Efficacy and Tolerance Evaluation of an Amino Acid Food Supplement

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

Skin moisturizing and elasticizing efficacy of an amino acid food supplement

Study Overview

• Status: Completed
• Conditions: Skin Photoaging
• Intervention / Treatment: Dietary supplement: Nutrakos®

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20159
      • DERMING

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrakos®; 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®; "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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Derming SRL

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2018
• Primary Completion (Actual): December 21, 2018
• Study Completion (Actual): December 21, 2018

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: E1618

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No