High Total Antioxidant Capacity Products Added to Diet
Condition: Healthy
Study type: Interventional
Phase: Phase 3

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:

        1. 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.

        2. 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:

        1. 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.

        2. 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).
    

Intervention name(s): Alixir - Pomegranate, apple and Açai drink / Placebo
Intervention type(s): Dietary Supplement
Intervention description(s): 250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks
Other intervention name(s): Barilla Alixir (code 824/825); Anti-oxidant drink; Açai drink
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anti-oxidant; Açai; Food supplement; Sun protection; Skin erythema prevention; Anti-oxidant efficacy; Anti-age efficacy; Skin photo-induced damage protection