Healthy VolunteersNCT06048354
Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging Properties
A study testing Wheat Polar Lipid Complex Oil and Wheat Polar Lipid Complex Powder in people with Healthy Volunteers, run by Seppic at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Wheat Polar Lipid Complex Oil and Wheat Polar Lipid Complex Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 8 Feb 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Wheat Polar Lipid Complex Oil, Wheat Polar Lipid Complex Powder, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat Polar Lipid Complex OilDietary supplement
The study foresees the intake of 2 capsules per day during 84 days
Wheat Polar Lipid Complex PowderDietary supplement
The study foresees the intake of 2 capsules per day during 84 days
PlaceboDietary supplement
The study foresees the intake of 2 capsules per day during 84 days
| Study group | Role | What they receive |
|---|---|---|
| Wheat Polar Lipid Complex Oil | Experimental | Dietary supplement - Wheat Polar Lipid Complex (Oil) Receives: Dietary Supplement: Wheat Polar Lipid Complex Oil |
| Wheat Polar Lipid Complex Powder | Experimental | Dietary supplement - Wheat Polar Lipid Complex (Powder) Receives: Dietary Supplement: Wheat Polar Lipid Complex Powder |
| Placebo | Placebo comparator | Dietary supplement - Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin moisturization
Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin
Measured: Baseline
Skin moisturization
Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin
Measured: 14 days
Skin moisturization
Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin
Measured: 28 days
Skin moisturization
Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin
Measured: 56 days
Skin moisturization
Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin
Measured: 56 days post supplementation
Secondary outcomes (28)
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®)
Measured: 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®)
Measured: 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®)
Measured: 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®)
Measured: 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®)
Measured: 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
Measured: Baseline
Transepidermal water loss
The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density
Measured: 14 days
Transepidermal water loss
The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density
Measured: 28 days
Transepidermal water loss
The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density
Measured: 56 days
Transepidermal water loss
The water evaporating from the skin is measured using a probe (Tewameter®) that detect changes in water vapor density
Measured: 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
Measured: Baseline
Skin roughness
Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Measured: 14 days
Skin roughness
Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Measured: 28 days
Skin roughness
Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Measured: 56 days
Skin roughness
Skin roughness (Rz parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Measured: 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
Measured: Baseline
Skin smoothness
Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Measured: 14 days
Skin smoothness
Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Measured: 28 days
Skin smoothness
Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Measured: 56 days
Skin smoothness
Skin smoothness (Ra parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Measured: 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
Measured: Baseline
Wrinkle depth
Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Measured: 14 days
Wrinkle depth
Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Measured: 28 days
Wrinkle depth
Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Measured: 56 days
Wrinkle depth
Wrinkle depth (Sv parameter) is measured by Primos CR, a 3D scanner using fringe projection to measure skin surface properties
Measured: 56 days post supplementation
Self-assessment of product efficacy
Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
Measured: 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)
Measured: 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)
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 Feb 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seppic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ileana De Ponti, Study director, Complife Italia Srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048354
- Sponsor's protocol ID
- IT0003398/21
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Placebo Controlled Clinical and Instrumental Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging Properties
- ClinicalTrials.gov ID
- NCT06048354
- Acronym / sponsor ID
- IT0003398/21
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- SeppicIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wheat Polar Lipid Complex Oil | Experimental | Dietary Supplement: Wheat Polar Lipid Complex OilDietary supplement - Wheat Polar Lipid Complex (Oil) |
| Wheat Polar Lipid Complex Powder | Experimental | Dietary Supplement: Wheat Polar Lipid Complex PowderDietary supplement - Wheat Polar Lipid Complex (Powder) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary supplement - Placebo |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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),
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheat Polar Lipid Complex OilThe study foresees the intake of 2 capsules per day during 84 days | Dietary supplement | Wheat Polar Lipid Complex Oil |
| Wheat Polar Lipid Complex PowderThe study foresees the intake of 2 capsules per day during 84 days | Dietary supplement | Wheat Polar Lipid Complex Powder |
| PlaceboThe study foresees the intake of 2 capsules per day during 84 days | Dietary supplement | Placebo |
Primary outcome
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
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
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
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
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
28 secondary outcomes
Skin elasticity
Time frame: Baseline
Skin elasticity
Time frame: 14 days
Skin elasticity
Time frame: 28 days
Skin elasticity
Time frame: 56 days
Skin elasticity
Time frame: 56 days post supplementation
Transepidermal water loss
Time frame: Baseline
Transepidermal water loss
Time frame: 14 days
Transepidermal water loss
Time frame: 28 days
Transepidermal water loss
Time frame: 56 days
Transepidermal water loss
Time frame: 56 days post supplementation
Skin roughness
Time frame: Baseline
Skin roughness
Time frame: 14 days
Skin roughness
Time frame: 28 days
Skin roughness
Time frame: 56 days
Skin roughness
Time frame: 56 days post supplementation
Skin smoothness
Time frame: Baseline
Skin smoothness
Time frame: 14 days
Skin smoothness
Time frame: 28 days
Skin smoothness
Time frame: 56 days
Skin smoothness
Time frame: 56 days post supplementation
Wrinkle depth
Time frame: Baseline
Wrinkle depth
Time frame: 14 days
Wrinkle depth
Time frame: 28 days
Wrinkle depth
Time frame: 56 days
Wrinkle depth
Time frame: 56 days post supplementation
Self-assessment of product efficacy
Time frame: 56 days
Skin lipidic profile
Time frame: Baseline
Skin lipidic profile
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ileana De Ponti study director
Complife Italia Srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheat Polar Lipid Complex Oil and Wheat Polar Lipid Complex Powder in people with Healthy Volunteers, run by Seppic at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin moisturization (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.