UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049668 |
|---|---|
| Receipt number | R000056570 |
| Scientific Title | Study of the superiority of Complete Nutrition Meals in diabetes mellitus patients. |
| Date of disclosure of the study information | 2022/12/07 |
| Last modified on | 2024/06/11 15:50:51 |
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Basic information
Public title
Study of the superiority of Complete Nutrition Meals in diabetes mellitus patients.
Acronym
Study of the superiority of Complete Nutrition Meals in diabetes mellitus patients.
Scientific Title
Study of the superiority of Complete Nutrition Meals in diabetes mellitus patients.
Scientific Title:Acronym
Study of the superiority of Complete Nutrition Meals in diabetes mellitus patients.
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the superiority of eating Complete Nutrition Meals in diabetes mellitus patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Medication effect score
Evaluate before ingestion, 6 weeks, 12 weeks, 18 weeks and 24 weeks after ingestion.
Key secondary outcomes
HbA1c
Physical measurement (body weight, BMI, abdominal circumference)
Clinic blood pressure
Body-fat percentage
QOL examination
Physical activity
Meal record (BDHQ)
Fasting clinical examination
Evaluate before ingestion, 6 weeks, 12 weeks, 18 weeks and 24 weeks after ingestion.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Research food replaces one meal daily with Complete Nutrition Meals for 24 weeks.
Interventions/Control_2
None
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(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 who have been receiving the same diabetes mellitus treatment for 3 months or more before the pre-examination.
(3) Subjects with HbA1c of 7% or more and less than 9% for 3 months before the pre-examination.
(4) Subjects with HbA1c of 7% or more and less than 9% more than a months before the pre-examination.
(5) Subjects with HbA1c of 7% or more and less than 9% at the time of pre-examination.
(6) Subjects with a BMI of 23 kg/m 2 or more.
(7) Subjects who have agreed in writing to participate in the study and can be tested on the designated test date.
Key exclusion criteria
(1) Subjects who cannot continuously ingest research foods due to business trips etc. during the intake period.
(2) Subjects receiving treatment with insulin preparations.
(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 at the start of this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Futoshi |
| Middle name | |
| Last name | Nakamura |
Organization
NISSIN FOODS HOLDINGS CO., LTD.
Division name
Future Food Research & Development Division
Zip code
192-0001
Address
2100 Tobukimachi, Hachioji-shi, Tokyo
TEL
042-696-7606
futoshi.nakamura@nissin.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamichi |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department, Trial Planning Section
Zip code
162-0821
Address
1-8 Tsukudocho, Shinjuku-ku, Tokyo Kagurazaka AK Building 7F
TEL
090-4821-1099
Homepage URL
yamamichi.shingo578@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOOD PRODUCTS CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shintokai Yokohama Minoru Clinic Institutional Review Board
Address
1-13-8, Bessho, Minami-ku, Yokohama-city, Kanagawa
Tel
042-648-5551
yminoru-irb@eps.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 02 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056570
