Clinical trial for the assessment of the efficacy of a food supplement in improving hair appearance

ISRCTN	ISRCTN12083119
DOI	https://doi.org/10.1186/ISRCTN12083119
Study code/study no.	H.E.HU.TE.NHL00.060.08.00_ IT0000145/26
Sponsor	Bios Line S.p.A.
Funder	Bios Line S.p.A.

Submission date: 14/07/2026
Registration date: 23/07/2026
Last edited: 14/07/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gloria Roveda
Principal investigator

Via Mons. Angelini, 21
San Martino Siccomario
27028
Italy

Phone	+39 (0)382 490286
Email	info@complifegroup.com

Dr Sabrina Ghirlanda
Public, Scientific

Corso San Maurizio, 25A
Biella
13900
Italy

Phone	+39 (0)382 25504
Email	sabrina.ghirlanda@complifegroup.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Efficacy
Scientific title	Randomized placebo-controlled clinical trial for the assessment of the efficacy of a food supplement in improving hair appearance
Study objectives	The study is aimed to assess the efficacy of a food supplement (tested in different concentrations) in improving hair conditions in particular improving hair strength and radiance and reducing hair breakage compared to a placebo product.
Ethics approval(s)	Approved 03/02/2026, International Ethics and Integrity Committee (IEIC) (Via Per Garbagnate 61, Lainate, 20045, Italy; +39 (0)3783037302; secretariat@ieicomittee.com), ref: IC0013 A
Health condition(s) or problem(s) studied	Thin, brittle hair that breaks easily
Intervention	The active intervention consisted of a food supplement containing L-cystine, vitamin C, ceramides, Cotinus coggygria bark extract, zinc, folic acid, and vitamin B12. The placebo consisted of a comparable excipient matrix but did not contain the active ingredients. A restricted randomization list was generated by an independent technician using the appropriate algorithm ("Wei’s urn") of the PASS 11 software (PASS, LLC, Kaysville, UT, USA) and stored in a secure location. The principal investigator or designated study personnel dispensed the study products according to the randomization list. A total of 66 participants were randomized in a 1:1:1 ratio to one of three treatment groups (22 participants per group): Group 1: 2 tablets per day of the active food supplement and 2 tablets per day of placebo food supplement (for a total of 4 tablets per day) Group 2: 4 tablets per day of the active food supplement Group 3: 4 tablets per day of the placebo food supplement The study was conducted using a double-blind design, whereby participants, the principal investigator, and all study personnel involved in the conduct and assessment of the trial remained blinded to treatment allocation throughout the study. Participants received the assigned treatment for 84 ± 2 days.
Intervention type	Supplement
Primary outcome measure(s)	60-seconds hair count measured using a standardized brushing procedure (hair combing) at baseline and after 28 days and 84 days of treatment Hair elasticity (hair elongation) measured using a dynamometer (C610 Autotensile Tester, Labthink) at baseline and after 28 days and 84 days of treatment Hair radiance measured using a spectrophotometer/colorimeter CM 700D (Konica Minolta) at baseline and after 28 days and 84 days of treatment Overall hair appearance measured using expert scoring at 28 days and 84 days of treatment
Key secondary outcome measure(s)	Efficacy perceived and the pleasantness of the product measured using a self-evaluation questionnaire at the end of the study (84 days)
Completion date	18/06/2026

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	62 Years
Sex	Female
Target sample size at registration	66
Total final enrolment	66
Key inclusion criteria	1. Good general health 2. Caucasian ethnicity 3. Female sex 4. Age between 18 and 60 (+2) years old 5. Thin, brittle hair that breaks easily 6. Agree to not to take any treatment (oral or topic) able to interfere with the hair strength during the whole study duration 7. Willingness not to dye/blench hair during the 2 weeks preceding each visit 8. Willingness not to cut hair for the entire study length 9. Registered with health social security or health social insurance 10. Signed their written Informed Consent form (ICF) and Privacy Policy for their participation in the study and a photograph authorization 11. Able to understand the language used in the investigation centre and the information given 12. Able to comply with the protocol and follow protocol constraints and specific requirements 13. Willingness to take during the entire study period only the product to be tested 14. Willingness not to use/take similar products/food supplement that could interfere with the product to be tested 15. Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet, etc) 16. Under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial
Key exclusion criteria	1. Do not meet the inclusion criteria 2. Taking part or planning to participate to another clinical study in the same or in another investigation centre 3. Deprived of freedom by administrative or legal decision or under guardianship 4. Admitted to a sanitary or social facilities 5. Planning a hospitalization during the study 6. Under treatment with food supplements which could interfere with the functionality of the product under study 7. Participated in another clinical study with anti-hair loss product or treatment within the last 24 weeks before the inclusion visit 8. Breastfeeding or pregnant or not willing to take necessary precautions to avoid pregnancy during the study (if women of childbearing potential) 9. Has started or changed oestrogen-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study 10. Having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 11. Under radiotherapy or chemotherapy at any time 12. Under locally pharmacological/non-pharmacological treatment applied on the area of interest monitored during the test 13. Eating disorders 14. Any other hair disorder or hair disease (female-pattern hair loss, any type of alopecia) 15. Excessive and/or fluctuating hair shedding for more than 6 months 16. History or clinical signs of hyperandrogenaemia 17. Any hair care product applied on the scalp between the last shampoo and the inclusion visit (e.g., gel, hairspray, wax, foam) 18. Scalp surgery (hair transplants, laser) at any time
Date of first enrolment	03/03/2026
Date of final enrolment	13/03/2026

Locations

Countries of recruitment

Italy
Spain

Study participating centres

Complife Italia S.r.l.

Via Monsignor Angelini, 21
San Martino Siccomario
27028
Italy

Complife Italia S.r.l.

Corso San Maurizio, 25
Biella
13900
Italy

Complife Italia S.r.l.

Via Signorelli, 159
Garbagnate Milanese
20024
Italy

Complife Italia S.r.l.

Piazzale Siena, 11
Milano
20146
Italy

Nutratech S.r.l.

Via Francesco Todaro, 20/22
Rende
87036
Italy

Complife Iberia S.r.l.

Capitán Arenas 3 local 3
Barcelona
08034
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version 1	29/01/2026	14/07/2026	No	No

Additional files

49912_PROTOCOL_29Jan2026.pdf: Protocol file

Editorial Notes

14/07/2026: Study's existence confirmed by the International Ethics and Integrity Committee (IEIC).