseline to Day 180.]
• Serum folate level [Time frame: From baseline to Day 180.]
• Vitamin B12 level [Time frame: From baseline to Day 180.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Spain · 1 center

• Grupo Dermatologico Y Estetico Pedro Jaen S.A. — Madrid

Publications

• Perera E, Sinclair R. Treatment of chronic telogen effluvium with oral minoxidil: A retrospective study. F1000Res. 2017 Sep 6;6:1650. doi: 10.12688/f1000research.11775.1. eCollection 2017. PMID 29167734

Identifiers

NCT: NCT07484061 · CT-ON-04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