UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the efficacy of dietary fiber-containing beverage on postprandial blood glucose elevation
Acronym	The effect of dietary fiber-containing beverage on postprandial blood glucose
Scientific Title	Evaluation of the efficacy of dietary fiber-containing beverage on postprandial blood glucose elevation
Scientific Title:Acronym	The effect of dietary fiber-containing beverage on postprandial blood glucose
Region	Japan

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

Objectives
Narrative objectives1	To verify the efficacy of dietary fiber-containing beverage on postprandial blood glucose elevation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose levels, the peak value of blood glucose levels, delta blood glucose levels, delta Cmax (the peak value of delta blood glucose levels), IAUC (areas calculated based on the change of delta blood glucose levels)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Drinking placebo beverage with eating 150 g of cooked rice
Interventions/Control_2	Drinking dietary fiber-containing beverage with eating 150 g of cooked rice
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Healthy adults (20 years or older) who do not get treatment or medication 2) Subjects who are normoglycemia or borderline diabetes in previous medical check-ups 3) Subjects whose fasting blood glucose levels are less than 126 mg/dL or blood glucose levels after oral glucose tolerance test (OGTT) are less than 200 mg/dL in the screening test 4) Subjects who do not fit the key exclusion criteria 5) Subjects who are judged healthy by investigators
Key exclusion criteria	1) Subjects who have food allergy to the test meals 2) Subjects who have remarkable hypersensitivity to alcohol 3) Subjects who will get pregnant or breast-feed during the study period 4) Subjects who join other human studies 5) Subjects who are judged unsuitable for this study by investigators
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Takuro Middle name Last name Inoue
Organization	KAGOME CO., LTD.
Division name	Innovation Division
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL	0287-36-2935
Email	Takuro_Inoue@kagome.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F, 5-31-19, Shiba, Minato-ku, Tokyo
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	KAGOME CO., LTD.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	HUMA R&D CORP
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committees of Nihonbashi Egawa Clinic
Address	2F Kotobuki Build. 1-1-3 Yaesu, Chuo-ku, Tokyo
Tel	03-5204-0311
Email	jim@medipharma.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	医療法人社団桜緑会 日本橋さくらクリニック(東京都)（Nihonbashi Sakura Clinic）

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	50
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	Main results already published
Date of protocol fixation	2020 Year 02 Month 06 Day
Date of IRB	2020 Year 02 Month 25 Day
Anticipated trial start date	2020 Year 02 Month 26 Day
Last follow-up date	2020 Year 03 Month 18 Day
Date of closure to data entry	2020 Year 03 Month 19 Day
Date trial data considered complete	2020 Year 04 Month 03 Day
Date analysis concluded	2020 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date	2020 Year 02 Month 25 Day
Last modified on	2020 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045109