UMIN-CTR Clinical Trial

Basic information
Public title	A Trial to Evaluate HbA1c Reduction after 8 Weeks Ingestion of Inulin-Containing Food - Double Blind Randomized Placebo-Controlled Parallel Group Study -
Acronym	A Trial to Evaluate HbA1c Reduction after 8 Weeks Ingestion of Inulin-Containing Food
Scientific Title	A Trial to Evaluate HbA1c Reduction after 8 Weeks Ingestion of Inulin-Containing Food - Double Blind Randomized Placebo-Controlled Parallel Group Study -
Scientific Title:Acronym	A Trial to Evaluate HbA1c Reduction after 8 Weeks Ingestion of Inulin-Containing Food
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 to HbA1c reduction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in HbA1c from baseline value
Key secondary outcomes	HbA1c (measured), insulin (change and measured), insulin (change and measured), CPR(change and measured), HOMA-R, and intestinal flora (Bifidobacterium)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Daily ingestion of inulin-containing food for 8 weeks.
Interventions/Control_2	Daily ingestion of placebo food for 8 weeks.
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	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 with HbA1c values from 5.6 to <6.5 % at the time of screening. (3) Individuals who are available at every designated hospital visit. (4)Individuals who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria	(1)Individuals who have history of serious gastrointestinal disease, liver disease, kidney disease, cardiovascular disease, blood disease, endocrine system disease, or malignant neoplasm, or individuals who are suspected to have these diseases. (2) Individuals currently taking oral medication for internal diseases or receiving medical treatment. (3) Individuals planning to take medicine or to receive medical treatment during in this study. (4) Individuals planning to continuously take health food product or a supplement that indicates reduction of blood glucose and/or diabetes prevention during this study. (5) Individuals who have possibility of changing a lifestyle (i.e. night work, long travel or transfer) (6) Individuals with excessive alcohol drinking or heavy smoking (7) Individuals who may have allergies to Asteraceae plants in relation to the test food. (8) Individuals currently participating or planning to participate in any other clinical studies. (9) Individuals judged as inappropriate for the trial by the principal investigator.
Target sample size	20

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, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL	0118820111
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, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL	0118820111
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, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel	0118820111
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	2019 Year 10 Month 29 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	20
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 09 Month 30 Day
Date of IRB	2019 Year 10 Month 07 Day
Anticipated trial start date	2019 Year 10 Month 30 Day
Last follow-up date	2019 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 29 Day
Last modified on	2019 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043788