Unique ID issued by UMIN | UMIN000041985 |
---|---|
Receipt number | R000047883 |
Scientific Title | Effect of "healthy diet" intake on health awareness and physical |
Date of disclosure of the study information | 2020/10/05 |
Last modified on | 2021/09/01 11:24:27 |
Effect of "healthy diet" intake on health awareness and physical
Effect of "healthy diet" intake on health awareness and physical
Effect of "healthy diet" intake on health awareness and physical
Effect of "healthy diet" intake on health awareness and physical
Japan |
Healthy subjects
Adult |
Others
NO
The objective this study examines changes in health consciousness and physical condition by eating a "healthy diet" that is a balanced combination of multiple nutritional components that are considered to be good for healthy at breakfast and lunch, compared with before intake .
Safety,Efficacy
Defecation survey,Vital signs,Body composition,Bone density measurement,Visceral fat measurement,Ketone concentration in exhaled breath,SF-8 Japanese version,WLQ-J,OSA sleep inventory MA version,POMS2 shortened version,Dietary habits awareness survey, Blood biochemistry, Hematology,8-OHdG,Saliva s-IgA secretion concentration,Salivary s-IgA secretion rate, Intestinal flora test.
(Safety evaluation)
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
4-weeks intake of the test food
Not applicable |
Not applicable |
Male and Female
1)Employees, contingent workers-temporary, temporary employees working in cooperative company
2)Subject who can be inspected on the specified inspection date
3)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
1)Subject who cannot continue to take the test food due to business trips during the intake period (subject who is known in advance that the eating rate will be less than 80%)
2)Subject who is taking medication or under medical treatment.
3)Subject who is under exercise therapy or dietetic therapy.
4)Subject who has an allergy for test food.
5)Subject who has or had a history of either medicine or alcohol dependence syndrome.
6)Subject who has or had a history of mental illness (depression) or sleep disturbance.
7)Subject who has irregular work rhythms such as working at night and shift work.
8)Subject who has extremely irregular lifestyle such as eating and sleeping.
9)Subject who has an unbalanced diet.
10)Subject who has or had a history of severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases (including subject who uses implantable medical electrical equipment such as pacemakers, subject who uses implantable metal medical equipment, and subject who is undergoing artificial dialysis)
11)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.
12)Subject who has blood drawn or blood component more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition.
13))Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
14)Subject who can't keep the daily records.
15)Subject who is judged as an inappropriate candidate according to the screening data.
16)Subject who is considered as an inappropriate candidate by the doctor in charge.
110
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
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
non-disclosure
Profit organization
AMC Nishi-Umeda Clinic Ethical Review Committee
West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
06-4797-5660
jimukyoku@amc-clinc.jp
NO
2020 | Year | 10 | Month | 05 | Day |
Unpublished
110
Completed
2020 | Year | 09 | Month | 17 | Day |
2020 | Year | 09 | Month | 24 | Day |
2020 | Year | 10 | Month | 06 | Day |
2020 | Year | 12 | Month | 04 | Day |
2021 | Year | 01 | Month | 27 | Day |
2021 | Year | 01 | Month | 28 | Day |
2021 | Year | 02 | Month | 19 | Day |
2020 | Year | 10 | Month | 02 | Day |
2021 | Year | 09 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047883