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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000045734
Receipt No. R000052210
Scientific Title Effects of the Consumption of Superba Boost(R) on barrier function of skin through TEWL in healthy individuals: A Randomized Double Blind Placebo Controlled Trial
Date of disclosure of the study information 2021/10/12
Last modified on 2021/10/18

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Basic information
Public title Effects of the Consumption of Superba Boost(R) on barrier function of skin through TEWL in healthy individuals
Acronym Effects of the Consumption of Superba Boost(R) on barrier function of skin through TEWL in healthy individuals
Scientific Title Effects of the Consumption of Superba Boost(R) on barrier function of skin through TEWL in healthy individuals: A Randomized Double Blind Placebo Controlled Trial
Scientific Title:Acronym Effects of the Consumption of Superba Boost(R) on barrier function of skin through TEWL in healthy individuals
Region
Japan

Condition
Condition Healthy Japanese subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main objective of this trial is to investigate the effects of a 12-week, continuous daily consumption of Superba Boost(R) capsules on barrier properties of skin evaluated by TEWL in healthy Japanese adults with normal to slightly dried skin (TEWL between 15-30 g/h/m2).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Change in TEWL on the right inner forearm, measured at week 0 (baseline) and week 12 after intervention using a TEWAMeter
Key secondary outcomes 1. Changes in TEWL on the right inner arm, measured at week 0 (baseline) and week 6 after intervention using a TEWAMeter

2. Changes in TEWL on the right inner arm, measured at week 6 after intervention and week 12 after intervention using a TEWAMeter

3. Change in skin hydration on the right inner forearm measured using a Corneometer ,from week 0 (baseline) to week 6 after intervention, and that from week 0 (baseline) to week 12 after intervention

4. Change in skin firmness (viscoelasticity) on the right inner forearm measured using a Cutometer from week 0 (baseline) to week 6 after intervention, and from week 0 (baseline) to week 12 after intervention

5. Change in subjective evaluation of skin symptoms by study participants, measured with a VAS scale and a Likert scale, from week 0 (baseline) to week 6 after intervention, and from week 0 (baseline) to week 12 after intervention

6. Change in Omega-3 index, using a blood spot collected by fingerpick measured from week 0 (baseline) to week 12 after intervention

7. Change in Microscopic examination; water/moisture comparison, Pores, Melanin/Freckles, Wrinkles, Porphyrin/sebum, Epidermis, from week 0 (baseline) to week 12 after intervention

*Viscoelasticity is reflected by the ratio of degree of immediate retraction to that of the total skin deformation (R7) obtained from the graph produced when measuring with the Cutometer. This is also known as the portion of the elasticity compared to the complete curve.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 12 weeks
Test food: Superba Boost(R)
Administration: Participants will be instructed to take two oral capsules of 1000 mg Superba Boost(R) once per day at breakfast

* If a dose is missed, they should take it as soon as possible within the day.
Interventions/Control_2 Duration: 12 weeks
Test food: A mixture of vegetable oil
Administration:Participants will be instructed to take two oral capsules of 1000 mg placebo once per day at breakfast

* If a dose is missed, they should take it as soon as possible within the day.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Japanese male and female

2. 30-65 years of age inclusive

3. Healthy individual (Be in general good health with no existing co-morbidities)

4. Individuals who are judged to be eligible for participation by the principal investigator

5. Have a Transepidermal Water Loss (TEWL) Score of their right inner forearm within the range of 15-30 g/m2/h inclusive at screening

6. Have a low habitual consumption of fatty fish (salmon, mackerel, herring and tuna) and food that is high in omega-3 fatty acid, defined as maximum frequency of once per week (Examples of food that is high in omega-3 fatty acid:Blue-backed fishes such as Atlantic mackerel, sardine, and mackerel pike, flaxseed oil, and fish oil)

7. Individuals who are neither overweight nor obese (BMI greater than or equal to 25)
Key exclusion criteria 1. Be undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction

2. Be carrying a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Be undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily diet

5. Have been taking Omega-3 fatty acid supplement 3 months prior to the briefing session

6. Be taking long-term medication (s) (including western medicine such as antiallergic drugs, antihistamines, steroids, vasoconstrictors and Traditional Chinese Medicine) regularly) or supplement (s)

7. Individuals who are allergic to seafood, the test product and/or the test-food-related products in this trial

8. Have no intention of taking the test food with the prescribed amount and ingestion method

9. Individuals who are pregnant, lactating or planning pregnancy during the trial period

10. Participated in other clinical trial(s) 28 days prior to receiving agreement of this trial or planning to participate in other clinical trials during this trial period

11. Received cosmetic surgery in the past

12. Be receiving or undergoing skin medical treatment (e.g. laser treatment, face-lift), skincare treatment (e.g. beauty salon) or use skincare devices (e.g. facial massager) regularly

13. Be diagnosed with atopic dermatitis

14. Be deemed by the principal investigator to be unsuitable for participation
Target sample size 52

Research contact person
Name of lead principal investigator
1st name Tatsuya
Middle name
Last name Izumi
Organization Hiroo Dermatology Clinic & Mentors inc.
Division name Director
Zip code 150-0012
Address 1&2F Hiroo Masugi Annex Bldg., 5-25-5, Hiroo, Shibuya-ku, Tokyo, Japan
TEL 03-5795-1112
Email dr_izumi@orthomedico.jp

Public contact
Name of contact person
1st name Naoko
Middle name
Last name Suzuki
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization AKER BIOMARINE Antarctic ASA
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic

Hiroo Dermatology Clinic & Mentors inc.

Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email IRB@takara-clinic.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2021 Year 09 Month 29 Day
Date of IRB
2021 Year 09 Month 29 Day
Anticipated trial start date
2021 Year 10 Month 18 Day
Last follow-up date
2022 Year 03 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 10 Month 12 Day
Last modified on
2021 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052210

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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