UMIN-CTR Clinical Trial

Basic information
Public title	Influence on physical condition by "healthy meal" intake on males with high blood glucose
Acronym	Influence on physical condition by "healthy meal" intake on males with high blood glucose
Scientific Title	Influence on physical condition by "healthy meal" intake on males with high blood glucose
Scientific Title:Acronym	Influence on physical condition by "healthy meal" intake on males with high blood glucose
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the change on physical condition by "healthy meal" intake
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c, fasting blood glucose at 4 week test
Key secondary outcomes	Blood glucose / insulin level after 75 g OGTT, each change amount, area under the concentration time curve (blood glucose / insulin AUC), blood glucose peak value (blood glucose / insulin Cmax), insulin, HOMA-IR, adiponectin, insulin, HOMA-beta at 4 week test

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	Intake "healthy meal" for 20 days
Interventions/Control_2	Eat usual meal
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	30 years-old <=
Age-upper limit	64 years-old >=
Gender	Male
Key inclusion criteria	1) Males aged between 30 and 64 2) Subjects who equal to or more than 5.6 % of HbA1c 3) Among the subjects who met the inclusion criteria 1) and 2), select from the subjects with high fasting blood glucose
Key exclusion criteria	1) Subjects who are unable to continuously intake "healthy meal" during intake period 2) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and the results of preliminary examination 3) Subjects who are judged as unsuitable for the study based on the medical history 4) Subjects with food allergies 5) Subjects who have difficulty in treatment by participating in the study 6) Subjects who are receiving treatment or use equipment that affects the examination 7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 8) Subjects who have participated in other clinical study prior to the current study 9) Subjects who routinely take health foods that may affect the results 10) Subjects who regularly consume large amount of alcohol 11) Subjects who smoke excessively (more than 21 cigarettes a day) 12) Subjects with extremely irregular diet 13) Subjects with irregular life rhythms 14) Subjects who undergoes a medical examination from 2 weeks before the preliminary examination and the end of the study 15) Subjects who plan to donate blood during the study period 16) Subjects who judged as unsuitable for the study by the investigator for other reasons
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Yamato
Organization	Medical Corporation Kouwakai Kouwa Clinic
Division name	Internal medicine, Director
Zip code	170-0003
Address	6-33-17, Komagome, Toyoshima-ku, Tokyo
TEL	03-3917-8105
Email	info@kouwakai.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Nakagawa
Organization	EP Mediate Co., Ltd.
Division name	Development Business Headquarters, TTC Center, Trial Planning Department
Zip code	162-0822
Address	Turuya Bldg.,2-23, Shimomiyabicho, Shinjuku-ku, Tokyo
TEL	03-5657-4983
Homepage URL
Email	nakagawa768@eps.co.jp

Sponsor
Institute	EP Mediate Co., Ltd.
Institute
Department

Funding Source
Organization	non-disclosure
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	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguro-ku, Tokyo
Tel	03-6452-2712
Email	saito876@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	2021 Year 04 Month 04 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	Open public recruiting
Date of protocol fixation	2021 Year 03 Month 25 Day
Date of IRB	2021 Year 03 Month 25 Day
Anticipated trial start date	2021 Year 04 Month 05 Day
Last follow-up date	2021 Year 07 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 04 Day
Last modified on	2021 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050029

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.