Unique ID issued by UMIN | UMIN000043989 |
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Receipt number | R000050236 |
Scientific Title | Evaluation of the effects of consumption of test foods containing plant-derived bioactive substances on the biomarker in blood: a preliminary study |
Date of disclosure of the study information | 2021/04/21 |
Last modified on | 2021/10/20 12:57:08 |
Evaluation of the effects of consumption of test foods containing plant-derived bioactive substances on the biomarker in blood: a preliminary study
Evaluation of the effects of consumption of test foods containing plant-derived bioactive substances on the biomarker in blood: a preliminary study
Evaluation of the effects of consumption of test foods containing plant-derived bioactive substances on the biomarker in blood: a preliminary study
Evaluation of the effects of consumption of test foods containing plant-derived bioactive substances on the biomarker in blood: a preliminary study
Japan |
Healthy subjects
Not applicable | Adult |
Others
NO
To evaluate the effects of ingestion of plant-derived bioactive substances on blood biomarker concentrations. In addition, the effect of ingestion of plant-derived bioactive substances on appetite will be evaluated as the secondary endpoints.
Efficacy
Blood biomarker concentrations
Appetite score, nutrient intake
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Intake the test food for 4 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1) males and females over 20 years old
1) Those who have factors other than dietary habits that greatly affect blood biomarker concentration (those who have an infectious disease within 1 month of the start of the study, those who take antibiotics within 1 month of the start of the study, those who have chronic digestive disorders, etc.)
2) Those who have factors other than blood biomarker concentration that greatly affect appetite (Those who eat less than two meals a day on some days,those who are undergoing hormone therapy, etc.)
3) Those who may have adverse events when collecting blood (those who are sensitive to alcohol to the extent that alcohol disinfection is difficult, those who have skin diseases on their fingers, etc.)
4) Those who may develop allergies due to ingestion of the test food
5) Those who regularly use health foods that contain a high amount of ingredients similar to those involved in the test food.
6) Those who regularly use health foods high in fructooligosaccharide / inulin, galactooligosaccharide, indigestible dextrin, and insoluble dietary fiber
7) Those who routinely ingest plant foods and their processed products that contain high amounts of ingredients similar to those involved in test foods.
8) Those who participated in other human studies within 1 month of the start of this study
9) Those who are lactating, pregnant, or who wish to become pregnant during the study period.
10) Those who are judged to be inappropriate by the investigator or the principal investigator
25
1st name | Yusuke |
Middle name | |
Last name | Ushida |
KAGOME CO., LTD.
Nature & Wellness Research Department, Innovation Division
329-2762
17 Nishitomiyama, Nasushiobara, Tochigi, Japan
0287-36-2935
Yusuke_Ushida@kagome.co.jp
1st name | Nobuo |
Middle name | |
Last name | Fuke |
KAGOME CO., LTD.
Nature & Wellness Research Department, Innovation Division
329-2762
17 Nishitomiyama, Nasushiobara, Tochigi, Japan
0287-36-2935
Nobuo_Fuke@kagome.co.jp
KAGOME CO., LTD.
KAGOME CO., LTD.
Profit organization
the ethics committees of KAGOME CO., LTD.
3-21-1, F tower, Hamacho, Nihonbashi, Tyuo-ku, Tokyo, Japan
03-5623-8501
Takuji_Hayakawa@kagome.co.jp
YES
2021-R02
the ethics committees of KAGOME CO., LTD.
カゴメ株式会社(栃木県)
2021 | Year | 04 | Month | 21 | Day |
Unpublished
25
Completed
2021 | Year | 04 | Month | 06 | Day |
2021 | Year | 04 | Month | 20 | Day |
2021 | Year | 05 | Month | 12 | Day |
2021 | Year | 07 | Month | 02 | Day |
2021 | Year | 04 | Month | 20 | Day |
2021 | Year | 10 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050236
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