Physiology, SkinNCT04013945
Study to Investigate the Effect of Superba Boost on the Skin.
A study testing Superba Boost (Active) in people with Physiology, Skin, run by Aker BioMarine Human Ingredients AS at 1 site in Ireland.
Trial summary
Study to determine the effect of 12 weeks daily consumption of Superba Boost as compared to placebo on changes in Trans-Epidermal Water-Loss (TEWL). Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiology, Skin
- What is being tested?
- Superba Boost (Active)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIreland
- Study dates
- 13 Mar 2019to 22 Mar 2020
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be eligible for inclusion, the subject must fulfil all of the following criteria:
- Be able to give written informed consent;
- Be aged between 20 and 50 years, inclusive;
- Trans-epidermal water loss score >10 and ≤ 24.9 g/m²/h;
- Be in general good health with no existing co-morbidities
- Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less;
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- Be willing to avoid all fish and seafood meals in the 4-days before each scheduled clinic visit;
- Be willing to maintain dietary habits and physical activity levels throughout the trial period;
- Be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator;
- Willing \& able to consume the investigational product daily for the duration of the study.
Who cannot join
- The presence of any of the following criteria will exclude the subject from participating in the study:
- Pregnant or breastfeeding women; women planning to become pregnant during the study;
- Women of child-bearing potential who do not use an acceptable method of contraception;
- Suffer from photosensitivity;
- History of skin cancer;
- Are currently taking photosensitizing medication, or have done so in the previous 4 weeks;
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- Sunbed tanning or sunbathing in preceding 3 months, or planned sunbed tanning or sunbathing during the study period
- Taking supplements known to have an effect on skin (e.g. fish oil, coenzyme Q-10, garlic, lycopene, beta-carotene, etc.), or have done so in the previous 4 weeks, except for medically-prescribed supplements or natural health products.
- Supplements known not to have an effect on the skin (e.g. probiotics) are allowed, once the subject has been on a stable dose for greater than 3 months and are willing to continue this supplement for the duration of the study;
- Systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg. Subjects receiving blood pressure medications, must be on stable dose for greater than 3 months;
- Known allergy to seafood;
- Are hypersensitive to any of the components of the test product;
- Disturbed absorption due to changes in the gastrointestinal tract (e.g., resections, diverticula, malabsorption, blind-loop syndrome);
- Known alcohol abuse (> 21 units of alcohol per week) or drug abuse within the previous year of screening;
- Clinically significant illness within 14 days prior to dosing;
- Current or recent (within 3 months of screening visit) changes in diet, which in the opinion of the Investigator, deviates from a normal diet (e.g. vegetarians may be acceptable, vegans are not acceptable);
- Planned major changes in life style (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
- Has any health conditions that would prevent from fulfilling the study requirements, put the subject at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results;
- Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year);
- Experiences alarm features such as weight loss, rectal bleeding, recent change in bowel habit (<3 months) or abdominal pain;
- Have a malignant disease or any concomitant end-stage organ disease;
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;
- Subjects receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blinded, Parallel, Placebo-controlled Study to Investigate the Effect of Superba Boost (Krill Oil Concentrate) on Various Skin Parameters in Healthy Adult Subjects.
Study to determine the effect of 12 weeks daily consumption of Superba Boost as compared to placebo on changes in Trans-Epidermal Water-Loss (TEWL).
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, parallel group trial in 70 healthy adult male and female subjects between 20 and 50 years. The primary objective is to assess whether Superba Boost krill oil administered at a dose of 1 g per day for 12 weeks (84 days) has a positive effect on the TEWL, skin hydration and elasticity. At screening, the subjects must have TEWL values of >10 g/m2/h and <24.9 g/m2/h when measured by a TEWAmeter, i.e. within the range defined as normal and healthy skin. The change in omega-3 index, defined as EPA and DHA as percentage of total fatty acids in red blood cells, will be measured and correlated to the changes in the skin parameters.
The study consists of 4 visits: the screening visit (V1), baseline visit / week 0 / Start of treatment (V2), Interim / Week 6 (V3) and week 12 / end of treatment (V4) . In this study, subjects must have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less will be recruited. Each subject must fulfill all inclusion criteria and will not be allowed to meet any of the exclusion criteria.
- Conditions
- Physiology, Skin
- Being tested
- Superba Boost (Active), Vegetable oil (Placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superba Boost (Active)Dietary supplement
To assess changes in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of daily consumption with Superba Boost.
