UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047413 |
|---|---|
| Receipt number | R000053944 |
| Scientific Title | The effect of beverage consumption on diet induced thermogenesis |
| Date of disclosure of the study information | 2022/04/11 |
| Last modified on | 2023/04/11 09:21:59 |
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Basic information
Public title
The effect of beverage consumption on diet induced thermogenesis
Acronym
The effect of beverage consumption on diet induced thermogenesis
Scientific Title
The effect of beverage consumption on diet induced thermogenesis
Scientific Title:Acronym
The effect of beverage consumption on diet induced thermogenesis
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of fruit juice consumption on diet-induced thermogenesis in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of diet-induced thermogenesis and energy expenditure after 4 weeks of consumption of the test beverage
Key secondary outcomes
1) Change of body composition after 4 weeks of consumption of the test beverage
2) Change of oxygen consumption, carbohydrate oxidation, lipid oxidation and respiratory quotient after 4 weeks of consumption of the test beverage
3) Change in body experience index after 4 weeks of consumption of the test beverage
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
Intake of 100ml of test beverage for 4 weeks
Interventions/Control_2
Intake of 100ml of placebo beverage for 4 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Male and female over 20 years old
2) Healthy persons, free of chronic diseases3) BMI greater than 18.5 and less than 25.0
4) Subjects who have given their written consent to participate in the research
Key exclusion criteria
1) Subjects who have some kind of illness and are being treated with drugs
2) Subjects who have allergic diseases
3) Subjects who regularly use health foods such as supplements during the study period
4) Shubject who consume excessive amounts of polyphenol-containing foods during the study period
5) Subjects who plan to make significant changes in their lifestyle, such as exercise habits, work, or schoolwork, during the study period.
6) Pregnant woman
5) Subjects who are judge as unsuitable for the study by the investigator
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Ippei |
| Middle name | |
| Last name | Shimizu |
Organization
Juntendo University
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8421
Address
2-1-1 Hongo Bunkyoku Tokyo, Japan
TEL
03-3813-3111
s.shimizu@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Furuuchi |
Organization
Bourbon corporation
Division name
Advanced research institutes
Zip code
956-0841
Address
316-2 Higashijima, Akiha-ku, Niigata
TEL
0250-25-1296
Homepage URL
furuuchi-ryo@bourbon.co.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Bourbon corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Niigata University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Commiittee, Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
hongo-rinri@juntendo.ac.jp
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
| 2022 | Year | 04 | Month | 11 | 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
22
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
| 2022 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2022 | Year | 04 | Month | 06 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053944
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
