UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053144 |
|---|---|
| Receipt number | R000060652 |
| Scientific Title | Evaluation of effects induced by ingesting test foods on fat oxidation at rest. |
| Date of disclosure of the study information | 2023/12/18 |
| Last modified on | 2023/12/18 14:44:41 |
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Basic information
Public title
Evaluation of effects induced by ingesting test foods on fat oxidation at rest.
Acronym
Evaluation of effects induced by ingesting test foods on fat oxidation at rest.
Scientific Title
Evaluation of effects induced by ingesting test foods on fat oxidation at rest.
Scientific Title:Acronym
Evaluation of effects induced by ingesting test foods on fat oxidation at rest.
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify some kind of effect of a single intake of the food ingredient on fat oxidation at rest under fasting and food intake conditions for male subjects ranging in age from 20 to 50 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fat oxidation
Key secondary outcomes
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
To begin with, subjects will take the food-1 once a day. After more than 5 days of washout period, subjects will take the food-2 once a day.
Interventions/Control_2
To begin with, subjects will take the food-2 once a day. After more than 5 days of washout period, subjects will take the food-1 once a day.
Interventions/Control_3
To begin with, subjects will take the food-1 and test food once a day. After more than 5 days of washout period, subjects will take the food-2 and test-food once a day.
Interventions/Control_4
To begin with, subjects will take the food-2 and test food once a day. After more than 5 days of washout period, subjects will take the food-1 and test-food once a day.
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
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Male subjects ranging in age from 20 to 49 at informed consent.
(2) Subjects ranging in BMI from 18.5 to less than 25.0 kg/m2.
(3) Subjects who can visit the designated facility on measurement days.
(4) Subjects who can make self-judgment and voluntarily gave written informed consent.
Key exclusion criteria
(1) Subjects who have a habit of exercises.
(2) Subjects who can not brethe naturally using an aeromonitor.
(3) with irregular life rhythm (e.g., irregular shift work).
(4) Subjects having habitual alcohol intake.
(5) Subjects having a habit of smoking.
(6) Subjects having irregular eating habits.
(7) Subjects with dieting or planning to diet during this study.
(8) Subjects having serious allergic rhinitis.
(9) Subjects who have periodically used health-specific / functional / health foods including supplements, which might affect fat metabolism.
(10) Subjects who take affecting medicines (except non affecting painkiller/anti-inflammatory/external/eyedrops) within a month before the consent.
(11) Subjects having severe anemia
(12) Subjects who have experience illness or deterioration of physical condition due to blood sampling in the past.
(13) Subjects who have difficulty in having blood drawn from a peripheral blood vein.
(14) Subjects with a maximal blood pressure of less than 90 mmHg.
(15) Subjects who donated their blood components and/or whole blood (0.2 L) within the past 4 weeks.
(16) Subjects who donated their whole blood (0.4 L) within the past 12 weeks.
(17) Subjects being collected in total of their blood (1.2 L) within the past 12 months and in this research.
(18) Subjects being under other clinical tests, or partook in those within the past four weeks, or will join those after the consent.
(19) Subjects who meet any of the following:
(a) suffering from heart, liver, or kidney disease (including complications of other diseases)
(b) having a history of cardiovascular disease
(c) diabetes
(d) allergic to the test food and required one.
(20) Others who were judged as inappropriate for participation by the principal/sub investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Minami |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
2110067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
05017346161
Hisako_Nakamura@suntory.co.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Sato |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
2110067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1734-6161
Homepage URL
Mariko_Sato@suntory.co.jp
Sponsor or person
Institute
CPCC Company Limited.
Institute
Department
Personal name
Funding Source
Organization
Suntory beverage & Food limited.
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 Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
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
| 2023 | Year | 12 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 18 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060652
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