UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019884
Receipt number R000022972
Scientific Title A study for an effect of energy metabolism after repeated ingestion of drinks containing plant polyphenols
Date of disclosure of the study information 2015/11/29
Last modified on 2019/12/26 16:41:52

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A study for an effect of energy metabolism after repeated ingestion of drinks containing plant polyphenols

Acronym

Effect of polyphenols on energy metabolism

Scientific Title

A study for an effect of energy metabolism after repeated ingestion of drinks containing plant polyphenols

Scientific Title:Acronym

Effect of polyphenols on energy metabolism

Region

Japan


Condition

Condition

Healthy male subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effect of repeated ingestion of drinks containing plant polyphenols on energy expenditure and substrate utilization.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Twenty-four-hour fat oxidation

Key secondary outcomes

Twenty-four-hour energy expenditure, diet-induced thermogenesis, activity-induced thermogenesis, sleeping metabolic rate, basal metabolic rate, fasting blood metabolites and dietary fat oxidation


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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Placebo drink 4 weeks consumption > wash out 4 weeks > Active drink 4 weeks consumption

Interventions/Control_2

Active drink 4 weeks consumption > wash out 4 weeks > Placebo drink 4 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

59 years-old >=

Gender

Male

Key inclusion criteria

1.Aged between 20 and 59
2.BMI >= 18.5 and =<29.9 kg/m2
3.Person who provides informed consent by a document

Key exclusion criteria

1. Person who is difficult to participate the study due to dysfunctions of liver, kidney, heart, respiration, endocrine, metabolism, nervous system, consciousness or diabetes, or the other dysfunctions.
2. Person who takes medication for glucose or fat metabolism, or hypertension.
3. Person had allergy against any constituents in the test diet.
4. Smoker
5. Shift worker
6. Heavy drinker (30g alcohol per day)
7. Person who are considered inappropriate by medical doctors.

Target sample size

16


Research contact person

Name of lead principal investigator

1st name Osaki
Middle name
Last name Noriko

Organization

KAO CORPORATION

Division name

Health Care Food Research Labs

Zip code

131-8501

Address

2-1-3 Bunka, Sumida-ku Tokyo

TEL

03-5630-7266

Email

osaki.noriko@kao.co.jp


Public contact

Name of contact person

1st name Masanobu
Middle name
Last name Hibi

Organization

KAO CORPORATION

Division name

Health Care Food Research Labs

Zip code

131-8501

Address

2-1-3 Bunka, Sumida-ku Tokyo

TEL

03-5630-7266

Homepage URL


Email

hibi.masanobu@kao.co.jp


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

IRB on JCCR

Address

2-27-17, Minami-ikebukuroToshima-ku

Tel

03-6868-7022

Email

jccr-info@cts-smo.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

花王株式会社(東京都)
チヨダパラメディカルケアクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 29 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

Terminated

Date of protocol fixation

2015 Year 11 Month 26 Day

Date of IRB

2015 Year 11 Month 26 Day

Anticipated trial start date

2015 Year 11 Month 30 Day

Last follow-up date

2016 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 20 Day

Last modified on

2019 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022972


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name