UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory test on the influence of kestose intake on lifestyle-related diseases improvement effect
Title of the study (Brief title)	Exploratory test on the influence of kestose intake on lifestyle-related diseases improvement effect
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Explore the effect of kestose intake on lifestyle-related disease improvement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Insulin resistance (glucose, HbA1c, insulin, HOMA-IR, AUC, Cmax, C, myoinositol, creatinine) at the beginning of the test or after ingestion of 4, 8 and 12 weeks
Key secondary outcomes	Cholesterol (total cholesterol, LDL-cholesterol), blood neutral fat (TG), general blood biochemical test (HDL-cholesterol, AST, ALT, g-GT, urea nitrogen, creatinine , TNF-a, IL-1b, IL-6, IL-10, BDNF), intestinal environment (urine, albumin, total protein, ALP, LD, sodium, chlorine, potassium, calcium, inorganic phosphorus, magnesium, free fatty acid, (indoxyl sulfate, creatinine, short chain fatty acid, intestinal bacteria), stress (IgA), physical examination (body weight, blood pressure, pulse rate, BMI), questionnaire, at the beginning of the test or after ingestion of 4, 8 and 12 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingest total 10 g of kestose, 5 g each in the morning and the night.
Interventions/Control_2	Ingest total 10 g of maltose, 5 g each in the morning and the night.
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Healthy Japanese who is 20 years old or more and under 64 years old 3.Persons whose BMI is 23 or more at screening
Key exclusion criteria	1.Persons who have a chronic disease and is under medication, or has a serious disease history 2.Persons whose HOMA-IR at screening is 2.5 or more 3.Persons whose fasting blood glucose level at screening is 126 mg/dL or more 4.Persons whose LDL cholesterol at screening is 140 mg/dL or more 5.Persons whose blood neutral fat at screening is 150 mg/dL or more 6.Persons who are allergic to the test food 7.Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement 8.Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period 9.Persons who are judged inappropriate for the exam by the principal investigator
Target sample size	60

Research contact person
Name of lead principal investigator	Hirohito Ishikawa
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	0368092722
Email	ishikawa@hc-sys.jp

Public contact
Name of contact person	Hirohito Ishikawa
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	0368092722
Homepage URL
Email	ishikawa@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization	B Food Science Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2017 Year 08 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 22 Day
Anticipated trial start date	2017 Year 09 Month 02 Day
Last follow-up date	2018 Year 01 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 25 Day
Last modified on	2018 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032991