Food supplement effect on ageing signs
| ISRCTN | ISRCTN54738427 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54738427 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Sponsor Code VCY24-009, proDERM Code 25.0008-23 |
| Sponsor | L'Oréal / CAI VICHY |
| Funder | L'Oréal / CAI VICHY |
- Submission date
- 03/11/2025
- Registration date
- 13/11/2025
- Last edited
- 12/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study is conducted to assess and compare whether two oral collagen food supplements can improve the appearance of skin aging signs, nails, body and hair. The principal criterion of the study is the firmness of the skin after 1 and 3 months of use. The results will be compared to a placebo.
Who can participate?
Healthy women between 45 and 65 years of age, with early signs of menopause or post-menopausal and with skin aging, specifically firmness and wrinkles.
What does the study involve?
This is a double blind, randomized and monocentric study. The Subjects will take one of the food supplements or the corresponding placebo once daily for 3 months. Skin measurements (firmness, wrinkles, elasticity, hydration ), hair (thickness), and nails (strength and thickness) will be taken at the beginning of the study, after 1 month, and after 3 months. Clinical evaluations by experts and instrumental assessments will be carried out. Participants will also fill in questionnaires and keep a daily log.
What are the possible benefits and risks of participating?
Possible Benefits: improvement of their skin aging, hair, and nails.
Possible Risks: side effects that can occur during the study will be monitored and recorded in a daily log.
Where is the study run from?
The sponsor of the study is Vichy Laboratoires, and SGS Proderm is the CRO center which runs the study in Germany.
When is the study starting and how long is it expected to run for?
Participation will take place between February 2025 to May 2025. The total treatment duration for each participant is 3 months.
Who is funding the study?
The study is funded by L'Oréal / CAI VICHY (France).
Who is the main contact?
1. Julie Faure, julie.faure@loreal.com
2. Claire Deloche-bensmaine, PhD, claire.deloche-bensmaine@loreal.com
2. Dr Polina Gulakova, Polina.Gulakova@sgs.com
Contact information
Principal investigator
Kiebitzweg 2
Schenefeld/Hamburg
22869
Germany
| Phone | +49 40 839 358 147 |
|---|---|
| katrin.unbereit@sgs.com |
Scientific
62, quai Charles Pasqua
Levallois
92300
France
| Phone | + 33 7 76 11 27 98 |
|---|---|
| claire.deloche-bensmaine@loreal.com |
Public
62, quai Charles Pasqua
Levallois
92300
France
| Phone | +33 6 88 26 55 27 |
|---|---|
| julie.faure@loreal.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | Single | |
| Purpose | Prevention | |
| Scientific title | Comparaison of 2 Nutricosmetics containing collagen on skin, body, hair and nail aging signs in women for 3 months | |
| Study objectives | The aim of this study is to investigate the cosmetic effect of two oral collagen food supplements on different skin ageing signs after 1 and 3 months of intake compared to their respective placebo groups. | |
| Ethics approval(s) |
Approved 29/01/2025, Institutional Review Board (Kiebitzweg 2, Schenefeld, D-22869, Germany; +49 (0)40 839358-0; IRB@proderm.de), ref: 2025/003 | |
| Health condition(s) or problem(s) studied | Healthy female subjects between 45 and 65 years of age, Fitzpatrick skin type I – III, with aging signs | |
| Intervention | Subjects take 3 food supplement tablets once daily for 3 months at home in the morning, drinking 1 cup of water during intake if necessary. In case intake was forgotten, the subjects shall not take the forgotten dose at another time. Then efficacy and safety assessments are carried out. • Active nutricosmetic A • Placebo nutricosmetic B • Active nutricosmetic C • Placebo nutricosmetic D Randomization process: The validated randomization function of secuTrial® will be used to assign the treatments A to D (1:1:1:1:1 ratio) employing an allocation procedure according to Pocock & Simon (Variance Minimization) to achieve the best possible balance regarding different strata e.g. STRATA 1 “age”, STRATA 2 “BMI”, STRATA 3 “menopausal status”, STRATA 4 “firmness score on cheeks” and STRATA 5 “protein intake”. The STRATA level for “age” will be 3 types: 45 – 50 years, 51 – 60 years and 61 – 65 years. The STRATA level for “BMI” will be 2 types: 20 – 25 kg/m2 and 26 – 30 kg/m2. The STRATA level for “menopausal status” will be 3 types: pre-menopausal, post-menopausal for 1 – 5 years and post-menopausal for 6 – 10 years. The STRATA “firmness score on cheeks” (assessment on day 0) will be 2 types: 3 – 4 and 5 – 6. The STRATA “protein intake” (sourced from meat, fish, egg, legumes, nuts, dairy products) will be 3 types: never to 3 times per week, 4 times per week to once a day and many times a day. 60 subjects will use one treatment: code A, B, C or D. A manual assignment of the last subjects to one of the treatment groups may be necessary to obtain equal numbers of subjects in each treatment group. | |
| Intervention type | Supplement | |
| Primary outcome measure(s) |
The skin firmness is measured using a Visual Analogue Scale (VAS) at baseline and after 1 and 3 months | |
| Key secondary outcome measure(s) |
The following secondary outcome measures were assessed at baseline and after 1 and 3 months: | |
