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
|Condition or disease||Intervention/treatment||Phase|
|Skin Photoaging||Dietary Supplement: Nutrakos®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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)
- 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).
- 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.
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
|Milano, MI, Italy, 20159|