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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045048


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name