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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Wheat Polar Lipid Complex Oil; Dietary supplement: Wheat Polar Lipid Complex Powder

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20024
    • Complife Italia Srl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seppic
• Investigators: Study Director: Ileana De Ponti, Complife Italia S.r.l

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IT0003398/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No