UMIN-CTR Clinical Trial

Basic information
Public title	Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food.
Acronym	Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food.
Scientific Title	Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food.
Scientific Title:Acronym	Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of suppression of increase in blood glucose level by ingestion of wheat albumin or wheat albumin and carrageen.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	<Efficacy> Area under the curve of blood glucose level from time zero to the 120 minutes. Blood glucose level at the time of blood sampling.
Key secondary outcomes	<Efficacy> Cmax of blood glucose level Tmax of blood glucose level Area under the curve of blood insulin level from time zero to the 120 minutes Cmax of blood insulin level Tmax of blood insulin level

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	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Single intake of Capsules containing wheat albumin
Interventions/Control_2	Single intake of Capsules containing wheat albumin and carrageen
Interventions/Control_3	Single intake of Capsules containing cellulose
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Males and females equal to or more than 20 years and less than 65 years old 2. In the 75g oral glucose tolerance test, subjects with a fasting blood glucose level of 110 mg / dL or more and less than 126 mg / dL or a 2 hour value of 140 mg / dL or more and less than 200 mg / dL. 3. Possible study volunteer to visit 4. Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria	1. Subjects who develop diabetes (Recommended by Japan Diabetes Society). 2. Subjects who have a history of large surgery (gastrectomy,gastrointestinal suture, intestinal resection) on the gastrointestinal except who resect the cecum. 3. Subjects who have marked impairment of heart, liver, kidney, thyroid, and other diseases. 4. Subjects who experienced unpleasant feeling by drawing blood in the past. 5. Subjects who have difficulty drawing blood from the peripheral vein. 6. Subjects who donated 400 ml of blood within 12weeks or component blood donation 200 ml of blood within 4weeks prior to the study. 7. Subjects who are allergic to the test food or who have serious drugs or food allergies. 8. Shift worker and night worker. 9. Subjects whose eating habits are extremely irregular. 10. Heavy drinkers(Average of the amount of pure alcohol per day 40 g or more). 11. Heavy Smokers(More than 21 on average per day) 12. Subjects who are positive for one or more items in the results of virus / immunologic serology examination at the time of prior to the study 13. Pregnant women or breast-feeding women. 14. Subjects who regularly use medicines, health foods, etc. that may affect the study 15. Sujects who was judged ineligibles by clinician in this trial.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Shinpei Middle name Last name Tomita
Organization	New drug research center, Inc.
Division name	General Manager Clinical Research Dept.
Zip code	061-1405
Address	452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL	0123-34-0412
Email	s-tomita@ndrcenter.co.jp

Public contact
Name of contact person	1st name Yoshitaka Middle name Last name Hatakeyama
Organization	New Drug Research Center, Inc.
Division name	Clinical Research Dept.
Zip code	061-1405
Address	452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL	0123-34-0412
Homepage URL
Email	y-hatakeyama@ndrcenter.co.jp

Sponsor
Institute	Nissin Pharma Inc.
Institute
Department

Funding Source
Organization	Nissin Pharma Inc.
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	Miyawaki Orthopedic Clinic Industrial Review Board
Address	3-1-6 Ariaketyou,Eniwa-shi,Hokkaido, Japan
Tel	0123-33-4026
Email	d-kameda@mediffom.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 03 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	12
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 02 Month 05 Day
Date of IRB	2019 Year 02 Month 05 Day
Anticipated trial start date	2019 Year 03 Month 06 Day
Last follow-up date	2019 Year 03 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 05 Day
Last modified on	2019 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041037