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

NCT07484061 | Recruiting

• 1 other identifier: CT-ON-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Telogen Effluvium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (32)

• Hair loss

  From baseline to Day 180.

• Body composition

  From baseline to Day 180.

• Body composition

  From baseline to Day 180.

• Body composition

  From baseline to Day 180.

• Serum iron level

  From baseline to Day 180.

Other Outcomes (2)

• Self-assessment questionnaire

  From baseline to Day 180.

• Food consumption frequency questionnaire (PREDIMED questionnaire)

  From baseline to Day 180.

Study Arms (2)

Active Product Arm

EXPERIMENTAL

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.

Placebo Arm

PLACEBO COMPARATOR

Other: Placebo control

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. DIETARY_SUPPLEMENT

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.

Active Product Arm

Placebo control OTHER

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.

Placebo Arm

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Any condition that, in the investigator's opinion, makes participation in the study inappropriate.

Sponsors & Collaborators

• Grupo Dermatologico Y Estetico Pedro Jaen S.A.: collaborator
• Olistic Research Labs S.L.: lead

Study Sites (1)

Grupo Dermatologico Y Estetico Pedro Jaen S.A.

Madrid, Madrid, 28006, Spain

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Interventions

Minerals; Amino Acids; Plant Extracts

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Amino Acids, Peptides, and Proteins; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 19, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)