Clinical Evaluation of the Efficacy of a Dietary Supplement Claiming Anti-aging Properties and UV-protection

Clinical Evaluation of the Efficacy of a Dietary Supplement Claiming Anti-aging Properties and UV-protection in Healthy Adults: a Randomized, Double-blind, Placebo Controlled, Parallel, Clinical Trial

The study aims to assess the anti-aging and photoprotective efficacy of two active concentrations of a food supplement composed of Coriander Seed Oil (CSO).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Coriander Seed Oil - Dose 1; Dietary supplement: Coriander Seed Oil - Dose 2

Detailed Description

A double blind, parallel groups, placebo-controlled study is carried out on 90 female subjects aged between 35 and 65 years old with visible Crow's feet wrinkles and mild to moderate skin slackness.

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • San Martino Siccomario, Italy, 27028
    • Complife Italia S.r.l

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy female subjects
• Caucasian ethnicity
• Age between 35 and 65 years old (extremes included)
• Phototype I to III (with all skin types without any specific repartition)
• Visible Crow's feet wrinkles (> 2 according to Skin Aging Atlas - Caucasian Type - Bazin Roland) and mild to moderate skin slackness at cheek level (grade 1-3 - internal clinical scale)
• Subjects who have not been recently involved in any other similar study (at least 1 month of wash-out)
• Subjects registered with health social security or health social insurance
• Subjects having signed the Informed Consent Form (ICF) and Privacy Policy for their participation in the study and a photograph authorization
• Subjects able to understand the language used in the investigation center and the information given
• Subjects able to comply with the protocol and follow protocol constraints and specific requirements
• Willingness to use during all the study period only the product to be tested
• Willingness not to use similar products that could interfere with the expected product effect to be tested (e.g. with antiaging or soothing or UV protection efficacy)
• Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet 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
• Subjects who have not been involved in any sun test (for SPF evaluation) or tests that provide skin irradiation since less than two months

Exclusion Criteria:

• Subject is taking part or planning to participate to another clinical study in the same or in another investigation center
• Subject who is deprived of freedom by administrative or legal decision or under guardianship
• Subject admitted in a sanitary or social facilities
• Subject who is planning an hospitalization during the study
• Subjects under treatment with food supplements which could interfere with the functionality of the product under study
• Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (if women of childbearing potential)
• Subject has started or changed estrogen-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study
• Subject having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
• Subjects under radiotherapy, chemotherapy at any time
• Subject having a skin condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
• Pharmacological treatments (topic or systemic) known to interfere with skin metabolism/physiology
• Subjects under locally pharmacological/non-pharmacological treatment applied on the skin area monitored during the test
• Subject with known or suspected sensitization to one or more test formulation ingredients
• Subjects considered as not adequate to participate to the study by the investigator
• Adult protected by law (under control or hospitalized in public or private institutions for reasons other than research, or incarcerated)
• Subjects not able to communicate or cooperate with the investigator for problems related to language, mental retardation or impaired brain function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Dietary supplement - Placebo	Dietary supplement: Placebo; The study foresees the intake of 1 capsule per day during 56 days
Experimental: Coriander Seed Oil - Dose 1; Dietary supplement - Coriander Seed Oil dose 1	Dietary supplement: Coriander Seed Oil - Dose 1; The study foresees the intake of 1 capsule per day during 56 days
Experimental: Coriander Seed Oil - Dose 2; Dietary supplement - Coriander Seed Oil dose 2	Dietary supplement: Coriander Seed Oil - Dose 2; The study foresees the intake of 1 capsule per day during 56 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin profilometry	Primos 3D	Baseline
Skin profilometry	Primos 3D	28 days
Skin profilometry	Primos 3D	56 days
Skin profilometry	Primos 3D	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin elasticity	Cutometer	Baseline
Skin elasticity	Cutometer	28 days
Skin elasticity	Cutometer	56 days
Self-assessment of product efficacy	Questionnaire (10 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)	56 days
Skin elasticity	Cutometer	14 days
Transepidermal water loss	Tewameter	Baseline
Transepidermal water loss	Tewameter	14 days
Transepidermal water loss	Tewameter	28 days
Transepidermal water loss	Tewameter	56 days
Erythema index	Skin haemoglobin quantification by Mexameter 24h after UV exposure	Baseline
Erythema index	Skin haemoglobin quantification by Mexameter 24h after UV exposure	28 days
Erythema index	Skin haemoglobin quantification by Mexameter 24h after UV exposure	56 days
Skin inflammation (subgroup of 20 subjects)	TNF-alpha quantification by Enzyme-Linked Immunosorbent Assay on skin stripping performed before and 24h after UV exposure	Baseline
Skin inflammation (subgroup of 20 subjects)	TNF-alpha quantification by Enzyme-Linked Immunosorbent Assay on skin stripping performed before and 24h after UV exposure	56 days
Skin lipoxidation (subgroup of 20 subjects)	Malondialdehyde quantification by spectrophotometry on skin stripping performed before and 4h and 24h after UV exposure	Baseline
Skin lipoxidation (subgroup of 20 subjects)	Malondialdehyde quantification by spectrophotometry on skin stripping performed before and 4h and 24h after UV exposure	56 days

Collaborators and Investigators

• Sponsor: Seppic
• Investigators: Study Director: Eleonora Spartà, Complife Italia S.r.l

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Actual): January 3, 2025
• Study Completion (Actual): January 27, 2025

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IT0003160/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No