Unique ID issued by UMIN | UMIN000039382 |
---|---|
Receipt number | R000044898 |
Scientific Title | Effects of functional dietary ingredients on post-meal bodily sensation |
Date of disclosure of the study information | 2020/02/04 |
Last modified on | 2021/08/13 09:33:50 |
Effects of functional dietary ingredients on post-meal bodily sensation
Effects of functional dietary ingredients on post-meal bodily sensation
Effects of functional dietary ingredients on post-meal bodily sensation
Effects of functional dietary ingredients on post-meal bodily sensation
Japan |
Healthy subjects
Adult |
Others
NO
The purpose of this study is to examine the effect on the bodily sensation after a single intake of meal containing functional dietary ingredient for healthy Japanese men and women aged 20 to 60 years using a questionnaire.
Safety
Subjective evaluation of the bodily sensation using questionnaire (frequency and intensity of bodily sensation, and their cumulative value), physical condition changes after meals, vital signs,BMI,adverse events
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
Take test food A once on the day of the test.
Take test food B once on the day of the test.
Take test food placebo once on the day of the test.
20 | years-old | <= |
60 | years-old | > |
Male and Female
1.Japanese male and female aged 20 to 60 years of aged at the time of the informed consent.
2.Subject who meets the human rights protection viewpoint and selection criteria, does not violate the exclusion criteria, and can comply with the management items during the test period.
3.BMI within 20.2kg/m2 to 27.2 kg/m2 for males and 18.5kg/m2 to 25.2kg/m2 for females.
4.Non-smoker
5. Subject who receives a sufficient explanation of the purpose and contents of the research, has the consent ability, and has a good understanding, voluntarily volunteer to participate in the research and has agreed in writing to participate in the research.
1.Subject who has a weight fluctuation of more than +-10kg within one year.
2.Subject who has experienced chest pain or abnormal pulse at rest.
3.Subject who frequently experience shortness of breath, dizziness, and loss of consciousness.
4.A family member who has died suddenly for unknown reasons.
5.Subject who has been diagnosed as having problems with the legs.
6.Subject who is treating rheumatism.
7.Subject who is taking medication or under medical treatment because of some serious illness.
8.Subject with a history of knee surgery or disease, or who regularly use of cane.
9.Subject with a history of allergies to drug, food, test food ingredients (milk protein, etc.)
10.Subject with a history of drug dependence or alcohol dependence.
11.Subject who has or had suspected of disorder with mental(such as depression) or sleep (such as insomnia and sleep apnea syndrome).
12.Subject who has irregular work rhythms such as working at night.
13.Subject who works in factories, construction, construction sites, etc. and engage in manual labor that overuses their bodies.
14.Subject who has extremely irregular lifestyle such as eating and sleeping.
15.Subject who has an unbalanced diet.
50
1st name | Naohisa |
Middle name | |
Last name | Nosaka |
The Nisshin OilliO Group, Ltd
Central Research Laboratory
235-8558
1 Shinmori-cho, Isogo-ku, Yokohama-shi, Kanagawa
045-757-5461
n-nosaka@nisshin-oillio.com
1st name | Daisuke |
Middle name | |
Last name | Ochitani |
HUMA R&D CORP
Clinical Development Division
108-0014
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
03-3431-1260
ochitani@huma-rd.co.jp
HUMA R&D CORP
The Nisshin OilliO Group, Ltd.
Profit organization
Ethics Committees of Nihonbashi Egawa Clinic
2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
03-5204-0311
jim@medipharma.co.jp
NO
2020 | Year | 02 | Month | 04 | Day |
Unpublished
Completed
2019 | Year | 12 | Month | 13 | Day |
2019 | Year | 12 | Month | 13 | Day |
2020 | Year | 02 | Month | 07 | Day |
2020 | Year | 04 | Month | 30 | Day |
2020 | Year | 04 | Month | 30 | Day |
2020 | Year | 05 | Month | 14 | Day |
(Exclusion criteria continued)
16.Subject who has onset or history of serious disease (diseases on brain, liver (hepatitis), kidney, heart, immune system, thyroid, adrenal, and other metabolic organs, dysorder on glucose or lipid metabolism (diabetes or dyslipidemia), and cancer (malignant tumor)).
17.Subject who is taking health foods, supplements, or drugs that may affect fatigue reduction.
18.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
19.Subject who drawed 200mL or more (within the past 1 months from the day of the consent acquisition) or 400mL or more of blood (within the past 3 months from the day of the consent acquisition).
20.Subject who is planning to donate blood or receive vaccinations, or who wish to donate or vaccinate during the test period.
21.Subject who is pregnancy, lactation, or wishs to become pregnant during the study period.
22.Subject who can't keep the daily records.
23.Subject who is considered as an inappropriate by the medical doctor.
2020 | Year | 02 | Month | 04 | Day |
2021 | Year | 08 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044898
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