UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028707
Receipt number R000032864
Scientific Title The study to investigate the living body control function of "Koiaona", which is a cultivar of the kale highly including carotenoids and glucosinolates : a randomized, double-blinded, placebo-controlled trial.
Date of disclosure of the study information 2018/02/01
Last modified on 2019/08/20 09:31:43

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Basic information

Public title

The study to investigate the living body control function of "Koiaona", which is a cultivar of the kale highly including carotenoids and glucosinolates : a randomized, double-blinded, placebo-controlled trial.

Acronym

The study of living body control function by "Koiaona".

Scientific Title

The study to investigate the living body control function of "Koiaona", which is a cultivar of the kale highly including carotenoids and glucosinolates : a randomized, double-blinded, placebo-controlled trial.

Scientific Title:Acronym

The study of living body control function by "Koiaona".

Region

Japan


Condition

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To verify the living body control function by the carotenoids and glucosinolate intake, in particular the effectiveness to lipid metabolism.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Biomarkers of blood lipids such as LDL-C, HDL-C and TG will be measured as primary endpoint. The changes will be compared within each group and between the treatment groups.

Key secondary outcomes

As secondary endpoints, following items will be evaluated; blood examination involving oxidative stress and special items such as s-LOX1, carotenoid, inflammation, mitochondrial function index, urinalysis, physiological parameters, variety and ratio of bacteria in stool and meal nourishment.


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

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test material:"Koiaona " powder
Dose: Take one package, two times a day
Administration: Take one package before breakfast and dinner

Interventions/Control_2

Duration: 12 weeks
Test material:Placebo
Dose: Take one package, two times a day
Administration: Take one package before breakfast and dinner

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 and Female

Key inclusion criteria

1)20yrs<=age<=65yrs
2)Male and Female
3)Outpatients
4)120mg/dl<=LDL-Cholesterol<=159mg/dl
5)Those who are able to take the test foods during 3 months.
6)Those who don't change living habits such as exercise, diet, sleeping etc during the study period
7)consent document

Key exclusion criteria

1) Smokers
2)Those who are taking drugs for disease treatment
3) serious heart disease [heart failure, myocardial infarction, myocarditis, etc.] liver disease [liver failure symptoms (fulminant hepatitis ),patients with cirrhosis of the liver, liver tumor], renal disease [nephrotic syndrome, renal failure (acute and chronic), uremia, merged, etc. hydronephrosis]
4) Those who have participated in other clinical trials within before consent get one month,
and those who are currently participating in other clinical trials.
5) At the physician's judgment, who it is determined that there is a possibility that either increased risk to the subject, or sufficient data not obtained
6) Those who take antibiotics within before consent get one month
7) Those who currently take health foods

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Naito

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

602-8566

Address

Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto 602-8566,JAPAN.

TEL

075-251-5519

Email

ynaito@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Tomohisa
Middle name
Last name Takagi

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

602-8566

Address

Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto 602-8566,JAPAN.

TEL

075-251-5508

Homepage URL


Email

takatomo@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University Of Medicine

Institute

Department

Personal name



Funding Source

Organization

R&D matching funds on the field for Knowledge Integration and innovation

Organization

Division

Category of Funding Organization

Other

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

2018 Year 02 Month 01 Day


Related information

URL releasing protocol

Unpublished

Publication of results

Unpublished


Result

URL related to results and publications

Unpublished

Number of participants that the trial has enrolled

43

Results

Unpublished

Results date posted

2019 Year 08 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Unpublished

Participant flow

Unpublished

Adverse events

Unpublished

Outcome measures

Unpublished

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 10 Month 13 Day

Date of IRB

2017 Year 10 Month 26 Day

Anticipated trial start date

2018 Year 03 Month 15 Day

Last follow-up date

2018 Year 06 Month 15 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 17 Day

Last modified on

2019 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032864


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name