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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019884
Receipt No. 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 2019/08/23

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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
Middle name
Last name Noriko Osaki
Organization KAO CORPORATION
Division name Health Care Food Research Labs
Zip code
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
Middle name
Last name Masanobu Hibi
Organization KAO CORPORATION
Division name Health Care Food Research Labs
Zip code
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
Address
Tel
Email

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 Completed
Date of protocol fixation
2015 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 30 Day
Last follow-up date
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 08 Month 23 Day


Link to view the page
URL(English) https://upload.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


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