Efficacy and Tolerance Evaluation of an Amino Acid Food Supplement

NCT ID: NCT03801343

Last Updated: 2019-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-22
• Study Completion Date: 2018-12-21

Brief Summary

Skin moisturizing and elasticizing efficacy of an amino acid food supplement

Detailed Description

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.

Conditions

Skin Photoaging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nutrakos®

12 female subjects aged 35-70, have taken during a meal, for the 1 month ,2 stick packs/die of the food supplement

Group Type: EXPERIMENTAL

Nutrakos®

Intervention Type: 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.

Interventions

Nutrakos®

"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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Derming SRL

OTHER

Sponsor Role: lead

Responsible Party

Adele Sparavigna

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

DERMING

Milan, MI, Italy

Countries

Italy

Other Identifiers

E1618

Identifier Type: -

Identifier Source: org_study_id