UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000040410
Receipt No. R000045726
Scientific Title Study on the effect of brown rice cracker with enhanced dietary fiber on blood sugar rise
Date of disclosure of the study information 2020/05/15
Last modified on 2020/11/16 (Ver. 4)

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Basic information
Public title Study on the effect of brown rice cracker with enhanced dietary fiber on blood sugar rise
Acronym Study on the effect of brown rice cracker with enhanced dietary fiber on blood sugar rise
Scientific Title Study on the effect of brown rice cracker with enhanced dietary fiber on blood sugar rise
Scientific Title:Acronym Study on the effect of brown rice cracker with enhanced dietary fiber on blood sugar rise
Region
Japan

Condition
Condition Adult
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is an exploratory study aimed at verifying whether the intake of brown rice crackers with enhanced dietary fiber can be expected to have a higher blood sugar suppression effect than the intake of ordinary white rice crackers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Since this study is an exploratory study of "whether brown rice crackers reinforced with dietary fiber suppress an increase in blood sugar levels", only the blood sugar level using a simple blood glucose meter is used as an evaluation item. Blood glucose is measured by fingertip puncture with a simple blood glucose meter before, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, and 120 minutes after ingestion.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 A group that consumes brown rice crackers with enhanced dietary fiber.
Ingest a single 100g test meal within 10 minutes.
Interventions/Control_2 A group that consumes regular white rice crackers.
Ingest a single 100g test meal within 10 minutes.
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
70 years-old >
Gender Male
Key inclusion criteria (1) Fasting blood glucose level is less than 126 mg / dL
(2) Those who have determined that the researcher can participate in the research safely
Key exclusion criteria (1) Those who are receiving treatment or medication for diabetes
(2) Those who have severe cerebrovascular disease, heart disease, renal disease, digestive disease
(3) Patients with a large history of gastrointestinal surgery, such as gastrectomy, gastrointestinal suture, or gastrointestinal resection
(4) Participants who are currently participating in other clinical research or have been participating within one month
(5) Others who are judged to be inappropriate for the research subject
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hirohiro
Middle name
Last name Sone
Organization Niigata University Faculty of Medicine
Division name Department of Hematology, Endocrinology and Metabolism
Zip code 9518510
Address 1-757, Asahimachidori, Chuouku, Niigata city, Niigata, Japan
TEL 0253689026
Email sone@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Suzuki
Organization Niigata University Faculty of Medicine
Division name Department of Hematology, Endocrinology and Metabolism
Zip code 9518510
Address 1-757, Asahimachidori, Chuouku, Niigata city, Niigata, Japan
TEL 0253689302
Homepage URL
Email hiroshi-suzuki@med.niigata-u.ac.jp

Sponsor
Institute Niigata University Faculty of Medicine
Department of Hematology, Endocrinology and Metabolism
Institute
Department

Funding Source
Organization Niigata University Faculty of Medicine
Department of Hematology, Endocrinology and Metabolism
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 Research Ethics Review Committee for Niigata University
Address 1-757, Asahimachidori, Chuouku, Niigata city, Niigata, Japan
Tel 0252236161
Email ethics@adm.niigata-u.ac.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 05 Month 15 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 9
Results 
A crossover study was conducted in which subjects ingested fiber-enriched white rice crackers and brown rice crackers. 60 and 120 minutes after ingesting fiber-enriched brown rice crackers, the rise in blood glucose was suppressed that compared to when you ingested white rice crackers.
Results date posted
2020 Year 11 Month 16 Day
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
2020 Year 04 Month 08 Day
Date of IRB
2020 Year 05 Month 14 Day
Anticipated trial start date
2020 Year 05 Month 15 Day
Last follow-up date
2020 Year 05 Month 31 Day
Date of closure to data entry
2020 Year 11 Month 16 Day
Date trial data considered complete
2020 Year 11 Month 16 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 05 Month 15 Day
Last modified on
2020 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045726