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

Last updated: September 15, 2023
Sponsor: Seppic
Overall Status: Completed

Phase

N/A

Condition

Healthy Volunteers

Treatment

Placebo

Wheat Polar Lipid Complex Powder

Wheat Polar Lipid Complex Oil

Clinical Study ID

NCT06048354
IT0003398/21
  • Ages 30-60
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 cellsactivity),
  • 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 isperformed case by case by the experimenter but at least 1 month must be elapsedbetween a previous study on food supplement),
  • Willingness not to use chemical products or treatments on hair and nails (such as haircolour, 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 thestudy volunteers list their usual routine: sport activities, sleeping habits, etc. ),
  • Subjects under effective contraception (oral/not oral) if women of childbearingpotential; not expected to be changed during the trial,
  • Subjects who have not sun exposure (both natural or artificial) for at least twomonths
  • Subjects who accept not to expose in intensive way to UV rays during the whole studyduration,
  • Willingness not to use similar products that could interfere with the product to betested,
  • Subject aware of the study procedures and having signed an informed consent form.

Exclusion

Exclusion Criteria:

  • Subject does not meet the inclusion criteria,
  • Subject with known or suspected sensitization to one or more test formulationingredients,
  • 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 skinmetabolism/physiology,
  • Lipid metabolism disorders (hypercholesterolemia, hyperlipidemia) and followingtreatment for theses disease,
  • Subjects under locally pharmacological treatment on the skin area monitored during thetest,
  • Subjects under treatment with food supplements which could interfere with thefunctionality of the product under study,
  • Subjects which show skin alterations on the monitored area which could interfere withthe functionality of the product under study,
  • Subjects who underwent to botox, hyaluronic acid, collagen injections or each type offacial surgery in the past 6 months,
  • Severe concurrent diseases,
  • Adult protected by the law (under guardianship, or hospitalized in a public or privateinstitution, for a reason other than the research, or incarcerated),
  • Subject is unable to communicate or cooperate with the Investigator due to languageproblems, 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

Total Participants: 72
Treatment Group(s): 3
Primary Treatment: Placebo
Phase:
Study Start date:
February 08, 2022
Estimated Completion Date:
July 01, 2022

Study 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.

Connect with a study center

  • Complife Italia srl

    Milano, 20024
    Italy

    Site Not Available

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