Efficacy and Tolerance Evaluation of an Amino Acid Food S... | NCT03801343

NCT03801343

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nutrakos®	Experimental	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®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutrakos®	Dietary Supplement	"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.

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Eligibility Module

Eligibility Criteria

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.