Vegetable oil (Placebo)Dietary supplement
To assess changes in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of daily consumption with Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Superba Boost capsules | Active comparator | 1000 mg krill oil concentrate per capsule Receives: Dietary Supplement: Superba Boost (Active) |
| Placebo capsules | Placebo comparator | 1000 mg capsule composed of mixed vegetable oil. Receives: Dietary Supplement: Vegetable oil (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 weeks daily consumption of Superba Boost as compared to placebo on changes in Trans-Epidermal Water-Loss (TEWL) will be measured.
Trans-epidermal water loss (the loss of water that passes from inside the body through the skin to outside the body) measured at baseline and after 12 weeks of intervention using a TEWAMetre will be considered. This measurement provides information on the integrity of the skin protective barrier functions. Subjects eligible for the study will have a TEWL value >10 and ≤ 24.9 g/m²/h. In comparison, A TEWL value between 0-9 is classified as a "very healthy" barrier function and values between 25-34 are in the "strained" range. These participants will therefore be deemed ineligible for the study. Additionally, subjects with a TEWL value of >35 will have a skin barrier function classified as "critical" and will also be ineligible for the study.
Measured: 12 weeks.
Secondary outcomes (5)
Daily consumption of Superba Boost as compared to placebo on changes of in TEWL values.
The effect of daily consumption of Superba Boost as compared to placebo on changes in Trans-Epidermal Water-Loss (TEWL) from baseline to 6 weeks after start of treatment, and from 6 weeks of treatment to the end-of-study will be measured.
Measured: 12 weeks.
The effect of daily consumption of Superba Boost as compared to placebo on changes in skin hydration will be measured.
The effect of daily consumption of Superba Boost as compared to placebo on changes in skin hydration from baseline (pre-study) to 6 weeks after start of treatment, and from 6 weeks of treatment until end-of-study will be considered. The Corneometer indicates the hydration level of the top layers of the skin. The value of the dielectric constant is directly proportional to the level of skin hydration. i.e. higher value= more hydrated skin. The measurements for skin hydration are as follows: 0-29.9 (Very Dry), 30-44.9 (Dry), 44-130 (Normal).
Measured: 12 weeks.
The effect of daily consumption of Superba Boost as compared to placebo on changes in skin firmness will be measured.
The effect of daily consumption of Superba Boost as compared to placebo on changes in skin firmness from baseline (pre-study) to 6 weeks after start of treatment, and from 6 weeks of treatment until end-of-study will be considered. The Cutometer measures the resistance of the skin to be sucked up by negative pressure (firmness) and its ability to return into its original position (elasticity). Elasticity is measured from 0 (no elasticity) to 1 (maximum elasticity).
Measured: 12 weeks.
The effect of daily consumption of Superba Boost as compared to placebo on subjective evaluation by study subjects, using questionnaires will be studied.
The effect of daily consumption of Superba Boost as compared to placebo on subjective evaluation by study subjects, using questionnaires, after 6 and 12 weeks of treatment will be considered. Subjects will be provided with a "Subject Skin Evaluation" Questionnaire and will answer questions regarding "Overall Skin Condition", "Skin Hydration", "Skin Moisture" and "Skin Elasticity and Firmness" of their own skin. Changes in the subjects' interpretation of their own skin condition will therefore be reported over the 12-week study period.
Each subject reports their opinion of their own skin condition through a numeric scale measuring from 0 to 100mm. 0mm is the "worst" skin condition and 100mm is the "best".
Measured: 12 weeks.
The effect of daily consumption of Superba Boost as compared to placebo on Omega-3 index will be measured.
The effect of daily consumption of Superba Boost as compared to placebo on Omega-3 index, using a blood spot collected by fingerpick will be considered. The higher the percentage (%), the higher the Omega-3 content of the blood.
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start13 Mar 2019
- Primary completion12 Aug 2019
- Study completion22 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiology, SkinStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects who successfully meet the eligibility criteria will be randomized on a 1:1 basis, to receive Superba Boost or Placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aker BioMarine Human Ingredients AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Aoife Hayes, PhD, Study director, Atlantia Food Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013945
- Sponsor's protocol ID
- AFCRO-097
- Status last verified
- Jan 2023
- First submitted
- 6 Jul 2019
- Last updated
- 1 Feb 2023
- 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blinded, Parallel, Placebo-controlled Study to Investigate the Effect of Superba Boost (Krill Oil Concentrate) on Various Skin Parameters in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT04013945
- Acronym / sponsor ID
- AFCRO-097
- Conditions
- Physiology, Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aker BioMarine Human Ingredients ASIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 22 Mar 2020 (actual)
- First posted
- 10 Jul 2019 (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.
