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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043836
Receipt No. R000050029
Scientific Title Influence on physical condition by "healthy meal" intake on males with high blood glucose
Date of disclosure of the study information 2021/04/04
Last modified on 2021/04/05

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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


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