UMIN-CTR Clinical Trial

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