Clinical study to assess the efficacy of a food supplement for hair care

ISRCTN	ISRCTN81317148
DOI	https://doi.org/10.1186/ISRCTN81317148
Protocol serial number	H.E.HU.AL.NHL00.132.01.00_IT0005615/25
Sponsor	EVRA S.r.L.
Funder	EVRA S.r.L.

Submission date: 21/11/2025
Registration date: 24/11/2025
Last edited: 24/11/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Healthy and strong hair is an important aspect of well-being and self-confidence. However, factors such as stress, diet, aging, and oxidative stress can negatively affect hair growth and quality. EVRA S.r.L., the sponsor of this study, is interested in testing a food supplement designed to improve overall hair condition, including structure, shine, and growth. The product contains Annurtrofil, an extract obtained from the Annurca apple (Malus pumila Mill. cv Annurca), a special variety traditionally ripened on straw beds after harvest. This process increases its content of polyphenols, vitamin B2, and chlorogenic acid, which are known for their antioxidant and protective effects.

Research suggests that Annurtrofil can help protect hair and skin cells from oxidative stress, improve scalp microcirculation, and stimulate the natural production of keratin, the main structural protein of hair. Clinical studies have already shown that Annurtrofil is safe and may promote hair growth and quality when taken at a daily dose of 800 mg. The aim of this new clinical study is to confirm these beneficial effects and to test whether a lower dose (400 mg/day) is also effective and well tolerated. Testing a lower dosage could make the supplement more accessible and easier to use, while providing new scientific data to support its role in hair health. The study design will help to understand the dose–response relationship and confirm the efficacy and safety of the product in improving hair condition.

Who can participate?
Healthy women and men aged between 18 and 60 years who have mild to moderate damaged hair and hair shine ranging from luster-less to lustrous.

What does the study involve?
Participants will give their written informed consent before starting the study. Participants will then be randomly assigned to three groups:
One group taking Annurtrofil 800 mg/day
One group taking Annurtrofil 400 mg/day
One group taking a placebo (a capsule with no active ingredients)

During the study, participants will take two capsules per day. The study will last 6 months (168 days ± 2 days) and will include five visits: an initial screening, a baseline visit, and follow-up visits after 56, 112, and 168 days. During the visits, the Principal Investigator or designated personnel will verify participants’ eligibility and perform several hair and scalp assessments, including: measurement of hair gloss and shine, phototrichogram analysis for hair growth, evaluation of overall scalp condition, and collection of hair samples to assess elasticity, structure, and keratin content.
At follow-up visits, participants will also be asked to complete a self-assessment questionnaire. Additionally, blood tests will be performed before starting the product and after 168 days of treatment to assess tolerability.

What are the possible benefits and risks of participating?
The possible benefits include an improvement in overall hair condition, such as better structure, shine, and growth. The food supplement tested in this study complies with current food regulations and contains ingredients that are known to be safe for human use.
No side effects are expected when used as directed. However, as with any food product, there is a small chance of individual reactions. Before taking part, participants will be informed if the product contains any substances that could cause allergies or sensitivities.

Where is the study run from?
Study sites:
Complife Italia S.r.l., Italy

When is the study starting and how long is it expected to run for?
November 2025 to September 2026

