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Efficacy and Tolerance Evaluation of an Amino Acid Food Supplement

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ClinicalTrials.gov Identifier: NCT03801343
Recruitment Status : Completed
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Adele Sparavigna, Derming SRL

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

Condition or disease Intervention/treatment Phase
Skin Photoaging Dietary Supplement: Nutrakos® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerance Evaluation of "Nutrakos®" Amino Acid Food Supplement (Pilot Study)
Actual Study Start Date : November 22, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change from baseline of superficial skin hydration [ Time Frame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M) ]
    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.

  2. Change from baseline of deep skin hydration [ Time Frame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M) ]
    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)

  3. Change from baseline of skin plastoelasticity [ Time Frame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M) ]
    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).


Secondary Outcome Measures :
  1. Change from baseline of tolerance [ Time Frame: Basal visit (T0), 2 weeks (T2W), 1 month (T1M) ]
    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.



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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801343


Locations
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Italy
DERMING
Milano, MI, Italy, 20159
Sponsors and Collaborators
Derming SRL

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Responsible Party: Adele Sparavigna, Medical Doctor, Derming SRL
ClinicalTrials.gov Identifier: NCT03801343     History of Changes
Other Study ID Numbers: E1618
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No