Unique ID issued by UMIN | UMIN000047148 |
---|---|
Receipt number | R000053785 |
Scientific Title | Study of the superiority of Complete Nutrition Meals in diabetes mellitus patients. |
Date of disclosure of the study information | 2023/08/13 |
Last modified on | 2023/01/17 13:44:55 |
Study of the superiority of Complete Nutrition Meals in diabetes mellitus patients.
Study of the superiority of Complete Nutrition Meals in diabetes mellitus patients.
Study of the superiority of Complete Nutrition Meals in diabetes mellitus patients.
Study of the superiority of Complete Nutrition Meals in diabetes mellitus patients.
Japan |
Type 2 diabetes mellitus
Medicine in general |
Others
NO
Exploratory verification of the superiority of eating Complete Nutrition Meals in diabetes mellitus patients.
Efficacy
HbA1c
Evaluate before ingestion, 6 weeks and 12 weeks after ingestion.
Medication effect score
Fasting glucose level
Physical measurement (body weight, BMI, abdominal circumference)
Clinic blood pressure
Body-fat percentage
QOL examination
Fasting clinical examination
Evaluate before ingestion, 6 weeks and 12 weeks after ingestion.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Research food replaces one meal daily with Complete Nutrition Meals for 12 weeks.
50 | years-old | <= |
75 | years-old | > |
Male and Female
(1) Male and female who were diagnosed with type 2 diabetes mellitus more than one year ago and are 50 or more and under 75 years of age.
(2) Subjects with HbA1c of 7% or more and less than 9% at the time of pre-examination.
(3) Subjects with a BMI of 23 kg/m2 or more.
(4) Subjects who have been receiving the same diabetes mellitus treatment for 3 months or more before the pre-examination.
(5) Subjects who have agreed in writing to participate in the study and can be tested on the designated test date.
(1) Subjects who cannot continuously ingest research foods due to business trips etc. during the intake period.
(2) Subjects receiving treatment with insulin preparations (including treatment within the past 3 months).
(3) Patients with a history of severe hypoglycemia in the past.
(4) Subjects with a history of proliferative retinopathy or more, or diabetic nephropathy stage III or more.
(5) Subjects who self-reported a weight change of 5% or more within 3 months before the pre-examination.
(6) Subjects with a history of myocardial infarction or stroke within the past year.
(7) Subjects who are planning to change, add new or discontinue the treatment method for diabetes mellitus between the pre-examination and the intake start examination.
(8) Subjects with food allergies.
(9) Subjects with an average daily alcohol intake of more than 60 g.
(10) Subjects with a smoking habit of more than 21 cigarettes per day.
(11) Subjects who are judged by the principal investigator to be at risk of being hospitalized or having dietary restrictions etc. that may affect the continuation of the study or the intake of the research foods.
(12) Subjects with diseases that may turn into serious adverse events during the study period, such as cancer.
(13) Subjects who cannot properly store and ingest research foods due to reasons such as the inability to install a freezer to distribute and the lack of a microwave oven.
(14) Subjects who cannot record diary or answer questionnaires on the Web.
(15) Subjects with implantable medical devices such as cardiac pacemakers or life-sustaining medical devices such as biometric monitors.
(16) Subjects who are planning to become pregnant or breastfeed during the study period.
(17) Subjects who are participating in other clinical studies (including clinical trials) at the start of this study.
(18) Subjects who are judged as unsuitable for the study by the investigator for other reason.
30
1st name | Futoshi |
Middle name | |
Last name | Nakamura |
NISSIN FOODS HOLDINGS CO., LTD.
New Business Development Division
192-0001
2100 Tobukimachi, Hachioji-shi, Tokyo
042-696-7606
futoshi.nakamura@nissin.com
1st name | Shingo |
Middle name | |
Last name | Yamamichi |
EP Mediate Co., Ltd.
Foods Department, Trial Planning Section
162-0821
1-8 Tsukudocho, Shinjuku-ku, Tokyo Kagurazaka AK Building 7F
090-4821-1099
yamamichi.shingo578@eps.co.jp
EP Mediate Co., Ltd.
NISSIN FOOD PRODUCTS CO., LTD.
Profit organization
Medical Station Clinic Research Ethics Committee
3-12-8, Takaban, Meguroku, Tokyo
03-6452-2712
nakagawa.akiko297@eps.co.jp
NO
2023 | Year | 08 | Month | 13 | Day |
Unpublished
Completed
2022 | Year | 03 | Month | 10 | Day |
2022 | Year | 03 | Month | 10 | Day |
2022 | Year | 03 | Month | 16 | Day |
2022 | Year | 08 | Month | 13 | Day |
2022 | Year | 03 | Month | 11 | Day |
2023 | Year | 01 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053785