Who is funding the study?
EVRA S.r.L., Italy

Who is the main contact?
Roberta Villa, roberta.villa@complifegroup.com

Contact information

Dr Enza Cestone
Principal investigator

Via Guido Rossa, 1
Garbagnate Milanese (MI)
20024
Italy

Phone	+39038225504
Email	info@complifegroup.com

Dr Roberta Villa
Public, Scientific

Viale Indipendenza, 11
Pavia (PV)
27100
Italy

Phone	+39038225504
Email	roberta.villa@complifegroup.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Treatment
Scientific title	Clinical instrumental evaluation of the efficacy of a food supplement for hair care: a randomized, double-blind, placebo-controlled study
Study acronym	HAIRSUP
Study objectives	The primary objective of this study is to evaluate the efficacy of the product in improving hair structure, shine, and growth. The secondary objective of this study is to evaluate the efficacy and pleasantness of the product as perceived by the subjects, improvements in overall scalp condition, and the safety of use.
Ethics approval(s)	Approved 14/11/2025, International Ethics and Integrity Committee (Via Per Garbagnate 61, Lainate (MI), 20020, Italy; +393497592449; secretariat@ieicommittee.com), ref: IC002A
Health condition(s) or problem(s) studied	Healthy female and male subjects with mild to moderate damaged hair and with hair shine ranging from luster-less to lustrous
Intervention	The product under investigation is a food supplement that includes Annurca apple fruit dry extract. Participants will be randomly assigned, in equal proportions (1:1:1), to one of three treatment groups. One third of the subjects (Group 1) will receive the active product at the higher dose (two capsules of 400 mg each, for a total daily dose of 800 mg/day). Another third (Group 2) will receive the active product at the lower dose (one 400 mg active capsule and one placebo capsule, for a total daily dose of 400 mg/day). The remaining third (Group 3) will receive two placebo capsules per day. A restricted randomization list will be 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. In order to ensure a balanced allocation by sex, the randomization will be stratified so that male and female participants are equally distributed among the low-dose active group, the high-dose active group, and the placebo group. The Principal Investigator or designated personnel will dispense the products according to the generated randomization list. The study is conducted as a double-blind trial: subjects, investigators, and collaborators are blinded to product allocation. All participants will take the assigned treatment once daily, for a total duration of 168 ± 2 days, as follows: Group 1: subjects will take two capsules of the active product once daily, in the morning on an empty stomach. Group 2: subjects will take one capsule of the active product and one capsule of the placebo once daily, in the morning on an empty stomach. Group 3: subjects will take two capsules of the placebo once daily, in the morning on an empty stomach.
Intervention type	Supplement
Primary outcome measure(s)	1. Hair gloss (arbitrary units) measured using a spectrophotometer/colorimeter CM 700D (Konica Minolta) (the 8° gloss parameter is measured) at baseline and 56, 112 and 168 days of treatment 2. Hair density (number/cm2) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 3. Anagen hair density (number/cm2) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 4. Telogen hair density (number/cm2) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 5. Anagen hair (%) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 6. Telogen hair (%) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 7. Anagen/telogen ratio measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 8. Hair vellus density (number/cm2) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 9. Terminal hair density (number/cm2) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 10. Hair thickness (μm) measured using a phototrichogram at baseline and 56, 112 and 168 days of treatment 11. Hair elasticity (%) measured using a dynamometer (C610 Autotensile Tester, LabThink) at baseline and 56, 112 and 168 days of treatment 12. Hair shine visually evaluated by the Principal Investigator and/or designated qualified personnel using a 5-point scale at baseline and 56, 112 and 168 days of treatment 13. Hair structure visually evaluated by the Principal Investigator and/or designated qualified personnel on Scanning Electron Microscopy (SEM) images using a 12-point scale at baseline and 56, 112 and 168 days of treatment 14. Keratin content (µg/mL) measured through in vitro analysis performed on collected hair samples at baseline and 56, 112 and 168 days of treatment
Key secondary outcome measure(s)	1. Overall scalp condition visually evaluated by the Principal Investigator and/or designated qualified personnel by observing scalp images captured with a dermatoscope and rated using a 7-point Likert scale at baseline and 56, 112 and 168 days of treatment 2. Self-assessment using a self-evaluation questionnaire (multiple choice questions/numerical rating scale from 1 to 10) 56, 112 and 168 days after treatment 3. Complete blood count (red blood cells, leukocyte count, hemoglobin, hematocrit, platelets) measured using standard medical laboratory methods at baseline, and after 168 days of treatment 4. Lactate dehydrogenase (LDH) measured using standard medical laboratory methods at baseline, and after 168 days of treatment 5. GOT transaminase (AST) measured using standard medical laboratory methods at baseline, and after 168 days of treatment 6. GPT transaminase (ALT) measured using standard medical laboratory methods at baseline, and after 168 days of treatment 7. Alkaline phosphatase measured using standard medical laboratory methods at baseline, and after 168 days of treatment 8. Creatinine measured using standard medical laboratory methods at baseline, and after 168 days of treatment 9. Total cholesterol measured using standard medical laboratory methods at baseline, and after 168 days of treatment 10. HDL cholesterol measured using standard medical laboratory methods at baseline, and after 168 days of treatment 11. LDL cholesterol measured using standard medical laboratory methods at baseline, and after 168 days of treatment 12. Triglycerides measured using standard medical laboratory methods at baseline, and after 168 days of treatment 13. Fasting glucose measured using standard medical laboratory methods at baseline, and after 168 days of treatment 14. TSH reflex measured using standard medical laboratory methods at baseline, and after 168 days of treatment 15. Prothrombin time (PT) measured using standard medical laboratory methods at baseline, and after 168 days of treatment 16. Activated partial thromboplastin time (APTT) measured using standard medical laboratory methods at baseline, and after 168 days of treatment
Completion date	30/09/2026

