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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06048354
• Other study ID #: IT0003398/21
• Status: Completed
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2023
• Source: Seppic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Wheat Polar Lipid Complex Oil
The study foresees the intake of 2 capsules per day during 84 days
• Wheat Polar Lipid Complex Powder
The study foresees the intake of 2 capsules per day during 84 days
• Placebo
The study foresees the intake of 2 capsules per day during 84 days

Locations

Country	Name	City	State
Italy	Complife Italia srl	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Seppic

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin moisturization	Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin	Baseline
Primary	Skin moisturization	Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin	14 days
Primary	Skin moisturization	Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin	28 days
Primary	Skin moisturization	Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin	56 days
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Transepidermal water loss	The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density	Baseline
Secondary	Transepidermal water loss	The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density	14 days
Secondary	Transepidermal water loss	The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density	28 days
Secondary	Transepidermal water loss	The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density	56 days
Secondary	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
Secondary	Skin roughness	Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties	Baseline
Secondary	Skin roughness	Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties	14 days
Secondary	Skin roughness	Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties	28 days
Secondary	Skin roughness	Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties	56 days
Secondary	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
Secondary	Skin smoothness	Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties	Baseline
Secondary	Skin smoothness	Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties	14 days
Secondary	Skin smoothness	Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties	28 days
Secondary	Skin smoothness	Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties	56 days
Secondary	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
Secondary	Wrinkle depth	Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties	Baseline
Secondary	Wrinkle depth	Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties	14 days
Secondary	Wrinkle depth	Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties	28 days
Secondary	Wrinkle depth	Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties	56 days
Secondary	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
Secondary	Self-assessment of product efficacy	Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)	56 days
Secondary	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
Secondary	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