UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039514 |
|---|---|
| Receipt number | 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 15:58:52 |
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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
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
yanagimoto.aya@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045048
