High Total Antioxidant Capacity Products Added to Diet

Phase 3

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo

• Registration Number: NCT00975728
• Lead Sponsor: Derming SRL

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:

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).

Study Timeline

• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Study Start: 2010-02
• Primary Completion: 2010-07
• Study Completion: 2010-10
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Gruop 2 Product 824 (1 serving-day)	Alixir - Pomegranate, apple and Açai drink / Placebo	30 subjects drinking 1 serving-day of Product 824 for 8 weeks
Group 1 Product 825 (2-servings day)	Alixir - Pomegranate, apple and Açai drink / Placebo	30 subjects drinking 2 servings day of Product 825 for 8 weeks
Group 1 Product 824 (2 servings-day)	Alixir - Pomegranate, apple and Açai drink / Placebo	30 subjects drinking 2 servings-day of Product 824 for 8 weeks
Group 2 Product 825 (1 serving-day)	Alixir - Pomegranate, apple and Açai drink / Placebo	30 subjects drinking 1 serving-day of Product 825 for 8 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

DermIng S.r.l; 🇮🇹 Monza, MB, Italy