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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041166
Receipt No. 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 2020/07/20

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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
Email 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
Email ishihara@flexibleinc.jp

Sponsor
Institute Kitasato Institute Hospital
Institute
Department

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
Email 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
2020 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047004

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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