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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000031529 |
Receipt No. | 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 | 2018/03/26 |
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 |
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Condition | ||
Condition | Healthy adults | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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). |
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Target sample size | 4 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | NOF CORPORATION | ||||||
Division name | FUNCTIONAL FOODS RESEARCH LABORATORY 3GROUP | ||||||
Zip code | |||||||
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 |
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Organization | NOF CORPORATION | ||||||
Division name | FUNCTIONAL FOODS RESEARCH LABORATORY 3GROUP | ||||||
Zip code | |||||||
Address | 3-3 CHIDORI-CHO,KAWASAKI-KU,KAWASAKI,KANAGAWA ,JAPAN | ||||||
TEL | 044-281-2502 | ||||||
Homepage URL | |||||||
yuki_kamioka@nof.co.jp |
Sponsor | |
Institute | NOF CORPORATION |
Institute | |
Department |
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 | |
Address | |
Tel | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036002 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |