UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009799
Receipt number R000011477
Scientific Title Study on lifestyle-related disease improvement effect by the kombu intake
Date of disclosure of the study information 2013/01/17
Last modified on 2016/01/18 08:50:16

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Basic information

Public title

Study on lifestyle-related disease improvement effect by the kombu intake

Acronym

Study on lifestyle-related disease improvement effect by the kombu

Scientific Title

Study on lifestyle-related disease improvement effect by the kombu intake

Scientific Title:Acronym

Study on lifestyle-related disease improvement effect by the kombu

Region

Japan


Condition

Condition

Hypertension, hyperlipemia, gout, glycohemia, diabetes, abnormal glucose tolerance, a fatty liver, obstipation, healthy

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Cardiology
Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this research, a healthy volunteer, hypertension patient, a hyperlipemic subject, a gout patient, a glycohemia patient, a diabetic, an abnormal-glucose-tolerance patient, a fatty liver patient, or an obstipation patient take in the kombu, and ingestion of the kombu verifies how it has contributed to our health by considering the influence on measurement of blood sugar, blood lipid, etc., the stomach and intestines, and bowels.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Validity of the kombu intake to hypertension, hyperlipemia, gout, glycohemia, diabetes, abnormal glucose tolerance, a fatty liver, and obstipation-Evaluation of blood components, urine components and various pathological condition

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

kombu intake for 4 weeks (6 g/1 day)>> Non intake for 4 weeks
or
Non intake for 4 weeks >> kombu intake for 4 weeks (6 g/1 day)

Interventions/Control_2


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


 Not applicable

Gender

Male and Female

Key inclusion criteria

1) Person who does not present allergy to the kombu
2) Person aged 20 and over
3) Person by whom written consent was got from the person himself/herself
4) Person who does not have thyroid disease

Key exclusion criteria

The case that is judged that doctors are unsuitable

Target sample size

540


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaru Yoshida

Organization

Kobe University Graduate School of Medicine

Division name

Division of Gastroenterology

Zip code


Address

7-5-1 Kusunoki-cho, Chu-o-ku, Kobe, Hyogo 650-0017, Japan.

TEL

078-382-6305

Email

myoshida@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masaru Yoshida

Organization

Kobe University Graduate School of Medicine

Division name

Division of Gastroenterology

Zip code


Address

7-5-1 Kusunoki-cho, Chu-o-ku, Kobe, Hyogo 650-0017, Japan.

TEL

078-382-6305

Homepage URL


Email

myoshida@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Agriculture, Forestry, and Fisheries

Organization

Division

Category of Funding 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

2013 Year 01 Month 17 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

2012 Year 12 Month 28 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 31 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 17 Day

Last modified on

2016 Year 01 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011477


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name