Unique ID issued by UMIN | UMIN000026170 |
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Receipt number | R000030072 |
Scientific Title | The attenuating effect of substance X on postprandial serum triglyceride level in healthy human subjects. |
Date of disclosure of the study information | 2017/02/22 |
Last modified on | 2020/01/31 16:13:26 |
The attenuating effect of substance X on postprandial serum triglyceride level in healthy human subjects.
The attenuating effect of substance X on postprandial serum triglyceride level.
The attenuating effect of substance X on postprandial serum triglyceride level in healthy human subjects.
The attenuating effect of substance X on postprandial serum triglyceride level.
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the attenuationg effect of substance X on postprandial serum triglyceride elevation.
Efficacy
Serum triglyceride (0-6 hrs)
Serum RLP-cholesterol (0-6 hrs)
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
2
Treatment
Food |
Placebo meal : control meal (a single time intake) -> 1-week washout -> Test meal : control meal containing substance X (a single time intake)
Test meal : control meal containing substance X (a single time intake) -> 1-week washout -> Placebo meal : control meal (a single time intake)
20 | years-old | <= |
70 | years-old | > |
Male and Female
1)Healthy Japanese Subjects
2)Subjects whose fasting serum triglyceride levels are from 30 mg/dL less than 150 mg/dL.
1)Subjects with medical history of severe disorders.
2)Subjects with surgical history of digestive system (except appendectomy).
3)Subjects with continuous medical treatment for chronic disease.
4)Subjects who self-judge that diarrhea is likely to occur when they eat high fat diets.
5)Subjects regularly using medicine, supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) that may affect the results of the study.
6)Subjects consciously ingesting high-fiber foods.
7)Subjects who drink alcohol a lot regularly.
8)Pregnant or have possibility to become pregnant during the study or lactating women.
9)Subjects who have donated over 200 mL of blood and/or blood component within the past month, or subjects who have donated over 400 mL of blood and/or blood component within the past three months. Furthermore, subjects who will be donation over 1200 mL of blood and/or blood component within the past year, when adding the planned blood smpling volume in this study.
10)Subjects who judged as unsuitable for this study by the principal investigator for any reasons.
40
1st name | Yuki |
Middle name | |
Last name | Ishida |
Hayashibara CO., LTD.
R & D Division, Development Unit
7028006
675-1, Fujisaki, Naka-ku, Okayama
086-276-3141
yuki.ishida@hb.nagase.co.jp
1st name | Yuki |
Middle name | |
Last name | Ishida |
Hayashibara CO., LTD.
R & D Division, Development Unit
7028006
675-1, Fujisaki, Naka-ku, Okayama
086-276-3141
yuki.ishida@hb.nagase.co.jp
Medical Corporation Hokubu-kai, Utsukushigaoka Hospital
None
Self funding
Clinical Support Corporation
The Medical Corporation Hokubu-kai Utsukushigaoka Hospital
61-1, Shinei, Kiyota-ku, Sapporo
011-882-0111
wakimoto@ughp-cpc.jp
NO
医療法人北武会 美しが丘病 / Medical Corporation Hokubu-kai Utsukushigaoka Hospital (Hokkaido)
2017 | Year | 02 | Month | 22 | Day |
Unpublished
40
Completed
2017 | Year | 01 | Month | 19 | Day |
2017 | Year | 01 | Month | 19 | Day |
2017 | Year | 02 | Month | 23 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 06 | Month | 05 | Day |
2017 | Year | 02 | Month | 16 | Day |
2020 | Year | 01 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030072
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