UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022972