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

September 15, 2023 updated by: Seppic

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Skin moisturization
Time Frame: Baseline
Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin
Baseline
Skin moisturization
Time Frame: 14 days
Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin
14 days
Skin moisturization
Time Frame: 28 days
Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin
28 days
Skin moisturization
Time Frame: 56 days
Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin
56 days
Skin moisturization
Time Frame: 56 days post supplementation
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Skin elasticity
Time Frame: Baseline
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
Time Frame: 14 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
Time Frame: 28 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®)
28 days
Skin elasticity
Time Frame: 56 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®)
56 days
Skin elasticity
Time Frame: 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®)
56 days post supplementation
Transepidermal water loss
Time Frame: Baseline
The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density
Baseline
Transepidermal water loss
Time Frame: 14 days
The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density
14 days
Transepidermal water loss
Time Frame: 28 days
The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density
28 days
Transepidermal water loss
Time Frame: 56 days
The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density
56 days
Transepidermal water loss
Time Frame: 56 days post supplementation
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
Time Frame: Baseline
Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Baseline
Skin roughness
Time Frame: 14 days
Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
14 days
Skin roughness
Time Frame: 28 days
Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
28 days
Skin roughness
Time Frame: 56 days
Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
56 days
Skin roughness
Time Frame: 56 days post supplementation
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
Time Frame: Baseline
Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Baseline
Skin smoothness
Time Frame: 14 days
Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
14 days
Skin smoothness
Time Frame: 28 days
Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
28 days
Skin smoothness
Time Frame: 56 days
Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
56 days
Skin smoothness
Time Frame: 56 days post supplementation
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
Time Frame: Baseline
Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Baseline
Wrinkle depth
Time Frame: 14 days
Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
14 days
Wrinkle depth
Time Frame: 28 days
Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
28 days
Wrinkle depth
Time Frame: 56 days
Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
56 days
Wrinkle depth
Time Frame: 56 days post supplementation
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
Time Frame: 56 days
Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
56 days
Skin lipidic profile
Time Frame: Baseline
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
Time Frame: 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)
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seppic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ileana De Ponti, Complife Italia S.r.l

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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