Healthy VolunteersNCT06571409
Clinical Evaluation of the Efficacy of a Dietary Supplement Claiming Anti-aging Properties and UV-protection
A study testing Coriander Seed Oil - Dose 1 and Coriander Seed Oil - Dose 2 in people with Healthy Volunteers, run by Seppic at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Coriander Seed Oil - Dose 1 and Coriander Seed Oil - Dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteItaly
- Study dates
- 25 Sep 2024to 27 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Coriander Seed Oil - Dose 1, Coriander Seed Oil - Dose 2, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coriander Seed Oil - Dose 1Dietary supplement
The study foresees the intake of 1 capsule per day during 56 days
Coriander Seed Oil - Dose 2Dietary supplement
The study foresees the intake of 1 capsule per day during 56 days
PlaceboDietary supplement
The study foresees the intake of 1 capsule per day during 56 days
| Study group | Role | What they receive |
|---|---|---|
| Coriander Seed Oil - Dose 1 | Experimental | Dietary supplement - Coriander Seed Oil dose 1 Receives: Dietary Supplement: Coriander Seed Oil - Dose 1 |
| Coriander Seed Oil - Dose 2 | Experimental | Dietary supplement - Coriander Seed Oil dose 2 Receives: Dietary Supplement: Coriander Seed Oil - Dose 2 |
| Placebo | Placebo comparator | Dietary supplement - Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin profilometry
Primos 3D
Measured: Baseline
Skin profilometry
Primos 3D
Measured: 14 days
Skin profilometry
Primos 3D
Measured: 28 days
Skin profilometry
Primos 3D
Measured: 56 days
Secondary outcomes (16)
Skin elasticity
Cutometer
Measured: Baseline
Skin elasticity
Cutometer
Measured: 14 days
Skin elasticity
Cutometer
Measured: 28 days
Skin elasticity
Cutometer
Measured: 56 days
Transepidermal water loss
Tewameter
Measured: Baseline
Transepidermal water loss
Tewameter
Measured: 14 days
Transepidermal water loss
Tewameter
Measured: 28 days
Transepidermal water loss
Tewameter
Measured: 56 days
Erythema index
Skin haemoglobin quantification by Mexameter 24h after UV exposure
Measured: Baseline
Erythema index
Skin haemoglobin quantification by Mexameter 24h after UV exposure
Measured: 28 days
Erythema index
Skin haemoglobin quantification by Mexameter 24h after UV exposure
Measured: 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
Measured: 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
Measured: 56 days
Skin lipoxidation (subgroup of 20 subjects)
Malondialdehyde quantification by spectrophotometry on skin stripping performed before and 4h and 24h after UV exposure
Measured: Baseline
Skin lipoxidation (subgroup of 20 subjects)
Malondialdehyde quantification by spectrophotometry on skin stripping performed before and 4h and 24h after UV exposure
Measured: 56 days
Self-assessment of product efficacy
Questionnaire (10 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start25 Sep 2024
- Primary completion3 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seppic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eleonora Spartà, Study director, Complife Italia Srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571409
- Sponsor's protocol ID
- IT0003160/24
- Status last verified
- Jan 2025
- First submitted
- 22 Aug 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06571409
- Acronym / sponsor ID
- IT0003160/24
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- SeppicIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coriander Seed Oil - Dose 1 | Experimental | Dietary Supplement: Coriander Seed Oil - Dose 1Dietary supplement - Coriander Seed Oil dose 1 |
| Coriander Seed Oil - Dose 2 | Experimental | Dietary Supplement: Coriander Seed Oil - Dose 2Dietary supplement - Coriander Seed Oil dose 2 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary supplement - Placebo |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coriander Seed Oil - Dose 1The study foresees the intake of 1 capsule per day during 56 days | Dietary supplement | Coriander Seed Oil - Dose 1 |
| Coriander Seed Oil - Dose 2The study foresees the intake of 1 capsule per day during 56 days | Dietary supplement | Coriander Seed Oil - Dose 2 |
| PlaceboThe study foresees the intake of 1 capsule per day during 56 days | Dietary supplement | Placebo |
Primary outcome
Skin profilometry
Time frame: Baseline
Primos 3D
Skin profilometry
Time frame: 14 days
Primos 3D
Skin profilometry
Time frame: 28 days
Primos 3D
Skin profilometry
Time frame: 56 days
Primos 3D
16 secondary outcomes
Skin elasticity
Time frame: Baseline
Skin elasticity
Time frame: 14 days
Skin elasticity
Time frame: 28 days
Skin elasticity
Time frame: 56 days
Transepidermal water loss
Time frame: Baseline
Transepidermal water loss
Time frame: 14 days
Transepidermal water loss
Time frame: 28 days
Transepidermal water loss
Time frame: 56 days
Erythema index
Time frame: Baseline
Erythema index
Time frame: 28 days
Erythema index
Time frame: 56 days
Skin inflammation (subgroup of 20 subjects)
Time frame: Baseline
Skin inflammation (subgroup of 20 subjects)
Time frame: 56 days
Skin lipoxidation (subgroup of 20 subjects)
Time frame: Baseline
Skin lipoxidation (subgroup of 20 subjects)
Time frame: 56 days
Self-assessment of product efficacy
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleonora Spartà study director
Complife Italia Srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coriander Seed Oil - Dose 1 and Coriander Seed Oil - Dose 2 in people with Healthy Volunteers, run by Seppic at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin profilometry (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.