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

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.

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 Overview

• Status: Recruiting
• Conditions: Telogen Effluvium
• Intervention / Treatment: Other: Placebo control; 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28006
      • Recruiting
      • Grupo Dermatologico Y Estetico Pedro Jaen S.A.
      • Contact: Leyre Malet, PhD; Phone Number: +34 617862464; Email: info@icmrresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Arm	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.
Experimental: Active Product Arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From baseline to Day 180.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to Day 180.
Body composition	Body weight (Kg). Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor	From baseline to Day 180.
Body composition	BMI (Kg/m2). Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor	From baseline to Day 180.
Body composition	Fat mass and fat-free mass percentages. Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor	From baseline to Day 180.
Serum iron level	Serum iron concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Ferritin level	Serum ferritin concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Transferrin level	Serum transferrin concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Transferrin saturation	Transferrin saturation percentage calculated from iron metabolism parameters obtained from blood samples.	From baseline to Day 180.
Serum zinc level	Serum zinc concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
25-hydroxyvitamin D level	Serum 25-hydroxyvitamin D concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Serum folate level	Serum folate concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Vitamin B12 level	Serum vitamin B12 concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Serum albumin level	Serum albumin concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Thyroid-stimulating hormone (TSH) level	Serum thyroid-stimulating hormone concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Free thyroxine (free T4) level	Serum free thyroxine concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Total testosterone level	Serum total testosterone concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Free testosterone level	Serum free testosterone concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Dehydroepiandrosterone sulfate (DHEA-S) level	Serum dehydroepiandrosterone sulfate concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Sex hormone-binding globulin (SHBG) level	Serum sex hormone-binding globulin concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Fasting glucose level	Fasting blood glucose concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Glycated hemoglobin (HbA1c)	Glycated hemoglobin measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Fasting insulin level	Fasting serum insulin concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
HOMA-IR	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose and fasting insulin values.	From baseline to Day 180.
Total cholesterol level	Total cholesterol concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
HDL cholesterol level	HDL cholesterol concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
LDL cholesterol level	LDL cholesterol concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Triglyceride level	Serum triglyceride concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Aspartate aminotransferase (AST) level	AST concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Alanine aminotransferase (ALT) level	ALT concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Gamma-glutamyl transferase (GGT) level	GGT concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Blood urea level	Blood urea concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.
Serum creatinine level	Serum creatinine concentration measured in blood samples using standard clinical laboratory methods.	From baseline to Day 180.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to Day 180.
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.	From baseline to Day 180.

Collaborators and Investigators

• Sponsor: Olistic Research Labs S.L.
• Collaborators: Grupo Dermatologico Y Estetico Pedro Jaen S.A.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations; Inorganic Chemicals; Plant Preparations; Biological Products; Complex Mixtures; Amino Acids; Minerals; Plant Extracts
• Other Study ID Numbers: CT-ON-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No