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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028824
Receipt No. R000032991
Scientific Title Exploratory test on the influence of kestose intake on lifestyle-related diseases improvement effect
Date of disclosure of the study information 2017/08/25
Last modified on 2018/01/15

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Basic information
Public title Exploratory test on the influence of kestose intake on lifestyle-related diseases improvement effect
Acronym Exploratory test on the influence of kestose intake on lifestyle-related diseases improvement effect
Scientific Title Exploratory test on the influence of kestose intake on lifestyle-related diseases improvement effect
Scientific Title:Acronym 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
1st name
Middle name
Last name Hirohito Ishikawa
Organization Healthcare Systems Co., Ltd.
Division name Research and Development
Zip code
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
1st name
Middle name
Last name Hirohito Ishikawa
Organization Healthcare Systems Co., Ltd.
Division name Research and Development
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2017 Year 07 Month 22 Day
Date of IRB
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

Other
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

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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