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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044210
Receipt No. R000050166
Scientific Title Blood sugar change of sweets using resistant starch
Date of disclosure of the study information 2021/05/14
Last modified on 2021/05/14

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Basic information
Public title Blood sugar change of sweets using resistant starch
Acronym Blood sugar change of sweets using resistant starch
Scientific Title Blood sugar change of sweets using resistant starch
Scientific Title:Acronym Blood sugar change of sweets using resistant starch
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will examine whether resistant starch is effective in suppressing the rise in blood sugar.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Since this study is an exploratory study of "Blood sugar change of sweets using resistant starch", only the blood glucose level by a simple blood glucose meter is used as an evaluation item. Before ingestion, 30 minutes after ingestion, 60 minutes after ingestion, 90 minutes after ingestion, and 120 minutes after ingestion, blood glucose is measured by fingertip puncture with a simple glucose meter.
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 Ingest food stored at room temperature.
Interventions/Control_2 Ingest food that has been returned to room temperature after refrigerated storage.
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
25 years-old >
Gender Male and Female
Key inclusion criteria Those who do not meet the exclusion criteria and have obtained consent
Key exclusion criteria (1) People with diabetes, serious heart disease, liver disease, kidney disease, blood disease, etc.
(2)Those with a fasting blood glucose level of 126 mg / dl or higher
(3)Body mass index (BMI) less than 18.5 kg / m2 or more than 25.0 kg / m2
(4) Persons with applicable food allergies (wheat, corn, rice, etc.)
(5)Persons with alcohol hypersensitivity
(6)Those who are taking anticoagulants
Target sample size 8

Research contact person
Name of lead principal investigator
1st name Sakiko
Middle name
Last name Abe
Organization Tezukayama University
Division name Faculty of Contemporary Life Studies, Department of Food and Nutrition
Zip code 631-8585
Address Gakuenminami 3-1-3, nara-shi, nara-ken
TEL 0742414742
Email sa-abe@tezukayama-u.ac.jp

Public contact
Name of contact person
1st name Sakiko
Middle name
Last name Abe
Organization Tezukayama University
Division name Faculty of Contemporary Life Studies, Department of Food and Nutrition
Zip code 631-8585
Address Gakuenminami 3-1-3, nara-shi, nara-ken
TEL 0742414742
Homepage URL
Email sa-abe@tezukayama-u.ac.jp

Sponsor
Institute Tezukayama University
Institute
Department

Funding Source
Organization Tezukayama University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tezukayama University
Address Gakuenminami 3-1-3, nara-shi, nara-ken
Tel 0742414742
Email sa-abe@tezukayama-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 Approval No. 02-21
Org. issuing International ID_1 Tezukayama University Human Research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 14 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
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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 05 Day
Date of IRB
2021 Year 03 Month 31 Day
Anticipated trial start date
2021 Year 05 Month 15 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 14 Day
Last modified on
2021 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050166

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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