UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039911
Receipt number R000045518
Scientific Title Exploratory trial about the effect of carotenoid rich carrot on intestinal environment and bioregulatory function.
Date of disclosure of the study information 2020/08/31
Last modified on 2022/03/25 10:02:22

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Basic information

Public title

Exploratory trial about the effect of carotenoid rich carrot on intestinal environment and bioregulatory function.

Acronym

Exploratory trial about the effect of carotenoid rich carrot on intestinal environment and bioregulatory function.

Scientific Title

Exploratory trial about the effect of carotenoid rich carrot on intestinal environment and bioregulatory function.

Scientific Title:Acronym

Exploratory trial about the effect of carotenoid rich carrot on intestinal environment and bioregulatory function.

Region

Japan


Condition

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effect of intestional environment and bioregulatory function(in particular the effect of oxidative stress) by carotenoid rich carrot intake.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

gut microbiota(variety and ratio of bacteria in stool)

Key secondary outcomes

Defecation status (fecal properties, number of defecations),
Bile acids and short-chain fatty acids in feces,
Blood carotenoid concentration,
Oxidative stress markers,
Oxidation-modified transthyretin,
Skin condition and fatigue level


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

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: 8 weeks
Test material: Food containing carrot concentrate
Dose: Two times a day
Administration: Take test material before breakfast and dinner

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Those who agree in writing to participate in this study.
2) Women and men aged 20 to 65 years.
3) Those who can observe the following lifestyle during the test period from one week before the start of the trial.
> Do not drink green tea more than usual before starting the trial.
> Do not eat foods with high polyphenol content such as chocolate.
> Do not take antibiotics.
> Do not use mouthwash.
> Abstain from taking probiotics (mainly yogurt).
> Do not eat natto more than usual before starting the trial.
> No smoking.
> Do not take prebiotics (dietary fiber and oligosaccharide supplements).

Key exclusion criteria

1) Those who are under treatment of diseases (Digestive disorders) which may influence the outcome of the study.
2) Whose diet is extremely irregular
3) Those who are routinely drinking a large amount of alcohol.
4) Smokers
5) Those who are habitually exercising such as marathon.
6) Currently, exercise therapy and diet therapy are performed/ planning to under the supervision of a physician.
7) 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], cranial nerve disease, psychiatric disease, malignant tumor disease, etc. and have a problem with general condition.
8) Those who have participated in other clinical trials within before consent get one month,and those who are currently participating in other clinical trials.
9) 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.

Target sample size

30


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

Kyoto Prefectural University of Medicine, Ethical Review Board

Address

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

Tel

075-251-5337

Email

rinri@koto.kpu-m.ac.jp


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

2020 Year 08 Month 31 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

33

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

2020 Year 03 Month 31 Day

Date of IRB

2020 Year 06 Month 22 Day

Anticipated trial start date

2020 Year 08 Month 31 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 03 Month 23 Day

Last modified on

2022 Year 03 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045518


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name