UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032373 |
|---|---|
| Receipt number | R000036889 |
| Scientific Title | Efficacy trial of single intake of plant derived ingredient. [g2018002] |
| Date of disclosure of the study information | 2018/04/26 |
| Last modified on | 2022/04/13 13:05:16 |
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Basic information
Public title
Efficacy trial of single intake of plant derived ingredient. [g2018002]
Acronym
Efficacy of plant derived ingredient. [g2018002]
Scientific Title
Efficacy trial of single intake of plant derived ingredient. [g2018002]
Scientific Title:Acronym
Efficacy of plant derived ingredient. [g2018002]
Region
| Japan |
Condition
Condition
Adults with high normal and impaired fasting glucose (fasting plasma glucose, 100-125 mg/dl)
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 glucose metabolism in adults with high normal and impaired fasting glucose.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dose-response assessment based on concentration of gastrointestinal hormone(tAUC, iAUC, C-max).
Key secondary outcomes
Dose-response assessment based on concentration of insulin and glucose(tAUC, iAUC, C-max).
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
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Control food consumption > wash out (1 week) > test food A consumption > wash out (1 week) > test food B consumption > wash out (1 week) > test food C consumption
Interventions/Control_2
test food A consumption > wash out (1 week) > test food B consumption > wash out (1 week) > test food C consumption > wash out (1 week) > Control food consumption
Interventions/Control_3
test food B consumption > wash out (1 week) > test food C consumption > wash out (1 week) > Control food consumption > wash out (1 week) > test food A consumption
Interventions/Control_4
test food C consumption > wash out (1 week) > Control food consumption > wash out (1 week) > test food A consumption > wash out (1 week) > test food B consumption
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
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
(1)Adult aged from 20 y to 65 y
(2)Subjects with fasting glucose from 100 to 125 mg/dL
(3)Subjects can consume test foods, and record life diaries and meal diaries
(4)Subjects who have given written informed consent prior to study.
Key exclusion criteria
(1)Subjects diagnosed with diabetes mellitus
(2)Subjects taking drug related diabetes mellitus
(3)Subjects who have history or symptom of cardiovascular disease or cerebrovascular disease
(4)Subjects who have symptom 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
(5)Subjects who have a history of resection of gastrointestinal tract
(6)Subjects having thyroid deficiency
(7)Heavy drinker (over 30g per day)
(8)Subjects who have donated over 200 mL of blood within the last one month prior to the current study or over 400 mL of blood within the last three months prior to the study
(9)Subjects who have severe anemia (Hb <=7g/dL)
(10)Subjects who have food allergies for test foods
(11)Subjects who are planned to participate in other clinical study during current study
(12)Subjects who are judged to be inappropriate for the study by the medical doctor or investigator for other reason
Target sample size
18
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, 131-8501, Japan
TEL
03-5630-7266
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, 131-8501, Japan
TEL
03-5630-7266
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
Hokubukai Utsukushigaoka Hospital Ethics Committee
Address
61-1, Shinei, Kiyota-ku, Sapporo-shi, Hokkaido
Tel
011-882-0111
wakimoto@ughp-cpc.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
| 2018 | Year | 04 | Month | 26 | 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
18
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
Adults with high normal and impaired fasting glucose (fasting plasma glucose, 100-125 mg/dl)
Participant flow
16 participants completed and 16 subjects were incorporated into the analyses (2 participants were discontinued due to untraceable)
Adverse events
none
Outcome measures
gastrointestinal hormone
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 25 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 25 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 25 | 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=R000036889
