Healthy VolunteersNCT06032598
Evaluation of the Anti-aging Efficacy of Two Dietary Supplements
A study testing Berry extract 1 and Berry extract 2 in people with Healthy Volunteers, run by Seppic at 1 site in Italy.
Trial summary
The study is aimed to assess the efficacy of two dietary supplements composed of berry extracts in reducing skin aging signs and improving skin complexion. 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?
- Berry extract 1 and Berry extract 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 2023to 5 Jan 2024
- 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 (limits of ±2 years old could be included)
- Phototypes from I to III
- Subject with uneven skin tone (grade 1-3 - internal clinical scale)
- Subject with visible Crow's feet wrinkles (≥2 according to Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)
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- Subject with mild-moderate skin slackness at cheek level (grade 1-3 - internal clinical scale).
- Willingness to not assume during the study period products other than the test product
- Subjects registered with National Health Service (NHS)
- Subjects certifying the truthfulness of the personal data disclosed to the investigator
- Subjects able to understand the language used in the investigation centre and the information given by the investigator
- Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
- The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study
- Commitment not to change the daily routine or the lifestyle
- Subjects who have not been recently involved in any other similar study (at least one month of wash-out)
- Subject under effective contraception (oral/not oral) therapy
- Subjects who accept not to expose in intensive way to UV rays during the whole study duration.
- Subject aware of the study procedures and having signed an informed consent form and privacy information form.
Who cannot join
- Subject does not meet the inclusion criteria,
- Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements
- Subjects participating or planning to participate in other clinical trials
- Subjects deprived of freedom by administrative or legal decision or under guardianship
- Subjects not able to be contacted in case of emergency
- Subjects admitted to a health or social facility
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- Subjects planning a hospitalisation during the study
- Subjects who participated in a similar study without respecting an adequate washout period
- Subjects 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 pharmacological treatments that are considered incompatible with the study requirement by the investigator
- Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Subject with known or suspected sensitization to one or more test formulation ingredients
- Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)
- Consumption of food supplement(s) and/or use of topical skincare products with whitening activity currently or within the past 4 weeks before the study
- Subjects accustomed to use tanning beds
- Subjects taking medication with photosensitizing potential, drugs and/or dietary supplements able to induce skin coloring, corticoids, currently or during the month before the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical-instrumental Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging Properties and Skin Complexion Improvement. A Double-blind, Randomized, Placebo-controlled Study
The study is aimed to assess the efficacy of two dietary supplements composed of berry extracts in reducing skin aging signs and improving skin complexion.
Read the detailed description
A double blind, parallel groups, placebo-controlled study is carried out on 90 healthy female subjects aged between 35 and 65 (±2) years old with phototypes from I to III, uneven skin tone, visible Crow's feet wrinkles and mild-moderate skin slackness at cheek level.
The study foresees 84 days of products intake. Evaluations of the parameters under study are performed at baseline, after 28, 56 and 84 days of products consumption.
- Conditions
- Healthy Volunteers
- Being tested
- Berry extract 1, Berry extract 2, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berry extract 1Dietary supplement
The study foresees the intake of 1 capsule per day during 84 days
Berry extract 2Dietary supplement
The study foresees the intake of 1 capsule per day during 84 days
PlaceboDietary supplement
The study foresees the intake of 1 capsule per day during 84 days
| Study group | Role | What they receive |
|---|---|---|
| Berry extract 1 | Experimental | Dietary supplement - Berry extract 1 Receives: Dietary Supplement: Berry extract 1 |
| Berry extract 2 | Experimental | Dietary supplement - Berry extract 2 Receives: Dietary Supplement: Berry extract 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: 28 days
Skin profilometry
Primos 3D
Measured: 56 days
Skin profilometry
Primos 3D
Measured: 84 days
Secondary outcomes (22)
Skin elasticity
Cutometer
Measured: Baseline
Skin elasticity
Cutometer
Measured: 28 days
Skin elasticity
Cutometer
Measured: 56 days
Skin elasticity
Cutometer
Measured: 84 days
Skin color
CIELab color space
Measured: Baseline
Skin color
CIELab color space
Measured: 28 days
Skin color
CIELab color space
Measured: 56 days
Skin color
CIELab color space
Measured: 84 days
Crow's feet
Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)
Measured: Baseline
Crow's feet
Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)
Measured: 28 days
Crow's feet
Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)
Measured: 56 days
Crow's feet
Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)
