UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037196 |
|---|---|
| Receipt number | R000042404 |
| Scientific Title | An evaluation study for fat metabolism improving effect by single consumption of test beverage |
| Date of disclosure of the study information | 2020/06/29 |
| Last modified on | 2020/10/09 11:51:58 |
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Basic information
Public title
An evaluation study for fat metabolism improving effect by consumption of test food
Acronym
An evaluation study for fat metabolism improving effect by consumption of test food
Scientific Title
An evaluation study for fat metabolism improving effect by single consumption of test beverage
Scientific Title:Acronym
An evaluation study for fat metabolism improving effect by consumption of test food
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is dose setting of test food, for evaluation of fat metabolism improving effect by consumption of test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiration quotient
Key secondary outcomes
Fat oxidation
Energy expenditure
Incidence of adverse events and of side effects
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food A just before measuring metabolism by exhalation. Rest period (over 6 days). Intake of test food B just before measuring metabolism by exhalation. Rest period (over 6 days). Intake of control food just before measuring metabolism by exhalation.
Interventions/Control_2
Intake of test food B (200mL) just before measuring metabolism by exhalation. Rest period (over 6 days). Intake of control food just before measuring metabolism by exhalation. Rest period (over 6 days). Intake of test food A just before measuring metabolism by exhalation.
Interventions/Control_3
Intake of control food just before measuring metabolism by exhalation. Rest period (over 6 days). Intake of test food A just before measuring metabolism by exhalation. Rest period (over 6 days). Intake of test food B just before measuring metabolism by exhalation.
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy males aged 20 to 39 years old.
2) Males whose have no custom of exercise.
3) Males whose BMI ranges from 18.5 to 25.0
4) Males who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria
1) Males who have previous and/or current medical history of serious disease (e.g., circulatory organs, respiratory organs, digestive organs, urinary organs and endocrine organs).
2) Males who constantly use or who can't restrict use oral medicines (related to blood pressure, fatigue and fat metabolism) having a possibility of affecting test results.
3) Males who constantly use or who can't restrict use supplements, vitamins and nutrient (related to blood pressure, blood flow, exercise fatigue, metabolic improvement, fat burning or lipolysis) having a possibility of affecting test results.
4) Males who excessive alcohol intake.
5) Males who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study.
6) Males who have smoking habit.
7) Males who are severe anemia
8) Males who have previous medical history of drug and/or food allergy.
9) Males who donated over 200mL blood and/or blood components within the last one month to this study.
10) Males who donated over 400mL blood and/or blood components within the last three month to this study.
11) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
12) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Fujiwara |
Organization
CPCC Company Limited
Division name
Division of Clinical Research
Zip code
101-0047
Address
4F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
ASAHI QUALITY & INNOVATIONS, LTD.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
| 2020 | Year | 06 | 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
| 2019 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 27 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042404
