Unique ID issued by UMIN | UMIN000039911 |
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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 |
Exploratory trial about the effect of carotenoid rich carrot on intestinal environment and bioregulatory function.
Exploratory trial about the effect of carotenoid rich carrot on intestinal environment and bioregulatory function.
Exploratory trial about the effect of carotenoid rich carrot on intestinal environment and bioregulatory function.
Exploratory trial about the effect of carotenoid rich carrot on intestinal environment and bioregulatory function.
Japan |
N/A(healthy adults)
Adult |
Others
NO
To verify the effect of intestional environment and bioregulatory function(in particular the effect of oxidative stress) by carotenoid rich carrot intake.
Efficacy
gut microbiota(variety and ratio of bacteria in stool)
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Duration: 8 weeks
Test material: Food containing carrot concentrate
Dose: Two times a day
Administration: Take test material before breakfast and dinner
20 | years-old | <= |
65 | years-old | >= |
Male and Female
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).
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.
30
1st name | Yuji |
Middle name | |
Last name | Naito |
Kyoto Prefectural University of Medicine
Department of Gastroenterology and Hepatology
602-8566
Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto 602-8566,JAPAN.
075-251-5519
ynaito@koto.kpu-m.ac.jp
1st name | Tomohisa |
Middle name | |
Last name | Takagi |
Kyoto Prefectural University of Medicine
Department of Gastroenterology and Hepatology
602-8566
Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto 602-8566,JAPAN.
075-251-5508
takatomo@koto.kpu-m.ac.jp
Kyoto Prefectural University Of Medicine
R&D matching funds on the field for Knowledge Integration and innovation
Other
Kyoto Prefectural University of Medicine, Ethical Review Board
Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto 602-8566,JAPAN.
075-251-5337
rinri@koto.kpu-m.ac.jp
NO
2020 | Year | 08 | Month | 31 | Day |
Unpublished
33
Completed
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 06 | Month | 22 | Day |
2020 | Year | 08 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 23 | Day |
2022 | Year | 03 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045518
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