High Total Antioxidant Capacity Products Added to Diet

Derming

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00975728

DermIng E0709

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

120 participants in 4 patient groups

Group 1 Product 825 (2-servings day)

Experimental group

Description:

30 subjects drinking 2 servings day of Product 825 for 8 weeks

Treatment:

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

Group 1 Product 824 (2 servings-day)

Experimental group

Description:

30 subjects drinking 2 servings-day of Product 824 for 8 weeks

Treatment:

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

Group 2 Product 825 (1 serving-day)

Experimental group

Description:

30 subjects drinking 1 serving-day of Product 825 for 8 weeks

Treatment:

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

Gruop 2 Product 824 (1 serving-day)

Experimental group

Description:

30 subjects drinking 1 serving-day of Product 824 for 8 weeks

Treatment:

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