Efficacy and Tolerance Evaluation of an Anti-age Food Supplement

Study Overview
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Brief Summary
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Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled Clinical Study Versus Untreated Group

Detailed Description
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Aim of the study was to evaluate the anti-age activity of Pre-Hyaluron 465 Innēov a food supplement, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese), taken for 4 consecutive months by female subjects aged 35-60 years (with preference for subjects over 45 years), with moderate-severe skin aging/photoaging according to a reference photographic scale. The study foresaw the evaluation of the study product activity versus a control group, untreated.

Official Title
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Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled Clinical Study Versus Untreated Group

Conditions
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Moderate-severe Skin Aging/Photoaging

Intervention / Treatment
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* Dietary Supplement: Pre-Hyaluron 465 Innēov


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female sex, age 35-60 years (with preference for subjects over 45 years), body mass index (BMI) 18-27, caucasian healthy subjects with moderate-severe cutaneous aging/photoaging (score > 3 of the reference photographic scale in appendix 8), agreeing to present at each study visit without make-up, accepting to follow the instructions received by the investigator, accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products, agreeing not to apply any topical or take any oral product or nutritional supplementation (vitamins and minerals) other than the investigational products, or use face massages or other means known to improve skin wrinkles or skin qualities during the entire duration of the study, accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study, no participation in a similar study actually or during the previous 3 months accepting to sign the Informed consent form. Exclusion Criteria: Pregnancy, lactation, 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, T1, T2 and T3, 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. 4.4.2. Dependent on a clinical condition 4.4.2.1. Dermatological disease, Presence of cutaneous disease on the tested area as lesions, scars, malformations, recurrent facial/labial herpes, clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.). 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 (application on the face) and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of hormonal treatment starting more than 1 year ago), assumption of drugs or dietary supplements able to influence the test results in the investigator opinion.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-Hyaluron 465 Innēov<br>43 caucasian female subjects have taken during a meal, for the first 4 months of trial,1 capsule and 1 tablet/die of the food supplement composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese) . | Dietary Supplement: Pre-Hyaluron 465 Innēov<br>* Food supplement consisting og a tablet and a capsule, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese)<br>|
| No Intervention: Untreated group<br>23 caucasian female subjects untreated | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crow's feet visual score variation | Wrinkles grade was determined according to l'Oreal clinical standardized photographic scales | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 
| Nasolabial folds visual score variation | Wrinkles grade was determined according to l'Oreal clinical standardized photographic scales | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 
| Surface microrelief regularity evaluation | Regularity grade was evaluated according to this score: = very regular = regular = irregular = very irregular | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 
| Skin resistance to pinching clinical score variation | The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important = important = moderate = weak = very weak | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 
| Skin resistance to traction clinical score variation | The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important = important = moderate = weak = very weak | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 
| Skin recovery after pinching clinical score variation | The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important = important = moderate = weak = very weak | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 
| Skin dryness clinical score variation | Clinical evaluation of skin dryness was performed according to the following score: 0 = very hydrated skin = hydrated skin = normal skin = kindly dry skin = dry skin = very dry skin | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 
| Vascular homogeneity clinical score variation | Homogeneity grade was determined according to specific reference clinical and photographic scales and to the following clinical score: 0 = very homogeneous = homogeneous = quite not homogeneous = not homogeneous = very not homogeneous = marked not homogeneous | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 
| Pigmentary homogeneity clinical score variation | Homogeneity grade was determined according to specific reference clinical and photographic scales and to the following clinical score: 0 = very homogeneous = homogeneous = quite not homogeneous = not homogeneous = very not homogeneous = marked not homogeneous | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 
| Skin radiance clinical score variation | Skin radiance was evaluated using a 10 points scale from very poor to good | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 
| Skin plumpness clinical score variation | Skin plumpness was evaluated using a 10 points scale from very poor to good | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superficial skin hydration | Skin electrical capacitance value measured 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), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 
| Deep skin hydration | Tissue dielectric constant value of superficial and deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland) | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 
| Determination of roughness profilometric parameters | Nasolabial folds profilometric parameters measured by Primos compact portable device (GFMesstechnik). Ra is average roughness of the analysed profile, Rt is wrinkles total high, Rv is wrinkles maximum depth. | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) | 
| Tolerance evaluation | The food supplement tolerance will be evaluated considering: any adverse event related to the study treatment, which occurred during the study; any judgement reported by the volunteers. | Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5) |