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

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.

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Key information

Conditions

Telogen Effluvium

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zurko-CTC, Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

Increase in hair density

Time frame: From enrollment to the end of treatment at 180 days.

From phototrichogram on the temporoparietal area of the scalp.

Secondary outcomes

Change in the Anagen-to-Catagen/Telogen ratio

Time frame: From enrollment to the end of treatment at 180 days.

From phototrichogram on the temporoparietal area of the scalp.

Sponsors and collaborators

Lead sponsor

Olistic Research Labs S.L.

Industry

Registry information

Official study title

Placebo-controlled, Parallel, Randomized (1:1), Double-blind Study Over 6 Months to Evaluate the Efficacy and Safety of the Food Supplement Olistic Women.

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Aug 8, 2025
Registry last updated: Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed