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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: Wheat Polar Lipid Complex Powder; Dietary Supplement: Placebo; Dietary Supplement: Wheat Polar Lipid Complex Oil

• Registration Number: NCT06048354
• Lead Sponsor: Seppic

Brief 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.

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 Timeline

• Study Start: 2022-02-08
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Study First Submitted: 2023-08-31
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-15
• Last Update Submitted: 2023-09-15
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wheat Polar Lipid Complex Powder	Wheat Polar Lipid Complex Powder	Dietary supplement - Wheat Polar Lipid Complex (Powder)
Placebo	Placebo	Dietary supplement - Placebo
Wheat Polar Lipid Complex Oil	Wheat Polar Lipid Complex Oil	Dietary supplement - Wheat Polar Lipid Complex (Oil)

Primary Outcome Measures

Name	Time	Method
Skin moisturization	56 days post supplementation	Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin

Secondary Outcome Measures

Name	Time	Method
Transepidermal water loss	56 days post supplementation	The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density
Self-assessment of product efficacy	56 days	Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
Skin lipidic profile	56 days	Untargeted lipidomic analysis : Extraction of lipids from skin stripping and quantification by ultra-high performance liquid chromatography coupled to mass spectrometry (relative peak intensity)
Skin elasticity	56 days post supplementation	Skin elasticity measurement is based on the suction/elongation method and the subsequent release of the skin inside the opening of the instrument (Cutometer®)
Skin smoothness	56 days post supplementation	Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Wrinkle depth	56 days post supplementation	Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Skin roughness	56 days post supplementation	Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties

Trial Locations

Locations (1)

Complife Italia srl; 🇮🇹 Milano, Italy