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 |
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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 | 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
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
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
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
