UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014533
Receipt No. 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 (Ver. 13)

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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
Email 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
Email t.tamura@tes-h.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016885