UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031529 |
|---|---|
| Receipt number | R000036002 |
| Scientific Title | Effect of Solubilized medium-chain triacylglycerols on energy metabolism |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2024/05/17 16:10:55 |
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Basic information
Public title
Effect of Solubilized medium-chain triacylglycerols on energy metabolism
Acronym
Effect of Solubilized medium-chain triacylglycerols on energy metabolism
Scientific Title
Effect of Solubilized medium-chain triacylglycerols on energy metabolism
Scientific Title:Acronym
Effect of Solubilized medium-chain triacylglycerols on energy metabolism
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of the test meal on exercise performance and energy metabolism of healthy adults have regular exercise habits.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood sugar level, blood ketone body, lactic acid level, respiratory quotient, the mileage
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
To take a supplement, if necessary with water.
Interventions/Control_2
To take a placebo, if necessary with water.
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Japanese male aged 20-39 at the screening visit.
2.Healthy adults.(no serious disease by self-report).
3.Those who do regular exercise habits.
4.Those who are able to sign an informed consent, after fully informed the purpose and contents of the study.
5.Those who are able to come to the hospital on the day of the study.
Key exclusion criteria
1.Those with serious or progressive diseases and symptoms, those with motor function disorders.
2.Currently under medications.
3.Severely damaged exerciser such as bone fracture, tendon rupture, muscle tear in the past year.
4.Those who are stopped to exercise by a doctor.
5.Those who do weight training everyday.
6.Smokers or those who quit smoking for less than 1 year.
7.Those who drink alcohol on the day before the study visit.
8.Those who with an abnormality in the blood test value at the time of screening, except for judged by the Principal doctor as physiological fluctuation range.
9.Those who are participated in other clinical trials within a month before the screening test.
10.Those who with any food or medicine allergies.
11.Those who judged to be inappropriate for participating in the study by Principal Investigator (or other doctor).
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kamioka |
Organization
NOF CORPORATION
Division name
FUNCTIONAL FOODS RESEARCH LABORATORY 3GROUP
Zip code
210-0865
Address
3-3 CHIDORI-CHO,KAWASAKI-KU,KAWASAKI,KANAGAWA ,JAPAN
TEL
044-281-2502
yuki_kamioka@nof.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kamioka |
Organization
NOF CORPORATION
Division name
FUNCTIONAL FOODS RESEARCH LABORATORY 3GROUP
Zip code
210-0865
Address
3-3 CHIDORI-CHO,KAWASAKI-KU,KAWASAKI,KANAGAWA ,JAPAN
TEL
044-281-2502
Homepage URL
yuki_kamioka@nof.co.jp
Sponsor or person
Institute
NOF CORPORATION
Institute
Department
Personal name
Funding Source
Organization
NOF CORPORATION
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
| 2018 | Year | 03 | Month | 01 | 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
| 2018 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 15 | 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
| 2018 | Year | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036002
