High Total Antioxidant Capacity Products Added to Diet

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the antioxidant activity on skin photo induced damage of a food supplement and its anti-age properties.

Detailed Description
-----------------
To determine the antioxidant activity of the tested product the following clinical and instrumental evaluations will be performed: Evaluation of experimentally induced erythema inhibition: in basal conditions, before starting the assumption of the test product/placebo, and at T4, T8, T12, T16 weeks, each volunteer wll be exposed at the level of dorsal skin to six incremental doses of UVR (ultraviolet radiations mJ/cm2 ) in order to determine the MED (minimal erythema dose of unprotected skin). 20+/-4 hours after the UV exposure clinical and instrumental (optical densitometry) evaluations of skin erythema and photographic documentation (only on 16 preselected cases) will be performed. Blood samples collection for the determination of the principal antioxidants concentration (for example: lutein, carotene, lycopene and E vitamin): at T0, T4, T8 and T12 blood samples (5 ml of venous blood) will be collected on each volunteer by the Medical Staff. The samples will be sent to an external laboratory for haematologic control task. To determine the anti-age properties of the tested product the following clinical and instrumental evaluations will be performed: Non Invasive, instrumental evaluation of principal skin parameters: epicutaneous pH, skin hydration (skin electrical capacitance), skin firmness (plastoelasticity), skin texture (skin surface irregularity index - FFT on skin replicas) measurements will be performed at T0 and T8 mono-laterally at level of volar forearm medium third, left or right side according to a previously defined randomization list. Clinical pictures with UV flash (Wood's light): at T0 and T8, 20 preselected cases of fairy skinned volunteers (selected on the basis of clinical ananmnesis regarding photosensitivity) will be submitted to the realization of clinical pictures at the level of the face using a special UV flash, able to highlight melanin spots, even if not yet visible at the naked eye. Moreover aim of the study is also to evaluate the best dosage of the beverage (1 or 2 servings of 250 ml/a day).

Official Title
-----------------
High Total Antioxidant Capacity (TAC) Products Added to Diet: Clinical and Instrumental Evaluation of Their Effect on Skin Surface Parameters and on Photo-induced Acute Damage of the Skin (Double Blind Clinical Study vs Placebo)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult volunteers of both sexes, between 30 and 60 years of age Phototype II or III ( Fitzpatrick's classification) Volunteers in a good general state of health in the Investigator opinion Volunteers not taking drugs or undergoing surgical procedure Volunteers who are giving a written informed consent Exclusion Criteria: pregnancy lactation smoking >10 cigarettes per day drinking more then one glass of wine per day drinking super-alcoholics assumption of food supplement change in the normal habits in the last month participation in a similar study during the previous 3 months insufficient adhesion to the study protocol dermatological disease clinical and significant skin condition on the test area (e.g. lesions, scars,malformations) diabetes endocrine disease hepatic, renal or cardiac disorder cancer topical drugs or surgical procedure on the test areas during the previous 3 months systemic corticosteroids aspirin or non-steroid anti-inflammatory drugs (FANS) diuretic drugs antibiotics and chemotherapics psychotropic drugs retinoids psoralens cardiologic and vascular drugs

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 Product 825 (2-servings day)<br>30 subjects drinking 2 servings day of Product 825 for 8 weeks | Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo<br>* 250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks<br>* Other names: Açai drink;|
| Experimental: Group 1 Product 824 (2 servings-day)<br>30 subjects drinking 2 servings-day of Product 824 for 8 weeks | Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo<br>* 250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks<br>* Other names: Açai drink;|
| Experimental: Group 2 Product 825 (1 serving-day)<br>30 subjects drinking 1 serving-day of Product 825 for 8 weeks | Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo<br>* 250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks<br>* Other names: Açai drink;|
| Experimental: Gruop 2 Product 824 (1 serving-day)<br>30 subjects drinking 1 serving-day of Product 824 for 8 weeks | Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo<br>* 250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks<br>* Other names: Açai drink;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema evaluation (MED-optical densitometry) |  | T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment), T12 and T16 (follow-up visits - 12 and 16 weeks after T0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin evaluations (Skin texture - Hydration - Plastoelasticity - Epicutaneous pH) |  | T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis | 
| Determination on blood samples of antioxidants diet components |  | T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-oxidant, Açai, Food supplement, Sun protection, Skin erythema prevention, Anti-oxidant efficacy, Anti-age efficacy, Skin photo-induced damage protection