UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014533 |
|---|---|
| Receipt number | R000016885 |
| Scientific Title | Study on effects of a plant-derived protein containing food product on postprandial hyperglycemia |
| Date of disclosure of the study information | 2014/07/15 |
| Last modified on | 2019/07/25 13:29:55 |
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Basic information
Public title
Study on effects of a plant-derived protein containing food product on postprandial hyperglycemia
Acronym
Study on effects of a plant-derived protein containing food product on postprandial hyperglycemia
Scientific Title
Study on effects of a plant-derived protein containing food product on postprandial hyperglycemia
Scientific Title:Acronym
Study on effects of a plant-derived protein containing food product on postprandial hyperglycemia
Region
| Japan |
Condition
Condition
Postprandial hyperglycemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of a food product on postprandial hyperglycemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postprandial blood glucose
Key secondary outcomes
Insulin, TG, GIP, GLP-1, ghrelin, appetite (satiety)
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
placebo food
Interventions/Control_2
active 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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1, Fasting blood glucose > 94, and <126 mg/dL
2, HbA1c (NGSP) > 5.1, and <6.5
3, Aged between 30 and 59
4, BMI >22.9 and <30 kg/m2
5, Person who can accept to be accessed their medical records and agree with the study protocol followed by a prior explanation
6, Person who provides informed consent by a document
7, Depends on the screening condition of above 1 to 3 criteria, person who does not meet the criteria can be screened in case that the physican in charge, the client and the CRO reach to agreement of it.
Key exclusion criteria
1, Person who is difficult to participate the study due to dysfunctions of liver, kidney, heart, respiration, endocrine secretion, metabolism, nervous system, consciousness or diabetes, or the other dysfunctions
2, Person who was given surgery for a disease or an injury 2 months prior to the study
3, Person who was given gastrectomy and/or bypass of part of the intestine
4, Person who takes medication for glucose or fat metabolism, or hypertension
5, Person who habitually consumes the foods for specific health use (FOSHU) and/or dietary supplements (capsules) (except for person who can stop to consume them right after informed consent)
6, Person who is or had been given treatment for allergies to test food ingredients
7, Person who has been ill due to blood collecting
8, Person who donated 200mL or more of blood within a month prior to the study
9, Person who skip breakfast habitually
10, Heavy smoker or person who cannot stop
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Saito |
Organization
Kao Corporation
Division name
Health Care Food Research Labs.
Zip code
131-8501
Address
2-1-3 Bunka Sumida-ku Tokyo
TEL
03-5630-7456
saito.shinichiro@kao.co.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Tamura |
Organization
TES Holdings Co. Ltd
Division name
Sales department for tissue engineering and clinical research
Zip code
103-0027
Address
Tokyo Univ 6F, 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-6801-8480
Homepage URL
t.tamura@tes-h.co.jp
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
the Ethical Committee of the Oriental Ueno Kenshin Center
Address
1-20-11 Ueno, Taito-ku, Tokyo
Tel
03-5816-0711
ueno-center@oriental-gr.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 相生会 墨田病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 15 | 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
https://www.mdpi.com/2072-6643/11/1/187
Number of participants that the trial has enrolled
20
Results
There was a significantly difference in the primary outcome between the groups
Results date posted
| 2019 | Year | 07 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy men
Participant flow
22 were screened and 20 were analyzed
Adverse events
No adverse events occurred associated with consumption of the test diets
Outcome measures
Postprandial blood glucose
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 11 | Day |
Last modified on
| 2019 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016885
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