Study to Investigate the Effect of Superba Boost on the Skin.

NCT04013945 | Completed

• 1 other identifier: AFCRO-097
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Physiology, Skin

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks.

Secondary Outcomes (5)

• Daily consumption of Superba Boost as compared to placebo on changes of in TEWL values.

  12 weeks.

• The effect of daily consumption of Superba Boost as compared to placebo on changes in skin hydration will be measured.

  12 weeks.

• The effect of daily consumption of Superba Boost as compared to placebo on changes in skin firmness will be 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.

  12 weeks.

• The effect of daily consumption of Superba Boost as compared to placebo on Omega-3 index will be measured.

  12 weeks.

Other Outcomes (1)

• Depending on the outcome of the primary and secondary objectives, further exploratory analysis may be performed on the skin samples to meaure the effect of Superba Boost versus the placebo on the Lipid content of skin

  12 weeks.

Study Arms (2)

Superba Boost capsules

ACTIVE COMPARATOR

1000 mg krill oil concentrate per capsule

Dietary Supplement: Superba Boost (Active)

Placebo capsules

PLACEBO COMPARATOR

1000 mg capsule composed of mixed vegetable oil.

Dietary Supplement: Vegetable oil (Placebo)

Interventions

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.

Superba Boost capsules

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.

Placebo capsules

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Aker BioMarine Human Ingredients AS: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food CRO

Cork, Munster, T23R50R, Ireland

Location

MeSH Terms

Interventions

Exercise; Plant Oils

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Aoife Hayes, PhD

  Atlantia Food Clinical Trials

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be carried out by computer-generated block-randomization lists. Subjects will be randomized to one of the two treatment groups, in blocks of 6. The randomization will be seeded, with the seed only available to the statistician generating the randomization list.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects who successfully meet the eligibility criteria will be randomized on a 1:1 basis, to receive Superba Boost or Placebo.

Study Record Dates

• First Submitted: July 6, 2019
• First Posted: July 10, 2019
• Study Start: March 13, 2019
• Primary Completion: August 12, 2019
• Study Completion: March 22, 2020
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)