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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042419
Receipt No. R000048423
Scientific Title Effect of coffee bean extract on postprandial blood glucose level
Date of disclosure of the study information 2020/11/11
Last modified on 2020/11/11

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Basic information
Public title Effect of coffee bean extract on postprandial blood glucose level
Acronym Effect of coffee bean extract on postprandial blood glucose level
Scientific Title Effect of coffee bean extract on postprandial blood glucose level
Scientific Title:Acronym Effect of coffee bean extract on postprandial blood glucose level
Region
Japan

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

Objectives
Narrative objectives1 To assess the effect of coffee bean extract on postprandial blood glucose level.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Postprandial blood glucose level up to 2 hours after intake
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Breakfast containing coffee bean extract
Interventions/Control_2 Breakfast without coffee bean extract
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
25 years-old >=
Gender Male
Key inclusion criteria 1. Aged 20 to 25 years old
2. Body mass index less than 30 kg/m2
3. Healthy condition enough to complete the intervention safely
4. Subject who voluntarily participates with written consent
Key exclusion criteria 1. Subject who has glucose metabolism disorders, endocrine disorders, kidney/liver and digestive organ diseases.
2. Subject who has prescribed drugs.
3. Subject diagnosed to have cardiovascular disorder.
4. Subject who has type 1 or type 2 diabetes mellitus.
5. Subject who was judged to have symptom needed to treat or reexamine at health check within a year.
6. Subject who participated in another trial within 3 months.
7. Subject who took illegal drug within 6 months.
8. Subject who was addicted to alcohol or other drug within 6 months
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Yoshio
Middle name Suzuki
Last name Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code 2701695
Address 1-1, Hiragagakuendai, Inzai, Chiba
TEL +81476981001
Email yssuzuki@juntendo.ac.jp

Public contact
Name of contact person
1st name Yoshio
Middle name
Last name Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code 2701695
Address 1-1, Hiragagakuendai, Inzai, Chiba
TEL +81476981001
Homepage URL
Email yssuzuki@juntendo.ac.jp

Sponsor
Institute Juntendo University, Graduate School of Health & Sports Science
Institute
Department

Funding Source
Organization self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee of Juntendo University Graduate School of Sports and Health Science
Address 1-1, Hiragagakuendai, Inzai, Chiba
Tel +81476981001
Email sc-kyomu@juntendo.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 順天堂大学(千葉県)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 11 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
2020 Year 11 Month 10 Day
Date of IRB
2020 Year 11 Month 10 Day
Anticipated trial start date
2020 Year 11 Month 10 Day
Last follow-up date
2020 Year 12 Month 28 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 11 Month 11 Day
Last modified on
2020 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048423

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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