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

NCT06048354 | Completed

• 1 other identifier: IT0003398/21
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• Skin moisturization

  Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin

  Baseline

• Skin moisturization

  Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin

  14 days

• Skin moisturization

  Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin

  28 days

• Skin moisturization

  Skin moisturization is measured by the Corneometer®, which analyze the dielectric constant and therefore the water content of the skin

  56 days

• Skin moisturization

  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 Outcomes (28)

• Skin elasticity

  Baseline

• Skin elasticity

  14 days

• Skin elasticity

  28 days

• Skin elasticity

  56 days

• Skin elasticity

  56 days post supplementation

Study Arms (3)

Wheat Polar Lipid Complex Oil

EXPERIMENTAL

Dietary supplement - Wheat Polar Lipid Complex (Oil)

Dietary Supplement: Wheat Polar Lipid Complex Oil

Wheat Polar Lipid Complex Powder

EXPERIMENTAL

Dietary supplement - Wheat Polar Lipid Complex (Powder)

Dietary Supplement: Wheat Polar Lipid Complex Powder

Placebo

PLACEBO COMPARATOR

Dietary supplement - Placebo

Dietary Supplement: Placebo

Interventions

Wheat Polar Lipid Complex Oil DIETARY_SUPPLEMENT

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

Wheat Polar Lipid Complex Oil

Wheat Polar Lipid Complex Powder DIETARY_SUPPLEMENT

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

Wheat Polar Lipid Complex Powder

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seppic: lead

Study Sites (1)

Complife Italia srl

Milan, 20024, Italy

Location

Study Officials

• Ileana De Ponti

  Complife Italia S.r.l

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 21, 2023
• Study Start: February 8, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

IT (1)