UMIN-CTR Clinical Trial

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	Completed
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 12 Month 09 Day

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