Skin HealthOPTIHUDNCT05128240
Nutritional Study of Fish Oil in Skin Quality in Healthy Women
A study testing Ceto 10 in people with Skin Health, run by Epax Norway AS at 1 site in Norway.
Trial summary
The skin acts as a barrier against the external environment and prevents water loss from the body. Aging is a natural process leading to changes in the skin and fish oil has been shown to prevent inflammation, hyperpigmentation and UV-damage. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Ceto 10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 23 Aug 2021to 1 Mar 2022
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy women in the age of 30-65
- Able to follow the following dietary restriction for 4 months (4 weeks wash-out, 3 months intervention):
- Do not take omega-3 supplements
- do not take supplements containing vitamin A
- do not take supplements containing collagen
- try to avoid using skin products containing vitamin A
- do not undergo skin treatment
Who cannot join
- Pregnancy or breast feeding known allergy to seafood skin treatment the last 6 months planned skin treatment during the study period
- -
Trial locations and contacts
1 site in 1 country.
Derek Tobin, PhD contact
Norway1 site, 1 recruiting
- Recruiting
Møreforsking AS
Ålesund, 6006
Lise Midtbø, PhD
About this study
Official title: A Randomised, Two-armed, Double-blinded Nutritional Study of Fish Oil on Skin Quality in Healthy Women
The skin acts as a barrier against the external environment and prevents water loss from the body. Aging is a natural process leading to changes in the skin and fish oil has been shown to prevent inflammation, hyperpigmentation and UV-damage. This pilot study will determine skin characteristics after intervention with north atlantic fish oil.
Read the detailed description
Women will be recruited to a placebo or fish oil group and be examined at pre- and post for skin quality parameters such as wrinkles, fine lines and trans-epithelial water loss.
- Conditions
- Skin Health
- Being tested
- Placebo, Ceto 10
- Keywords
- skin, inflammation, wrinkles, trans epithelial water loss, fish oil, LCMUFA
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
1g corn oil capsules
Ceto 10Dietary supplement
1g capsules containing oil broad spectrum marine oil from north atlantic fish
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 4x1g corn oil capsules Receives: Dietary Supplement: Placebo |
| Ceto 10 | Experimental | 4x1g capsules containing containing broad spectrum marine oil from north atlantic fish Receives: Dietary Supplement: Ceto 10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the change in skin quality of healthy women after supplementation with fish oil compared to corn oil
Changes in quantitative analysis of facial inflammation, wrinkles and fine lines and skin texture will be performed using the VISIA Skin Analysis system. Measurements will be made at baseline and at end of supplementation period.
Measured: 3 months
Secondary outcomes (1)
Determine the change in omega-3 index (%EPA and DHA in red blood cells) after daily intake of 4g of north atlantic fish oil compared to placebo
Fatty acid profiles will be measured from blood samples using the Omega-quant test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start23 Aug 2021
- Primary completion20 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies 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
- Model description
- Placebo controlled, double blind intervention study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epax Norway AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Møreforsking AS
- Responsible party
- Sponsor
- Investigators
- Lisa Midtbø, PhD, Principal investigator, Møreforsking AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128240
- Sponsor's protocol ID
- P237921
- Acronym
- OPTIHUD
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be presented as collective statistical data. Individual participant data may be shared on request, or if demanded by journals
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Two-armed, Double-blinded Nutritional Study of Fish Oil on Skin Quality in Healthy Women
- ClinicalTrials.gov ID
- NCT05128240
- Acronym / sponsor ID
- OPTIHUD / P237921
- Conditions
- Skin Health
- Keywords
- skin, inflammation, wrinkles, trans epithelial water loss, fish oil, LCMUFA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Epax Norway ASIndustry (pharma, biotech, devices)
- Collaborators
- Møreforsking AS
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 19 Nov 2021 (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 skin acts as a barrier against the external environment and prevents water loss from the body. Aging is a natural process leading to changes in the skin and fish oil has been shown to prevent inflammation, hyperpigmentation and UV-damage. This pilot study will determine skin characteristics after intervention with north atlantic fish oil.
Detailed description
Women will be recruited to a placebo or fish oil group and be examined at pre- and post for skin quality parameters such as wrinkles, fine lines and trans-epithelial water loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo controlled, double blind intervention study.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo4x1g corn oil capsules |
| Ceto 10 | Experimental | Dietary Supplement: Ceto 104x1g capsules containing containing broad spectrum marine oil from north atlantic fish |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy women in the age of 30-65
- Able to follow the following dietary restriction for 4 months (4 weeks wash-out, 3 months intervention):
- Do not take omega-3 supplements
- do not take supplements containing vitamin A
- do not take supplements containing collagen
Key exclusion criteria (2 listed)
- Pregnancy or breast feeding known allergy to seafood skin treatment the last 6 months planned skin treatment during the study period
- -
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 |
|---|---|---|
| Placebo1g corn oil capsules | Dietary supplement | Placebo |
| Ceto 101g capsules containing oil broad spectrum marine oil from north atlantic fish | Dietary supplement | Ceto 10 |
Primary outcome
Determine the change in skin quality of healthy women after supplementation with fish oil compared to corn oil
Time frame: 3 months
Changes in quantitative analysis of facial inflammation, wrinkles and fine lines and skin texture will be performed using the VISIA Skin Analysis system. Measurements will be made at baseline and at end of supplementation period.
1 secondary outcome
Determine the change in omega-3 index (%EPA and DHA in red blood cells) after daily intake of 4g of north atlantic fish oil compared to placebo
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: No. Data will be presented as collective statistical data. Individual participant data may be shared on request, or if demanded by journals
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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.
Derek Tobin, PhD contact
Lisa Midtbø, PhD principal investigator
Møreforsking AS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ceto 10 in people with Skin Health, run by Epax Norway AS at 1 site in Norway.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Nov 2021. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Derek Tobin, PhD (derek.tobin@pelagia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the change in skin quality of healthy women after supplementation with fish oil compared to corn oil (time frame: 3 months). 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 19 Nov 2021.