Efficacy and Tolerance Evaluation of an Amino Acid Food Supplement

Study Overview
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Brief Summary
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Skin moisturizing and elasticizing efficacy of an amino acid food supplement

Detailed Description
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Primary end point of this study was to evaluate the moisturizing and elasticizing activity of Nutrakos® Amino Acid Food Supplement, both photoexposed and not photoexposed on skin areas (forearm volar and dorsal surface) by non-invasive instrumental measurements; the product will be tested for 1 month by female subjects, aged 35-70 years with skin photoaging. An additional aim of this study was to evaluate the product tolerance both by investigator and volunteers.

Official Title
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Efficacy and Tolerance Evaluation of Nutrakos® Amino Acid Food Supplement (Pilot Study)

Conditions
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Skin Photoaging

Intervention / Treatment
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* Dietary Supplement: Nutrakos®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female sex, 35-70 years, skin phototype II and III according to Fitzpatrick's classification (see par. 8.2.1) accepting to not change their habits regarding food, physical activity, body cosmetic and cleansing products; accepting not to expose their body to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study; accepting to sign the informed consent form. Exclusion Criteria: Pregnancy; lactation; smokers; alcohol or drug abusers; skin phototype I, IV, V and VI according to Fitzpatrick's classification subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study; subjects not in menopause who do not accept to perform the pregnancy test at T0 and at the end of the study (T1M); Body Mass Index (BMI) variation (± 1) during the study period; change in the normal habits regarding food, physical activity, body cosmetic and cleansing use during the month preceding the test; sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit); subjects whose insufficient adhesion to the study protocol is foreseeable; participation in a similar study currently or during the previous 6 months; dermatitis; presence of cutaneous disease on the tested area, as lesions, scars, malformations; clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne); diabetes; endocrine disease; hepatic disorder; renal disorder; cardiac disorder; pulmonary disease; cancer; neurological or psychological disease; inflammatory/immunosuppressive disease; drug allergy; anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year before the study); using of drugs able to influence the test results in the investigator opinion.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrakos®<br>12 female subjects aged 35-70, have taken during a meal, for the 1 month ,2 stick packs/die of the food supplement | Dietary Supplement: Nutrakos®<br>* Nutrakos® Amino Acid Food Supplement supplies a specific mixture of amino acids that has been proven to induce synthesis of collagen and elastin, the main proteins of derma structure in fibroblasts and keratocytes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of superficial skin hydration | Skin electrical capacitance value was measured mono-laterally on the right or left forearm (volar and dorsal surface) with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level. | Basal visit (T0), 2 weeks (T2W), 1 month (T1M) | 
| Change from baseline of deep skin hydration | Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the right or left forearm (volar and dorsal surface) with MoistureMeterD (Delfin Technologies, Kuopio - Finland) | Basal visit (T0), 2 weeks (T2W), 1 month (T1M) | 
| Change from baseline of skin plastoelasticity | Superficial and deep skin plastoelasticity were measured mono-laterally on the right or left forearm (volar and dorsal surface) with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK). | Basal visit (T0), 2 weeks (T2W), 1 month (T1M) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of tolerance | The food supplement tolerance was evaluated considering: any adverse event related to the study treatment, which occurred during the study; any judgement reported by the volunteers. | Basal visit (T0), 2 weeks (T2W), 1 month (T1M) |