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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039398
Receipt No. R000044919
Scientific Title A Trial to Evaluate Inulin-Containing Food on Suppression of Postprandial Blood Glucose - Double Blind Randomized Placebo-Controlled Crossover Study -
Date of disclosure of the study information 2020/02/05
Last modified on 2020/02/05

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Basic information
Public title A Trial to Evaluate Inulin-Containing Food on Suppression of Postprandial Blood Glucose
- Double Blind Randomized Placebo-Controlled Crossover Study -
Acronym A Trial to Evaluate Inulin-Containing Food on Suppression of Postprandial Blood Glucose
Scientific Title A Trial to Evaluate Inulin-Containing Food on Suppression of Postprandial Blood Glucose
- Double Blind Randomized Placebo-Controlled Crossover Study -
Scientific Title:Acronym A Trial to Evaluate Inulin-Containing Food on Suppression of Postprandial Blood Glucose
Region
Japan

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

Objectives
Narrative objectives1 Objective is to evaluate the efficacy of ingestion of test food on Suppression of Postprandial Blood Glucose
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The area under the curve (AUC) of blood glucose (measured and variation from baseline)
Key secondary outcomes Blood glucose (measured), blood glucose Cmax (measured and variation from baseline), AUC of insulin (measured and variation from baseline), insulin (measured and variation from baseline), insulin Cmax (measured and variation from baseline)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingest the following three test foods in random order.

Test food "A": inulin-containing food "A"
Carbohydrate load: retort cooked rice(300g)

Intervals of each intervention are 5 days or more.
Interventions/Control_2 Test food "B": inulin-containing food "B"
Carbohydrate load: retort cooked rice(300g)


Interventions/Control_3 Placebo food: starch
Carbohydrate load: retort cooked rice(300g)

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
65 years-old >
Gender Male
Key inclusion criteria (1) Adult males from 20 to 64 years old at the time of giving consent.
(2) Individuals whose fasting blood glucose values are from 110 to <126 mg/dL at the time of screening, or individuals whose postprandial blood glucose values at 120 min are from 140 to <200 mg/dL in 75 g OGTT at the screening.
(3) Individuals who can make self-judgment to participate the study with their own will and can put signature and date to informed consent form by themselves prior to the study.

Key exclusion criteria (1) Individuals who have serious medical history or have undergone resection surgery of digestive tract.
(2) Individuals who have HbA1c (NGSP) values of 6.5 % or more.
(3) Individuals continuously taking medication, FOSHU or health food product that may influence the results of this study.
(4) Individuals who have allergies to Asteraceae plants and/or ingredients of the test foods or carbohydrate load.
(5) Individuals with excessive alcohol drinking or heavy smoking.
(6) Individuals judged as inappropriate for the study by the principal investigator.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Kazuhiko
Middle name
Last name Takano
Organization Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name Clinical Pharmacology Center
Zip code 004-0839
Address 61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL 011-882-0111
Email takano@ughp-cpc.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Matsuda
Organization Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name Clinical Pharmacology Center
Zip code 004-0839
Address 61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL 011-882-0111
Homepage URL
Email matsuda@ughp-cpc.jp

Sponsor
Institute Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

Funding Source
Organization NIHON TOUNYOU SYOKKEN CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Medical Corporation Hokubukai Utsukushigaoka Hospital institutional review board
Address 61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel 011-881-0111
Email matsuda@ughp-cpc.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 医療法人北武会 美しが丘病院(北海道)

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 05 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 15
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 No longer recruiting
Date of protocol fixation
2019 Year 12 Month 19 Day
Date of IRB
2019 Year 12 Month 26 Day
Anticipated trial start date
2020 Year 02 Month 06 Day
Last follow-up date
2020 Year 02 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 05 Day
Last modified on
2020 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044919

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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