Skip to main content
OpenTrials
Completed

NCT Number: NCT06048354

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Complife Italia srl

Milan, 20024, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wheat Polar Lipid Complex Oil

Dietary Supplement

The study foresees the intake of 2 capsules per day during 84 days

Wheat Polar Lipid Complex Powder

Dietary Supplement

The study foresees the intake of 2 capsules per day during 84 days

Placebo

Dietary Supplement

The study foresees the intake of 2 capsules per day during 84 days

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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®)

  2. 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®)

  3. 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®)

  4. 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®)

  5. 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®)

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. Self-assessment of product efficacy

    Time frame: 56 days

    Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)

  27. 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)

  28. 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)

Sponsors and collaborators

Lead sponsor

Seppic

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.