UMIN-CTR Clinical Trial

Basic information
Public title	Verification of the efficacy and effective dose of dietary fibers on postprandial blood glucose elevation
Acronym	The effect of dietary fibers on postprandial blood glucose
Scientific Title	Verification of the efficacy and effective dose of dietary fibers on postprandial blood glucose elevation
Scientific Title:Acronym	The effect of dietary fibers 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 and effective dose of dietary fibers 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, delta blood glucose levels, delta Cmax (The peak value of the 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	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Drinking 200 mL of water with eating 150 g of cooked rice
Interventions/Control_2	Drinking 200 mL of test beverage A (low dietary fiber)with eating 150 g of cooked rice
Interventions/Control_3	Drinking 200 mL of test beverage B(high dietary fiber X) with eating 150 g of cooked rice
Interventions/Control_4	Drinking 200 mL of test beverage C(high dietary fiber Y) with eating 150 g of cooked rice
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	Subjects who satisfy the following conditions 1) Who do not fit key exclusion criteria 2) Who provide written informed consents
Key exclusion criteria	1) Who has abnormal glucose tolerance in medical check-ups for the prior year 2) Who has food allergy to the test meals 3) Who has remarkable hypersensitivity to alcohol 4) Who will get pregnant or breast-feed during the study period 5) Who join other human studies 6) Who are judged unsuitable for this study by principal investigator
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Aizawa
Organization	KAGOME CO., LTD.
Division name	Innovation Division
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL	+81-287-36-2935
Email	Koichi_Aizawa@kagome.co.jp

Public contact
Name of contact person	1st name Kazutaka Middle name Last name Yoshida
Organization	KAGOME CO., LTD.
Division name	Innovation Division
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL	+81-287-36-2935
Homepage URL
Email	Kazutaka_Yoshida@kagome.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
Name of secondary funder(s)

IRB Contact (For public release)
Organization	KAGOME CO., LTD.
Address	3-21-1 Nihonbashihamacho, Chuoku, Tokyo, Japan
Tel	+81-3-5623-8501
Email	Takuji_Hayakawa@kagome.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	2018 Year 11 Month 15 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	14
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	2018 Year 10 Month 17 Day
Date of IRB	2018 Year 10 Month 17 Day
Anticipated trial start date	2018 Year 11 Month 15 Day
Last follow-up date	2019 Year 02 Month 28 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 11 Month 05 Day
Last modified on	2019 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039616