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The study is aimed to assess the efficacy of two dietary supplements composed of a Wheat Polar Lipid Complex (WPLC) in reducing skin aging signs, in particular in improving firmness/elasticity, skin moisturization and skin surface properties.
A double blind, parallel groups, placebo-controlled study is carried out on 72 healthy female subjects aged between 30 and 60 years old showing slight-moderate clinical signs of skin aging over the face. The study foresees 56 days of products intake. Evaluations of the parameters under study are performed at baseline, after 14, 28 and 56 days of products consumption. Moreover post-treatment evaluations are performed 56 days after the end of product intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wheat Polar Lipid Complex Oil | Experimental | Dietary supplement - Wheat Polar Lipid Complex (Oil) |
|
| Wheat Polar Lipid Complex Powder | Experimental | Dietary supplement - Wheat Polar Lipid Complex (Powder) |
|
| Placebo | Placebo Comparator | Dietary supplement - Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wheat Polar Lipid Complex Oil | Dietary Supplement | The study foresees the intake of 2 capsules per day during 84 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin moisturization | Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin | Baseline |
| Skin moisturization | Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin | 14 days |
| Skin moisturization | Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin | 28 days |
| Skin moisturization | Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin | 56 days |
| Skin moisturization | Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin | 56 days post supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Skin elasticity | Skin elasticity measurement is based on the suction/elongation method and the subsequent release of the skin inside the opening of the instrument (Cutometer®) | Baseline |
| Skin elasticity |
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Inclusion criteria :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ileana De Ponti | Complife Italia Srl | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complife Italia srl | Milan | 20024 | Italy |
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| Wheat Polar Lipid Complex Powder | Dietary Supplement | The study foresees the intake of 2 capsules per day during 84 days |
|
| Placebo | Dietary Supplement | The study foresees the intake of 2 capsules per day during 84 days |
|
Skin elasticity measurement is based on the suction/elongation method and the subsequent release of the skin inside the opening of the instrument (Cutometer®)
| 14 days |
| Skin elasticity | Skin elasticity measurement is based on the suction/elongation method and the subsequent release of the skin inside the opening of the instrument (Cutometer®) | 28 days |
| Skin elasticity | Skin elasticity measurement is based on the suction/elongation method and the subsequent release of the skin inside the opening of the instrument (Cutometer®) | 56 days |
| Skin elasticity | Skin elasticity measurement is based on the suction/elongation method and the subsequent release of the skin inside the opening of the instrument (Cutometer®) | 56 days post supplementation |
| Transepidermal water loss | The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density | Baseline |
| Transepidermal water loss | The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density | 14 days |
| Transepidermal water loss | The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density | 28 days |
| Transepidermal water loss | The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density | 56 days |
| Transepidermal water loss | The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density | 56 days post supplementation |
| Skin roughness | Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | Baseline |
| Skin roughness | Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | 14 days |
| Skin roughness | Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | 28 days |
| Skin roughness | Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | 56 days |
| Skin roughness | Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | 56 days post supplementation |
| Skin smoothness | Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | Baseline |
| Skin smoothness | Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | 14 days |
| Skin smoothness | Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | 28 days |
| Skin smoothness | Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | 56 days |
| Skin smoothness | Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | 56 days post supplementation |
| Wrinkle depth | Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | Baseline |
| Wrinkle depth | Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | 14 days |
| Wrinkle depth | Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | 28 days |
| Wrinkle depth | Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | 56 days |
| Wrinkle depth | Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties | 56 days post supplementation |
| Self-assessment of product efficacy | Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree) | 56 days |
| Skin lipidic profile | Untargeted lipidomic analysis : Extraction of lipids from skin stripping and quantification by ultra-high performance liquid chromatography coupled to mass spectrometry (relative peak intensity) | Baseline |
| Skin lipidic profile | Untargeted lipidomic analysis : Extraction of lipids from skin stripping and quantification by ultra-high performance liquid chromatography coupled to mass spectrometry (relative peak intensity) | 56 days |