UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044210
Receipt number 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 19:00:25

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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 or person

Institute

Tezukayama University

Institute

Department

Personal name



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

Value
https://center6.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