Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging Properties

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Double Blind, Randomized, Placebo Controlled Clinical and Instrumental Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging Properties

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Wheat Polar Lipid Complex Oil
* Dietary Supplement: Wheat Polar Lipid Complex Powder
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Healthy female subjects, Caucasian ethnicity, Age between 30 and 60 years old (extremes included), Wrinkles related to chronological ageing (from mild to moderate), Wrinkles related to photo-ageing (medium photo-ageing signs, dry and devitalized skin, asphyxia, pale and greyish skin, early ageing signs caused by a slowing in the cells activity), Subjects with dry skin defined with corneometric index < 50 a.u., Body mass index BMI between 19 and 30, At least 10 menopause women per group, Subjects who have not been recently involved in any other similar study (evaluation is performed case by case by the experimenter but at least 1 month must be elapsed between a previous study on food supplement), Willingness not to use chemical products or treatments on hair and nails (such as hair colour, straightening, permanent nail polish) in the two weeks preceding T56 visit, Willingness to not use during the study period products other than the test product, Willingness to not vary the normal diet and daily routine (at the beginning of the study volunteers list their usual routine: sport activities, sleeping habits, etc. ), Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial, Subjects who have not sun exposure (both natural or artificial) for at least two months Subjects who accept not to expose in intensive way to UV rays during the whole study duration, Willingness not to use similar products that could interfere with the product to be tested, Subject aware of the study procedures and having signed an informed consent form. Exclusion Criteria: Subject does not meet the inclusion criteria, Subject with known or suspected sensitization to one or more test formulation ingredients, Any condition that the principal investigator deems inappropriate for participation, Pregnant/breastfeeding female or who have planned a pregnancy during the study period, Pharmacological treatments (topic or systemic) known to interfere with skin metabolism/physiology, Lipid metabolism disorders (hypercholesterolemia, hyperlipidemia) and following treatment for theses disease, Subjects under locally pharmacological treatment on the skin area monitored during the test, Subjects under treatment with food supplements which could interfere with the functionality of the product under study, Subjects which show skin alterations on the monitored area which could interfere with the functionality of the product under study, Subjects who underwent to botox, hyaluronic acid, collagen injections or each type of facial surgery in the past 6 months, Severe concurrent diseases, Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated), Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function, Subjects resulting positive to Sars-Cov. 19 in the past 6 months/ during the study Subjects not presenting a valid Greenpass.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wheat Polar Lipid Complex Oil<br>Dietary supplement - Wheat Polar Lipid Complex (Oil) | Dietary Supplement: Wheat Polar Lipid Complex Oil<br>* The study foresees the intake of 2 capsules per day during 84 days<br>|
| Experimental: Wheat Polar Lipid Complex Powder<br>Dietary supplement - Wheat Polar Lipid Complex (Powder) | Dietary Supplement: Wheat Polar Lipid Complex Powder<br>* The study foresees the intake of 2 capsules per day during 84 days<br>|
| Placebo Comparator: Placebo<br>Dietary supplement - Placebo | Dietary Supplement: Placebo<br>* The study foresees the intake of 2 capsules per day during 84 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |