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Completed

NCT Number: NCT00975728

High Total Antioxidant Capacity Products Added to Diet

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.

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Key information

Conditions

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DermIng S.r.l

Monza, MB, 20052, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alixir - Pomegranate, apple and Açai drink / Placebo

Dietary Supplement

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Skin evaluations (Skin texture - Hydration - Plastoelasticity - Epicutaneous pH)

    Time frame: T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis

  2. Determination on blood samples of antioxidants diet components

    Time frame: T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis

Sponsors and collaborators

Lead sponsor

Derming SRL

Other

Collaborators

  • University of Bologna

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 11, 2009
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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