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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039911
Receipt No. 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 2020/06/24

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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
Institute Kyoto Prefectural University Of Medicine
Institute
Department

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
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 Preinitiation
Date of protocol fixation
2020 Year 03 Month 31 Day
Date of IRB
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
2020 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.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


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