Status:
COMPLETED
Study to Investigate the Effect of Superba Boost on the Skin.
Lead Sponsor:
Aker BioMarine Human Ingredients AS
Collaborating Sponsors:
Atlantia Food Clinical Trials
Conditions:
Physiology, Skin
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief 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).
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 Supe...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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;
- 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.
- Exclusion:
- 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;
- 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.
Exclusion
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04013945
Start Date
March 13 2019
End Date
March 22 2020
Last Update
February 1 2023
Active Locations (1)
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1
Atlantia Food CRO
Cork, Munster, Ireland, T23R50R