High Total Antioxidant Capacity Products Added to Diet

This study has been completed.
Sponsor:
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
  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:
  • Barilla Alixir (code 824/825)
  • Anti-oxidant drink
  • Açai drink
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:
  • Barilla Alixir (code 824/825)
  • Anti-oxidant drink
  • Açai drink
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:
  • Barilla Alixir (code 824/825)
  • Anti-oxidant drink
  • Açai drink
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:
  • Barilla Alixir (code 824/825)
  • Anti-oxidant drink
  • Açai drink

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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975728

Locations
Italy
DermIng S.r.l
Monza, MB, Italy, 20052
Sponsors and Collaborators
Derming SRL
University of Bologna
Investigators
Principal Investigator: Adele Sparavigna, Doctor Derming SRL
  More Information

Additional Information:
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 July 22, 2014