| Completion date | 30/05/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 45 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target sample size at registration | 250 |
| Total final enrolment | 232 |
| Key inclusion criteria | 1. Written informed consent to participate in the study and to allow photo usage for illustrative and/or research purposes 2. Willingness to actively participate in the study and to come to the scheduled visits 3. Healthy subjects (according to investigator or designee) 4. Female 5. Caucasian 6. From 45 to 65 years of age 7. Menopausal* (from 1 year to 10 years) *Menopausal = women having at least 1 year without menstruation 8. Pre-menopausal with first symptoms of the menopause (e.g. hot flashes, irregular menstruation, intensity of menstruation flow, mood changes, myalgia, headaches, insomnia, etc) 9. BMI (body mass index) ≥ 20 and ≤ 30 kg/m2 10. Skin firmness ≥ 3 and ≤ 6 on the cheeks (on a 10 points scale) 11. Phototype I, II or III 12. Nail length of at least 4 mm 13. Hair length of at least 2 cm 14. Pre-menopausal females: using adequate contraception (implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomised partner, cosexual partner, condom) 15. Preferably subjects with no cigarette consumption or 1-2 cigarettes a week, if necessary smoker but with no increase of the cigarette consumption will be accepted to complete the panel 16. Preferably, subjects with no alcohol consumption or 1-2 glasses a week , if necessary subjects with no increase of the alcohol consumption will be accepted to complete the panel 17. Menopausal females: Preferably, subjects with no hormonal replacement therapy, if necessary subjects with no beginning or modification of hormonal replacement therapy will be accepted to complete the panel |
| Key exclusion criteria | Nutrition 1. Documented allergies to food supplements and/or ingredients, to eggs 2. Intake of own food supplements (including vitamins and minerals) or other active compounds which may have an effect on skin 2 months prior to the start of the study and throughout the entire course of the study (excluding food supplements provided during the study) 3. Modification of weight of more than 5 kg 2 months prior to the start of the study Habits and practices 1. Drug addicts, alcoholics 2. Application of self-tanning products on the test area 4 weeks prior to the start of the study and/or throughout the entire course of the study 3. Nail biting habit 4. Employee of the study site 5. Aesthetic procedures (such as chemical peeling, lasers, dermabrasions, injections, anti-ageing mask, hair implant etc ….) performed in beauty salon or in medical offices at the test areas to be measured / assessed that could influence the investigation for 6 months prior to the start of the study 6. Application of peeling products at home on the test area 4 weeks prior to the start of the study and/or throughout the entire course of the study 7. Application of depigmenting cosmetic products and / or retinol based-cosmetics (or derivative), vitamin C based-cosmetic (or derivative) or AHA based-cosmetic on the evaluation areas 4 weeks prior to the start of the study and/or throughout the entire course of the study 8. Excessive sun exposure (natural or artificial - thus/visibly tanned) on the concerned areas 4 weeks prior to the start of the study and/or throughout the entire course of the study 9. Anti-aging cosmetic products and/or cosmetic products claiming efficacy on the skin firmness and wrinkles on the evaluation areas 2 weeks prior to the start of the study and/or throughout the entire course of the study 10. Visit the sauna or hammam 2 weeks prior to the start of the study Hormonal status Pre-menopausal females: Planned start or modification of oestro-progestogen treatment during the course of the study Global condition and health 1. Pre-menopausal females: Pregnancy or lactation 2. AIDS, HIV-positive or infectious hepatitis 3. Conditions which exclude a participation or might influence the test reaction/evaluation 4. Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area 5. Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years 6. One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases 7. Insulin-dependent diabetes mellitus 8. Active skin disease on the head, hands, thigh and volar forearms like acute dermatitis, that requires actual topical medication on the test area and/or systemic drug treatment according to a physician 9. Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test areas to be measured / assessed that could influence the investigation 10. Epilepsy 11. Chronic gastrointestinal diseases 12. Application of a treatment (oral or topical) with tretinoin or isotretinoin or corticosteroid 8 weeks prior to the start of the study and/or throughout the entire course of the study 13. Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) throughout the entire course of the study 14. Systemic long-term therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study 15. Instructions for subjects |
| Date of first enrolment | 03/02/2025 |
| Date of final enrolment | 21/02/2025 |
Locations
Countries of recruitment
- Germany
Study participating centre
Schenefeld/Hamburg
22869
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
03/11/2025: Study's existence conformed by the Institutional Review Board, SGS proderm GmbH.
