UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041485 |
|---|---|
| Receipt number | R000047365 |
| Scientific Title | Efficacy trial of ingestion of plant derived ingredient. [g2020004(KO22)] |
| Date of disclosure of the study information | 2020/08/21 |
| Last modified on | 2022/04/13 14:52:31 |
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Basic information
Public title
Efficacy trial of ingestion of plant derived ingredient. [g2020004(KO22)]
Acronym
Efficacy of plant derived ingredient [g2019004]
Scientific Title
Efficacy trial of ingestion of plant derived ingredient. [g2020004(KO22)]
Scientific Title:Acronym
Efficacy of plant derived ingredient [g2019004]
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of a plant derived ingredient on blood glucose in healthy male adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of blood glucose
Key secondary outcomes
Concentration of blood insulin, GLP-1, and GIP
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
4 weeks consumption of control food > wash out (4 weeks) > 4 weeks consumption of test food
Interventions/Control_2
4 weeks consumption of test food > wash out (4 weeks) > 4 weeks consumption of control food
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Adult aged from 20 y to 60 y
(2) Fasting glucose from 70 to 125 mg/dL
Key exclusion criteria
(1) Diabetes mellitus
(2) Taking medicine related diabetes mellitus
(3) BMI>=30kg/m2
(4) Blood triglyceride>=150mg/dL
(5) Taking antihypertensive
(6) Having history or presence of cardiovascular disease or cerebrovascular disease
(7) Presence of liver, kidney or respiratory disease, endocrine disorder, metabolic disorder, organ disorder, gout, rheumatism, autoimmune disease, allergy disease, mental disorder, cancer, infection disease, or other diseases
(8) Having history of resection of gastrointestinal tract
(9) Thyroid deficiency
(10) Heavy alcohol drinker (over 30g per day)
(11) Donated over 200 mL of blood within the last one month prior to the study or over 400 mL of blood within the last three months prior to the study or severe anemia
(12) Having felt sick during blood collection
(13) Food allergies for test foods or lactose intolerance
(14) Tape allergy
(15) Caffeine hypersensitivity
(16) Planned to participate in other clinical study during current study
(17) Shift worker
(18) Planned to be examined by X-ray, CT, or MRI
(19) Using an implantable medical device such as a pacemaker
(20) Undergoing artificial dialysis
(21) Within the last 2 weeks, having flu symptoms such as fever, cough, or sore throat, high fever, dyspnea, strong malaise, taste disorders, or olfactory disorders
(22) Within the last 2 weeks, having family members or friends infected with COVID-19 or having close contact with infected person
(23) Having overseas travel history within 1 month
(24) Determined to be unqualified by the physician in charge or the responsible person of the study
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Hibi |
Organization
Kao Corporation
Division name
Biological Science Research laboratories
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, Japan
TEL
03-5630-7476
hibi.masanobu@kao.com
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Yanagimoto |
Organization
Kao Corporation
Division name
Biological Science Research laboratories
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, Japan
TEL
03-5630-7476
Homepage URL
yanagimoto.aya@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Ueno-Asagao Clinic Ethical Review Committee
Address
Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, Japan
Tel
03-6240-1162
jimukyoku@tes-h.co.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
| 2020 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Published
Result
URL related to results and publications
works in progress
Number of participants that the trial has enrolled
16
Results
A significant difference was observed in the primary outcome.
Results date posted
| 2022 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adults
Participant flow
14 participants completed and 16 subjects were incorporated into the analyses (1 subject was discontinued due to cold symptoms and 1 subject was unable to contact)
Adverse events
One subject stopped participating due to cold symptoms, and then confirmed complete recovery.
Outcome measures
Concentration of blood glucose
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 16 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047365
