UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034129 |
|---|---|
| Receipt number | R000038909 |
| Scientific Title | Efficacy trial of continuous ingestion of plant derived ingredients. [trial number g2018006] |
| Date of disclosure of the study information | 2018/09/20 |
| Last modified on | 2019/08/21 16:56:32 |
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Basic information
Public title
Efficacy trial of continuous ingestion of plant derived ingredients. [trial number g2018006]
Acronym
Efficacy of plant derived ingredients. [trial number g2018006]
Scientific Title
Efficacy trial of continuous ingestion of plant derived ingredients. [trial number g2018006]
Scientific Title:Acronym
Efficacy of plant derived ingredients. [trial number g2018006]
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 continuous ingestion of plant derived ingredients for 4 weeks on glucose metabolism in healthy adults with high normaland impaired fasting glucose
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose
Key secondary outcomes
Insulin, glucagon, 1.5-AG, glycol-albumin, gastrointestinal hormone, triglyceride, free fatty acids, apo B48, ketone body, body weight, body fat ratio, appetite (questionnaire)
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
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Control food A, once daily,
continuous ingestion for 4 weeks
Interventions/Control_2
Test food B, once daily,
continuous ingestion 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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Healthy male adults aged 20 and older, under 65
(2) Subjects with fasting glucose ranged 100 mg/dL and more, less than126 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, or taking drugs related diabetes
(2)Subjects who have history or symptom of cardiovascular disease or cerebrovascular disease
(3)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
(4)Subjects who have a history of resection of gastrointestinal tract, excluding cecal resection surgery
(5)Heavy drinker (over 30g alcohol per day)
(6)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
(7)Subjects who have severe anemia (Hb <=7g/dL)
(8)Subjects who have food allergies for test foods
(9)Subjects who plan to participate in other clinical study during the current study
(10)Subjects who are judged to be inappropriate for the study by the medical doctor or investigator for other reasons
Target sample size
30
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 | 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
Homepage URL
hibi.masanobu@kao.com
Sponsor or person
Institute
Clinical Support 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
Medical corporation Hokubukai Utsukushigaoka Hospital IRB
Address
61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
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
医療法人社団翔嶺館新札幌聖陵ホスピタル（北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 20 | 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
30
Results
No significant difference in the primary outcome
Results date posted
| 2019 | Year | 08 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adults with high normal and impaired fasting glucose
Participant flow
30 participants completed
Adverse events
No adverse effect related to the test diets reported
Outcome measures
Glucose
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 14 | Day |
Last modified on
| 2019 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038909