Measured: 84 days
Skin firmness
Clinical scoring (internal validated scale from 1 to 5, where: 1 = not firm skin and 5 = very firm skin)
Measured: Baseline
Skin firmness
Clinical scoring (internal validated scale from 1 to 5, where: 1 = not firm skin and 5 = very firm skin)
Measured: 28 days
Skin firmness
Clinical scoring (internal validated scale from 1 to 5, where: 1 = not firm skin and 5 = very firm skin)
Measured: 56 days
Skin firmness
Clinical scoring (internal validated scale from 1 to 5, where: 1 = not firm skin and 5 = very firm skin)
Measured: 84 days
Skin homogeneity improvment from baseline
Clinical scoring (internal validated scale from 1 to 4, where: 1 = no variation and 4 = evident variation)
Measured: 28 days
Skin homogeneity improvment from baseline
Clinical scoring (internal validated scale from 1 to 4, where: 1 = no variation and 4 = evident variation)
Measured: 56 days
Skin homogeneity improvment from baseline
Clinical scoring (internal validated scale from 1 to 4, where: 1 = no variation and 4 = evident variation)
Measured: 84 days
Self-assessment of product efficacy
Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
Measured: 84 days
Skin antioxidant potential
FRAP (Ferric Reducing Antioxidant Power) assay
Measured: Baseline
Skin antioxidant potential
FRAP (Ferric Reducing Antioxidant Power) assay
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start25 Sep 2023
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
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
- Ileana De Ponti, Study director, Complife Italia Srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032598
- Sponsor's protocol ID
- IT0003588/23
- Status last verified
- Aug 2023
- First submitted
- 4 Sep 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical-instrumental Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging Properties and Skin Complexion Improvement. A Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06032598
- Acronym / sponsor ID
- IT0003588/23
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- SeppicIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 13 Sep 2023 (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 is aimed to assess the efficacy of two dietary supplements composed of berry extracts in reducing skin aging signs and improving skin complexion.
Detailed description
A double blind, parallel groups, placebo-controlled study is carried out on 90 healthy female subjects aged between 35 and 65 (±2) years old with phototypes from I to III, uneven skin tone, visible Crow's feet wrinkles and mild-moderate skin slackness at cheek level.
The study foresees 84 days of products intake. Evaluations of the parameters under study are performed at baseline, after 28, 56 and 84 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 |
|---|---|---|
| Berry extract 1 | Experimental | Dietary Supplement: Berry extract 1Dietary supplement - Berry extract 1 |
| Berry extract 2 | Experimental | Dietary Supplement: Berry extract 2Dietary supplement - Berry extract 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 (18 listed)
- Healthy female subjects,
- Caucasian ethnicity,
- Age between 35 and 65 (limits of ±2 years old could be included)
- Phototypes from I to III
- Subject with uneven skin tone (grade 1-3 - internal clinical scale)
Key exclusion criteria (16 listed)
- Subject does not meet the inclusion criteria,
- Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements
- Subjects participating or planning to participate in other clinical trials
- Subjects deprived of freedom by administrative or legal decision or under guardianship
- Subjects not able to be contacted in case of emergency
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 |
|---|---|---|
| Berry extract 1The study foresees the intake of 1 capsule per day during 84 days | Dietary supplement | Berry extract 1 |
| Berry extract 2The study foresees the intake of 1 capsule per day during 84 days | Dietary supplement | Berry extract 2 |
| PlaceboThe study foresees the intake of 1 capsule per day during 84 days | Dietary supplement | Placebo |
Primary outcome
Skin profilometry
Time frame: Baseline
Primos 3D
Skin profilometry
Time frame: 28 days
Primos 3D
Skin profilometry
Time frame: 56 days
Primos 3D
Skin profilometry
Time frame: 84 days
Primos 3D
22 secondary outcomes
Skin elasticity
Time frame: Baseline
Skin elasticity
Time frame: 28 days
Skin elasticity
Time frame: 56 days
Skin elasticity
Time frame: 84 days
Skin color
Time frame: Baseline
Skin color
Time frame: 28 days
Skin color
Time frame: 56 days
Skin color
Time frame: 84 days
Crow's feet
Time frame: Baseline
Crow's feet
Time frame: 28 days
Crow's feet
Time frame: 56 days
Crow's feet
Time frame: 84 days
Skin firmness
Time frame: Baseline
Skin firmness
Time frame: 28 days
Skin firmness
Time frame: 56 days
Skin firmness
Time frame: 84 days
Skin homogeneity improvment from baseline
Time frame: 28 days
Skin homogeneity improvment from baseline
Time frame: 56 days
Skin homogeneity improvment from baseline
Time frame: 84 days
Self-assessment of product efficacy
Time frame: 84 days
Skin antioxidant potential
Time frame: Baseline
Skin antioxidant potential
Time frame: 84 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 24 Apr 2024.
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Screening Protocol
Pain
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.
Ileana De Ponti 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 Berry extract 1 and Berry extract 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 18 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 24 Apr 2024. 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 24 Apr 2024.