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	132
Key inclusion criteria	1. Healthy female and male subjects (50% per gender in each group) 2. Subjects of Caucasian ethnicity 3. Subjects aged between 18 and 60 years (extremes included) 4. Subjects with mild to moderate damaged hair (Total hair damage score based on exposure to risk factors <18). Hair damage is evaluated using a scoring system based on the frequency of exposure to specific damaging practices and environmental factors. Each behaviour is assigned a point value according to its frequency of occurrence . The total score is then used to classify the extent of hair damage: Less than 7: Mild damage; 7 to 18: Moderate damage; 18 or more: Severe damage. 5. Subjects with hair shine ranging from luster-less to lustrous (scores 1–3 on the 5-point Visual Shine Scale). Visual evaluation is performed by the Principal Investigator or designated qualified personnel using a 5-point scale, as follows: 1 = Luster-less (little to no shine) 2 = Somewhat luster-less (slightly lacking shine) 3 = In-between (normal shine) 4 = Somewhat lustrous (slightly shiny) 5 = Lustrous (very shiny) 6. Subjects who commit to refraining from the use of any specialized hair products or topical depilatory agents throughout the study 7. Subjects who commit to not manipulating their hair, while maintaining their usual hairstyle during the study 8. Subjects who commit to using a neutral shampoo during the 2-week washout period prior to the experimental phase and throughout the entire study 9. Subjects registered with National Health Service (NHS) 10. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel 11. Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel 12. Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements 13. Subjects who commit not to change the daily routine and lifestyle during the study 14. Stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study 15. Subjects informed about the test procedures who have signed a consent form and privacy agreement
Key exclusion criteria	1. Subjects who do not meet the inclusion criteria 2. Subjects with scalp or hair diseases (e.g.: scalp psoriasis, eczema, and seborrheic dermatitis) or other causes of hair loss, including androgenetic alopecia, alopecia areata, or other clinically significant alopecia conditions 3. Subjects who are taking oral contraceptives 4. Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study: 4.1. AST or ALT> 2 × unl (upper normal limit) 4.2. Hepatitis, liver cirrhosis, fatty liver requiring treatment 4.3. Serum creatinine > 2 × unl, chronic renal failure, kidney disease requiring dialysis 4.4. Hypertension 4.5. Diabetes mellitus 4.6. Known malignancy within the past 5 years 4.7. Clinically relevant psychiatric conditions 4.8. Infectious skin conditions 4.9. Autoimmune diseases 5. Subjects participating or planning to participate in other clinical trials 6. Subjects who participated in a similar study without respecting an adequate washout period (at least three month) 7. Subjects that have food intolerances or food allergies to ingredients of the study product 8. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator: 8.1. Use of topical hair growth agents within the past month 8.2. Application of steroid preparations to the scalp within the past month 8.3. Use of any of the following drugs within the past month: steroids, cytostatics, vasodilators, antihypertensives, anticonvulsants, beta-receptor blockers, bronchodilators, diuretics, spironolactone, cimetidine, diazoxide, cyclosporine, ketoconazole, or other agents known to affect hair growth 8.4. Use of oral antiandrogens (e.g., dutasteride, finasteride) within the last 6 months 8.5. Use of any medication known to interfere with hair growth within the past 3 months 8.6. Use of chemotherapeutic 8.7. Use of biologic medicines 9. Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least three month) 10. Subjects admitted to a health or social facility 11. Subjects planning a hospitalization during the study 12. Subjects not able to be contacted in case of emergency 13. Subjects deprived of freedom by administrative or legal decision or under guardianship 14. Subjects who have or have had a history of alcohol or drug addiction 15. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.) 16. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
Date of first enrolment	14/11/2025
Date of final enrolment	21/01/2026

Locations

Countries of recruitment

Italy

Study participating centres

Complife Italia S.r.l.

Via Monsignor Angelini, 21
San Martino Siccomario (PV)
27028
Italy

Complife Italia S.r.l.

Corso San Maurizio, 25
Biella
13900
Italy

Complife Italia S.r.l.

Via Signorelli, 159
Garbagnate Milanese (MI)
20024
Italy

Complife Italia S.r.l.

Piazzale Siena, 11
Milano (MI)
20146
Italy

Complife Italia S.r.l.

Via Mortara, 171
Ferrara (FE)
44121
Italy

Nutratech S.r.l.

Via Francesco Todaro, 20/22
Rende (CS)
87036
Italy

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication, Stored in non-publicly available repository
IPD sharing plan	Stored in non-publicly available repository. Published as a supplement to the results publication.

Editorial Notes

24/11/2025: Study's existence confirmed by the International Ethics and Integrity Committee.