Study to determine the effect of 12 weeks daily consumption of Superba Boost as compared to placebo on changes in Trans-Epidermal Water-Loss (TEWL).
Detailed description
This study is a randomized, double-blind, placebo-controlled, parallel group trial in 70 healthy adult male and female subjects between 20 and 50 years. The primary objective is to assess whether Superba Boost krill oil administered at a dose of 1 g per day for 12 weeks (84 days) has a positive effect on the TEWL, skin hydration and elasticity. At screening, the subjects must have TEWL values of >10 g/m2/h and <24.9 g/m2/h when measured by a TEWAmeter, i.e. within the range defined as normal and healthy skin. The change in omega-3 index, defined as EPA and DHA as percentage of total fatty acids in red blood cells, will be measured and correlated to the changes in the skin parameters.
The study consists of 4 visits: the screening visit (V1), baseline visit / week 0 / Start of treatment (V2), Interim / Week 6 (V3) and week 12 / end of treatment (V4) . In this study, subjects must have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less will be recruited. Each subject must fulfill all inclusion criteria and will not be allowed to meet any of the exclusion criteria.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects who successfully meet the eligibility criteria will be randomized on a 1:1 basis, to receive Superba Boost or Placebo.
| Arm | Type | Receives |
|---|---|---|
| Superba Boost capsules | Active comparator | Dietary Supplement: Superba Boost (Active)1000 mg krill oil concentrate per capsule |
| Placebo capsules | Placebo comparator | Dietary Supplement: Vegetable oil (Placebo)1000 mg capsule composed of mixed vegetable oil. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Be able to give written informed consent;
- Be aged between 20 and 50 years, inclusive;
- Trans-epidermal water loss score >10 and ≤ 24.9 g/m²/h;
- Be in general good health with no existing co-morbidities
- Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less;
Key exclusion criteria (23 listed)
- The presence of any of the following criteria will exclude the subject from participating in the study:
- Pregnant or breastfeeding women; women planning to become pregnant during the study;
- Women of child-bearing potential who do not use an acceptable method of contraception;
- Suffer from photosensitivity;
- History of skin cancer;
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 |
|---|---|---|
| Superba Boost (Active)To assess changes in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of daily consumption with Superba Boost. | Dietary supplement | Superba Boost capsules |
| Vegetable oil (Placebo)To assess changes in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of daily consumption with Placebo. | Dietary supplement | Placebo capsules |
Primary outcome
12 weeks daily consumption of Superba Boost as compared to placebo on changes in Trans-Epidermal Water-Loss (TEWL) will be measured.
Time frame: 12 weeks.
Trans-epidermal water loss (the loss of water that passes from inside the body through the skin to outside the body) measured at baseline and after 12 weeks of intervention using a TEWAMetre will be considered. This measurement provides information on the integrity of the skin protective barrier functions. Subjects eligible for the study will have a TEWL value >10 and ≤ 24.9 g/m²/h. In comparison, A TEWL value between 0-9 is classified as a "very healthy" barrier function and values between 25-34 are in the "strained" range. These participants will therefore be deemed ineligible for the study. Additionally, subjects with a TEWL value of >35 will have a skin barrier function classified as "critical" and will also be ineligible for the study.
5 secondary outcomes
Daily consumption of Superba Boost as compared to placebo on changes of in TEWL values.
Time frame: 12 weeks.
The effect of daily consumption of Superba Boost as compared to placebo on changes in skin hydration will be measured.
Time frame: 12 weeks.
The effect of daily consumption of Superba Boost as compared to placebo on changes in skin firmness will be measured.
Time frame: 12 weeks.
The effect of daily consumption of Superba Boost as compared to placebo on subjective evaluation by study subjects, using questionnaires will be studied.
Time frame: 12 weeks.
The effect of daily consumption of Superba Boost as compared to placebo on Omega-3 index will be measured.
Time frame: 12 weeks.
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 1 Feb 2023.
- 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.
Aoife Hayes, PhD study director
Atlantia Food Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superba Boost (Active) in people with Physiology, Skin, run by Aker BioMarine Human Ingredients AS at 1 site in Ireland.
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 10 inclusion and 23 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 1 Feb 2023. 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 Ireland. 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?
12 weeks daily consumption of Superba Boost as compared to placebo on changes in Trans-Epidermal Water-Loss (TEWL) will be measured. (time frame: 12 weeks.). 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 1 Feb 2023.