Clinical Evaluation of a Nutraceutical Supplement (Olistic Women) for Hair Growth and Hair Loss in Human Volunteers

NCT07111312 | Completed

• 1 other identifier: CT-OW-02
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief Summary

Hair loss is a multifactorial and complex condition influenced by factors such as hormonal changes, vitamin and mineral deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress. This 6-month randomized, double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of a drinkable nutraceutical formulated with natural, high-quality, patented, and standardized ingredients designed to support hair health through multiple biological pathways. A total of 106 premenopausal women aged 18 to 40 years and diagnosed with telogen effluvium were randomized to receive either the nutraceutical (n = 53) or placebo (n = 53). The primary endpoint was the increase in hair density from baseline versus placebo. The secondary endpoint was the change in the anagen-to-catagen/telogen (A:C/T) ratio. These parameters were assessed using phototrichoscopy and phototrichogram via TrichoScan®. The study was approved by an ethics committee and conducted by two independent board-certified dermatologists at two study sites.

Conditions

Telogen Effluvium

Outcome Measures

Primary Outcomes (1)

• Increase in hair density

  From phototrichogram on the temporoparietal area of the scalp.

  From enrollment to the end of treatment at 180 days.

Secondary Outcomes (1)

• Change in the Anagen-to-Catagen/Telogen ratio

  From enrollment to the end of treatment at 180 days.

Study Arms (2)

Active Product Arm

ACTIVE COMPARATOR

Dietary Supplement: Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.

Placebo Arm

PLACEBO COMPARATOR

Other: Placebo control

Interventions

Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women. 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, plant extracts, amino acids, and other bioactive compounds designed to support hair growth and scalp health in women.

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: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-40 years
• Sex: female
• Telogen effluvium diagnosis with hair loss \> 100 hairs, confirmed using validated "modified wash test"
• Otherwise, healthy volunteers
• Refraining from systemic, topical, oral products with similar effects to the active product
• Signed informed consent
• Maintenance of daily cosmetic and dietary routine
• Availability to attend all visits
• Compliance with all protocol requirements

You may not qualify if:

• Previous use of active product
• Participation in similar studies or usage of anti-hair loss products within the last 3 months
• History of dermatological treatment (e.g. mesotherapy) and/or hair transplant
• Skin or scalp diseases (e.g. psoriasis, dermatitis, alopecias)
• Alopecia secondary to medical diseases (e.g. hypothyroidism, anemia)
• Ongoing treatment for or diagnosis of systemic disease
• Hormonal treatment (oral or topical contraceptives) within 6 months prior to study start
• Known allergy or intolerance, including to any of the ingredients of the active product
• Pregnancy, post-partum (6 months) or breastfeeding

Sponsors & Collaborators

• Olistic Research Labs S.L.: lead

Study Sites (2)

Zurko-CTC

Barcelona, Spain

Location

Clínica AB Derma

Madrid, Spain

Location

Related Publications (1)

• Bernardez C, Podlipnik S, Westgate GE, Paus R, Zamfir L, Grohmann D, Saez Moya M. Efficacy and Safety of a Drinkable Nutraceutical in Premenopausal Women with Telogen Effluvium: A 6-Month, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2026 Jan;16(1):521-534. doi: 10.1007/s13555-025-01585-x. Epub 2025 Nov 25.

  PMID: 41288927 DERIVED

MeSH Terms

Interventions

Minerals; Plant Extracts

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Design

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

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 8, 2025
• Study Start: October 10, 2023
• Primary Completion: May 10, 2024
• Study Completion: September 23, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

ES (2)