Study to Investigate the Effect of Superba Boost on the Skin

NCT05711303 | 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 reduction in Trans-Epidermal Water-Loss (TEWL).

Conditions

Trans-epidermal Water Loss

Outcome Measures

Primary Outcomes (1)

• To determine the effect of 12 weeks daily consumption of Superba Boost as compared to placebo on reduction in Trans-Epidermal Water-Loss (TEWL).

  Reduction in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of intervention using a TEWAMetre.

  12 weeks.

Secondary Outcomes (8)

• To determine the effect of daily consumption of Superba Boost as compared to placebo on the reduction of Trans-epidermal water loss (TEWL),

  6 weeks.

• To assess the effect of daily consumption of Superba Boost as compared to placebo on changes in skin hydration

  6 week

• To assess the effect of daily consumption of Superba Boost as compared to placebo on changes in skin hydration

  6 weeks

• To assess the effect of daily consumption of Superba Boost as compared to placebo on changes in skin firmness (6 weeks)

  6 weeks

• To assess the effect of daily consumption of Superba Boost as compared to placebo on changes in skin firmness

  6 weeks

Other Outcomes (1)

• To determine the effect of Superba Boost versus the placebo on the Lipid content of skin (Exploratory)

  12 weeks

Study Arms (2)

Superba Boost

ACTIVE COMPARATOR

One 1000 mg capsule per day Superba Boost for 12 weeks

Dietary Supplement: Superba Boost

Placebo

PLACEBO COMPARATOR

One 1000 mg capsule per day placebo for 12 weeks

Dietary Supplement: Superba Boost

Interventions

Superba Boost DIETARY_SUPPLEMENT

To assess changes in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of intervention using a TEWAMetre.

Also known as: Placebo

Placebo; Superba Boost

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

• Atlantia Food Clinical Trials: lead

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Munster, T23 R50R, Ireland

Location

Study Officials

• Sally O'Shea, MD

  Atlantia Food Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, 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: June 25, 2019
• First Posted: February 3, 2023
• Study Start: March 13, 2019
• Primary Completion: August 12, 2019
• Study Completion: December 20, 2019
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)