Clinical trial NCT06048354: Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging Properties
Official title: Double Blind, Randomized, Placebo Controlled Clinical and Instrumental Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging Properties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Seppic
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 72
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Skin moisturization
timeFrame: Baseline
measure: Skin moisturization
timeFrame: 14 days
measure: Skin moisturization
timeFrame: 28 days
measure: Skin moisturization
timeFrame: 56 days
measure: Skin moisturization
timeFrame: 56 days post supplementation
Secondary outcomes:
measure: Skin elasticity
timeFrame: Baseline
measure: Skin elasticity
timeFrame: 14 days
measure: Skin elasticity
timeFrame: 28 days
measure: Skin elasticity
timeFrame: 56 days
measure: Skin elasticity
timeFrame: 56 days post supplementation
measure: Transepidermal water loss
timeFrame: Baseline
measure: Transepidermal water loss
timeFrame: 14 days
measure: Transepidermal water loss
timeFrame: 28 days
measure: Transepidermal water loss
timeFrame: 56 days
measure: Transepidermal water loss
timeFrame: 56 days post supplementation
measure: Skin roughness
timeFrame: Baseline
measure: Skin roughness
timeFrame: 14 days
measure: Skin roughness
timeFrame: 28 days
measure: Skin roughness
timeFrame: 56 days
measure: Skin roughness
timeFrame: 56 days post supplementation
measure: Skin smoothness
timeFrame: Baseline
measure: Skin smoothness
timeFrame: 14 days
measure: Skin smoothness
timeFrame: 28 days
measure: Skin smoothness
timeFrame: 56 days
measure: Skin smoothness
timeFrame: 56 days post supplementation
measure: Wrinkle depth
timeFrame: Baseline
measure: Wrinkle depth
timeFrame: 14 days
measure: Wrinkle depth
timeFrame: 28 days
measure: Wrinkle depth
timeFrame: 56 days
measure: Wrinkle depth
timeFrame: 56 days post supplementation
measure: Self-assessment of product efficacy
timeFrame: 56 days
measure: Skin lipidic profile
timeFrame: Baseline
measure: Skin lipidic profile
timeFrame: 56 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Complife Italia srl
Study officials:
affiliation: Complife Italia S.r.l
name: Ileana De Ponti
role: STUDY_DIRECTOR
References: