UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050950 |
|---|---|
| Receipt number | R000058004 |
| Scientific Title | Confirmation of skin quality improvement effect of fermented pearl barley jelly intake. |
| Date of disclosure of the study information | 2024/05/10 |
| Last modified on | 2024/03/27 12:15:36 |
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Basic information
Public title
Confirmation of skin quality improvement effect of fermented pearl barley jelly intake in healthy people.
Acronym
Confirmation of skin quality improvement effect of fermented pearl barley jelly intake in healthy people.
Scientific Title
Confirmation of skin quality improvement effect of fermented pearl barley jelly intake.
Scientific Title:Acronym
Confirmation of skin quality improvement effect of fermented pearl barley jelly intake.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of efficacy when ingesting test food for a certain period of time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
･skin condition (equipment measurement, questionnaire) [after 4 weeks of ingestion]
Key secondary outcomes
･skin condition (equipment measurement, questionnaire) [after 1 and 2 and 3 weeks of ingestion]
･Defecation score (property, frequency, amount, questionnaire) [after 1 and 2 and 3 and 4 weeks of ingestion]
･Sleep status, physical condition (stress, fatigue, skin quality, anemia, menstruation) , weight, body fat percentage, blood pressure, pulse [after 1 and 2 and 3 and 4 weeks of ingestion]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest the test food once a day for 4 weeks.
Interventions/Control_2
Ingest the test food once a day for 4 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Healthy Japanese aged 18 to 60 years old when consent acquisition.
(2)Those who don't be given treatment by taking medicines, therapies and/or operations even seasonal, chronic or sudden case.
(3)Those who show enough understanding of the clinical study procedures, and who agree with participating in the study by written informed consent from their own will.
(4)Those whose blood pressure (average from two times measurements) are within the conditions below.
Systolic blood pressure is less or equal 139 mmHg.
Diastolic blood pressure is less or equal 89 mmHg.
(5)Those whose pulses are 40 to 100 times per minute.
(6)Those whose body temperatures are 35.5 to 37.0 degrees Celsius.
(7)Those who basically take 3 meals a day and can prohibit drinking and eating too much.
(8)Those who can contraception properly during test period.
(9)Those who can understand and compliance to controlled matters.
(10)Those who can prohibit the intake of supplements and foods with functional claims.
Key exclusion criteria
(1)Those who have disorder that affect absorption, distribution, metabolism and/or excretion of test food, such as disease in digestive tract, liver, kidney, heart and/or circulation system.
(2)Those who have surgery history in digestive tract such as gastrectomy, gastrointestinal suture surgery and/or intestinal resection etc., but except polypectomy and appendectomy.
(3)Those who have medical history of cerebral vascular disorder.
(4)Those who have specific constitution that occur allergy and/or hypersensitivity against test food.
(5)Those who suspect to alcohol dependence and/or drug dependence.
(6)Those who have attended other clinical trial and/or clinical study within 84 days before consent acquisition.
(7)Those who have done 400mL of whole blood donation within 84 days before consent acquisition. Japanese who have done 200mL of whole blood donation within 28 days before consent acquisition. Japanese who have done 200mL of ingredient donation within 14 days before consent acquisition.
(8)Those who are lactating and/or pregnant.
(9)Those who engage in mid-night work.
(10)Those who have a disease or who are taking medication.
(11)Those who taking contraceptive pills for any purpose.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Nishida |
| Middle name | |
| Last name | Yoshio |
Organization
Tokai Gakuen University
Division name
School of Health and Nutrition
Zip code
468-8514
Address
2-901 Nakahira, Tenpaku-ku, Nagoya-city, Aichi, 468-8514, JAPAN
TEL
052-801-1472
nishid-y@tokaigakuen-u.ac.jp
Public contact
Name of contact person
| 1st name | Asai |
| Middle name | |
| Last name | Noriyuki |
Organization
ICHIBIKI CO., LTD.
Division name
Research Laboratory
Zip code
441-8019
Address
110-2 Kinuta, Hanada-cho, Toyohashi-city, Aichi, 441-8019, JAPAN
TEL
0532-32-8776
Homepage URL
technicalcenter@ichibiki.co.jp
Sponsor or person
Institute
Tokai Gakuen University
Institute
Department
Personal name
Nishida Yoshio
Funding Source
Organization
ICHIBIKI CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai Gakuen University Research Ethics Committee
Address
2-901 Nakahira, Tenpaku-ku, Nagoya-city, Aichi, 468-8514, JAPAN
Tel
052-801-1201
nishid-y@tokaigakuen-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
67
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
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058004
