UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000039514
Receipt No. R000045048
Scientific Title Effects of combined consumption of catechins and chlorogenic acids on postprandial glucose, insulin, incretin response and insulin sensitivity in healthy men: a randomized, double-blind, placebo-controlled crossover trial
Date of disclosure of the study information 2020/02/29
Last modified on 2020/02/17 (Ver. 2)

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Basic information
Public title Effects of combined consumption of catechins and chlorogenic acids on postprandial glucose, insulin, incretin response and insulin sensitivity in healthy men: a randomized, double-blind, placebo-controlled crossover trial
Acronym Effects of combined consumption of catechins and chlorogenic acids [n2016003]
Scientific Title Effects of combined consumption of catechins and chlorogenic acids on postprandial glucose, insulin, incretin response and insulin sensitivity in healthy men: a randomized, double-blind, placebo-controlled crossover trial
Scientific Title:Acronym Effects of combined consumption of catechins and chlorogenic acids [n2016003]
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of efficacy of combinational intake of catechins and chlorogenic acids on glucose metabolism
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood glucose
Key secondary outcomes Insulin, GLP-1, GIP, HOMA-R, Matsuda Index

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Control food 3 weeks consumption > wash out 2 weeks > test food 3 weeks consumption
Interventions/Control_2 Test food 3 weeks consumption > wash out 2 weeks > control food 3 weeks consumption
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
Key inclusion criteria (1) Age >= 20 and < 60years
(2) Subjects who have given written informed consent prior to start of study
Key exclusion criteria (1) Subjects having diabetes
(2) Subjects who have a history or signs of a heart or cerebrovascular disease
(3) Subjects having diabetes, a liver, kidney or respiratory disease, endocrine disorder, metabolic disorder, organ disorder, gout, rheumatism, autoimmune disease, allergy disease, mental disorder, cancer, infection disease, or other diseases
(4) Subjects who take an antidiabetic drug or antihyperlipidemic drug
(5) Subjects having thyroid deficiency
(6) Subjects who have a smoking habit
(7) Heavy drinker
(8) Subjects who have donated over 200 mL of blood within the last one month prior to the current study or over 400 mL of blood within the last three months prior to the study
(9) Subjects who have severe anemia (Hb <=7 g/dL)
(10) Subjects who have allergic reaction to food
(11) Subjects who are judged to be inappropriate for the study by the medical doctor or investigator for other reason
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Noriko
Middle name
Last name Osaki
Organization Kao Corporation
Division name Health & Wellness Products Research Laboratories
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL 03-5630-7265
Email osaki.noriko@kao.com

Public contact
Name of contact person
1st name Aya
Middle name
Last name Yanagimoto
Organization Kao Corporation
Division name Biological Science Research laboratories
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL 03-5630-7476
Homepage URL
Email yanagimoto.aya@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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 Human Research Ethics Committee, Kao Corporation
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
Tel 03-5630-7263
Email morisaki.naoko@kao.com

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
2020 Year 02 Month 29 Day

Related information
URL releasing protocol Unpublished due to the protocol including the intellectual property rights
Publication of results Published

Result
URL related to results and publications works in progress
Number of participants that the trial has enrolled 11
Results 
A significant difference was observed in the primary outcome.
Results date posted
2020 Year 02 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Healthy adults
Participant flow 
11 participants completed and 11 subjects were incorporated into the analyses
Adverse events 
No adverse effect reported
Outcome measures 
Blood glucose
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 09 Month 08 Day
Date of IRB
2016 Year 09 Month 08 Day
Anticipated trial start date
2016 Year 09 Month 26 Day
Last follow-up date
2016 Year 12 Month 08 Day
Date of closure to data entry
2017 Year 01 Month 17 Day
Date trial data considered complete
2017 Year 01 Month 20 Day
Date analysis concluded
2017 Year 01 Month 23 Day

Other
Other related information

Management information
Registered date
2020 Year 02 Month 17 Day
Last modified on
2020 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045048