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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038152
Receipt No. 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

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Basic information
Public title Effects of health programs on blood glucose and blood pressure
Acronym Effects of health programs on blood glucose and blood pressure
Scientific Title Effects of health programs on blood glucose and blood pressure
Scientific Title:Acronym Effects of health programs on blood glucose and blood pressure
Region
Japan

Condition
Condition Adult males and females
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the effects of health programs that support test food intake on blood glucose and blood pressure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood glucose and HbA1c
Blood pressure
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Previous observation (2 weeks)-Intake of test foods (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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria (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
Key exclusion criteria (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
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Satoki
Middle name
Last name Homma
Organization Saitama Medical Center
Division name Health management center
Zip code 3300074
Address 4-9-3, Kitaurawa, Urawa-ku, Saitama-shi, Saitama
TEL 0569-24-5139
Email rintaro.kishi@welby.jp

Public contact
Name of contact person
1st name Rintaro
Middle name
Last name Kishi
Organization Welby Inc.
Division name Research Development Office
Zip code 1030023
Address Toushou Bldg. 5F, 3-8-3, Nihonbashi Honchou, Chuo-ku, Tokyo
TEL 03-6206-2937
Homepage URL
Email rintaro.kishi@welby.jp

Sponsor
Institute Welby Inc.
Institute
Department

Funding Source
Organization Mizkan Holdings 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 The Ethics Committee of Ueno-Asagao Clinic
Address Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015
Tel 03-6240-1162
Email jimukyoku@tes-h.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
2019 Year 10 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 20
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 Completed
Date of protocol fixation
2019 Year 09 Month 02 Day
Date of IRB
2019 Year 09 Month 11 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2020 Year 01 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
2019 Year 09 Month 30 Day
Last modified on
2020 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043462

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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