Unique ID issued by UMIN | UMIN000038152 |
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Receipt number | R000043462 |
Scientific Title | Effects of health programs on blood glucose and blood pressure |
Date of disclosure of the study information | 2019/10/01 |
Last modified on | 2020/02/28 15:51:28 |
Effects of health programs on blood glucose and blood pressure
Effects of health programs on blood glucose and blood pressure
Effects of health programs on blood glucose and blood pressure
Effects of health programs on blood glucose and blood pressure
Japan |
Adult males and females
Medicine in general | Adult |
Others
NO
Evaluate the effects of health programs that support test food intake on blood glucose and blood pressure
Efficacy
Blood glucose and HbA1c
Blood pressure
Body weight / Body fat / BMI
Activity
Glycoalbumin
Insulin and HOMA-R index
Blood lipids (triglyceride, total cholesterol, HDL, LDL cholesterol)
Uric acid level
Defecation frequency and days
Adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Prevention
Food |
Previous observation (2 weeks)-Intake of test foods (12 weeks)
20 | years-old | <= |
60 | years-old | >= |
Male and Female
(1) Males and females aged between 20 and 60
(2) Subjects who can agree to participate in this study
(3) Subjects who can go to hospital on designated day
(4) Subjects whose HbA1c value is 5.6 to 7.0%
(5) Subjects whose blood pressure is 120-145 / 80-95mmHg
(6) Appropriate admission to the study by the doctor
(1) Subjects routinely taking medicine
(2) Subjects who have under treatment or a history of serious disease. (Mental illness, sleep disorder, liver, kidney, heart, lung, blood, etc.)
(3) Subjects who have under treatment or a history of serious disease of the digestive tract.
(4) Subjects who donated blood (blood donation etc.) exceeding 200 mL within 1 month or 400 mL within 3 months
(5) Subjects who have experienced bad mood or poor physical condition due to blood sampling
(6) Subjects having possibilities for emerging allergy related to the current study
(7) Subjects who drink much alcohol
(8) Subjects who may drastically change their lifestyle during the study (such as long trips)
(9) Subjects who are pregnant, breastfeeding or have the possibility of becoming pregnant
(10) Subjects who have participated in other clinical study within the last 3 month or have plan to participate other clinical studies
(11) Subjects who works for a company where the person or family develops, manufactures or sells health / functional foods and cosmetics
(12) Subjects who are judged as ineligible by the clinical investigator
100
1st name | Satoki |
Middle name | |
Last name | Homma |
Saitama Medical Center
Health management center
3300074
4-9-3, Kitaurawa, Urawa-ku, Saitama-shi, Saitama
0569-24-5139
rintaro.kishi@welby.jp
1st name | Rintaro |
Middle name | |
Last name | Kishi |
Welby Inc.
Research Development Office
1030023
Toushou Bldg. 5F, 3-8-3, Nihonbashi Honchou, Chuo-ku, Tokyo
03-6206-2937
rintaro.kishi@welby.jp
Welby Inc.
Mizkan Holdings Co., Ltd.
Profit organization
The Ethics Committee of Ueno-Asagao Clinic
Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015
03-6240-1162
jimukyoku@tes-h.co.jp
NO
2019 | Year | 10 | Month | 01 | Day |
Unpublished
20
Completed
2019 | Year | 09 | Month | 02 | Day |
2019 | Year | 09 | Month | 11 | Day |
2019 | Year | 10 | Month | 01 | Day |
2020 | Year | 01 | Month | 31 | Day |
2019 | Year | 09 | Month | 30 | Day |
2020 | Year | 02 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043462
Research Plan | |
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Research case data specifications | |
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