UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028824
Receipt number 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 10:50:23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Healthcare Systems Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.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