UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041166 |
|---|---|
| Receipt number | R000047004 |
| Scientific Title | The Effect of Nutritional Support by Registered Dietitians and Pharmacists in Dispensation Pharmacy For the Specific Health Guidance in Japan |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2021/05/07 07:26:36 |
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Basic information
Public title
The Effect of Nutritional Support by Registered Dietitians and Pharmacists in Dispensation Pharmacy For the Specific Health Guidance in Japan
Acronym
The Effect of Nutritional Support by Registered Dietitians and Pharmacists in Dispensation Pharmacy For the Specific Health Guidance in Japan
Scientific Title
The Effect of Nutritional Support by Registered Dietitians and Pharmacists in Dispensation Pharmacy For the Specific Health Guidance in Japan
Scientific Title:Acronym
The Effect of Nutritional Support by Registered Dietitians and Pharmacists in Dispensation Pharmacy For the Specific Health Guidance in Japan
Region
| Japan |
Condition
Condition
metabolic syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine how the components of metabolic syndrome can be changed by dietary interventions by registered dietitians in a dispensing pharmacy for individuals who meet two or more of the diagnostic criteria for metabolic syndrome in a specific health checkup at practical doctors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk values for developing diabetes by using the diabetes risk prediction tool(J-ECOH study)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A dietitian will provide low-carbohydrate diet interventions for 5 to 30 minutes each time in a dispensing pharmacy, about once a week for 12 weeks.
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Abdominal girth >= 85cm (male) or 90 cm (female) or BMI >= 25
2)Fasting blood glucose level >= 100 mg/dl or HbA1c >=5.6%
3)Systolic blood pressure >= 130 mmHg or diastolic blood pressure >= 85 mmHg
4)Fasting triglyceride level >= 150 mg/dl or HDL-C < 40 mg/dl
Key exclusion criteria
1)Diabetic patients receiving more than 1/2 of the maximum insurable dose of sulfonylurea
2)Diabetic patients receiving more than 25 units of injectable insulin per day
3)Type 1 diabetics or diabetics with insulin dependent conditions patients
4)Patients who started a new or increased dose of diabetes medication within 3 months of obtaining consent
5)Patients who started a new or increased dose of hypertension medication within 3 months of obtaining consent
6)Patients who started a new or increased dose of a hyperlipidemic drug within 3 months of obtaining consent
7)Patients who are pregnant, lactating, possibly pregnant, or expecting
8)Patients who have a malignancy or a history of malignant treatment within 12 months of obtaining consent
9)Other patients who are deemed inappropriate by the principal investigator
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Yamada |
Organization
Kitasato Institute Hospital
Division name
DiabateCenter
Zip code
108-8642
Address
5-9-1 Shirogane,Minato-ku
TEL
03-3444-6161
yamada-s@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ishihara |
Organization
Flexible inc
Division name
CEO
Zip code
1500043
Address
2-10-10, Dogenzaka Shibuya-ku
TEL
0364553055
Homepage URL
ishihara@flexibleinc.jp
Sponsor or person
Institute
Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Eat & Fun Health Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato Institute Hospital
Address
5-9-1 Shirogane,Minato-ku
Tel
03-3444-6161
kenkyu@insti.kitasato-u.ac.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
| 2020 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 20 | Day |
Last modified on
| 2021 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047004
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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