High Total Antioxidant Capacity Products Added to Diet
This study has been completed.
Sponsor:
Derming SRL
Collaborator:
University of Bologna
Information provided by:
Derming SRL
ClinicalTrials.gov Identifier:
NCT00975728
First received: September 10, 2009
Last updated: June 22, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Derming SRL:
Primary Outcome Measures:
- Erythema evaluation (MED-optical densitometry) [ Time Frame: T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment), T12 and T16 (follow-up visits - 12 and 16 weeks after T0) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Skin evaluations (Skin texture - Hydration - Plastoelasticity - Epicutaneous pH) [ Time Frame: T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis ] [ Designated as safety issue: Yes ]
- Determination on blood samples of antioxidants diet components [ Time Frame: T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis ] [ Designated as safety issue: Yes ]
| Enrollment: | 120 |
| Study Start Date: | February 2010 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1 Product 825 (2-servings day)
30 subjects drinking 2 servings day of Product 825 for 8 weeks
|
Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo
250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks
Other Names:
|
|
Experimental: Group 1 Product 824 (2 servings-day)
30 subjects drinking 2 servings-day of Product 824 for 8 weeks
|
Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo
250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks
Other Names:
|
|
Experimental: Group 2 Product 825 (1 serving-day)
30 subjects drinking 1 serving-day of Product 825 for 8 weeks
|
Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo
250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks
Other Names:
|
|
Experimental: Gruop 2 Product 824 (1 serving-day)
30 subjects drinking 1 serving-day of Product 824 for 8 weeks
|
Dietary Supplement: Alixir - Pomegranate, apple and Açai drink / Placebo
250 ml/day Alixir/Placebo for Group 2 for 8 weeks 500 ml/day Alixir/Placebo for Group 1 for 8 weeks
Other Names:
|
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).
Eligibility| Ages Eligible for Study: | 30 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
Additional Information:
Investigator center 
Sponsor 
No publications provided
| Responsible Party: | Adele Sparavigna, DermIng S.r.l. |
| ClinicalTrials.gov Identifier: | NCT00975728 History of Changes |
| Other Study ID Numbers: | DermIng E0709 |
| Study First Received: | September 10, 2009 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Derming SRL:
|
Anti-oxidant Açai Food supplement Sun protection |
Skin erythema prevention Anti-oxidant efficacy Anti-age efficacy Skin photo-induced damage protection |
Additional relevant MeSH terms:
|
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013