UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049163 |
|---|---|
| Receipt number | R000056000 |
| Scientific Title | Influence of ingestion of structured lipids on muscle fatigue and muscle endurance: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2022/10/08 |
| Last modified on | 2023/04/08 10:25:51 |
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Basic information
Public title
Influence of ingestion of structured lipids on muscle fatigue and muscle endurance: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym
Effect of structured lipids on muscle fatigue/muscle endurance
Scientific Title
Influence of ingestion of structured lipids on muscle fatigue and muscle endurance: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
Effect of structured lipids on muscle fatigue/muscle endurance
Region
| Japan |
Condition
Condition
muscle fatigue/muscle endurance
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the influence of structured lipids for muscle fatigue/muscle endurance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After ingestion of tested materials for 8 weeks, subjects perform resistance training with elbow flexors. Before and after resistance training,
1) maximal isometric contraction torque
2) range of motion
3) rate of perceived exertion (RPE)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Tested material: structured lipids
Dosage: 4.56g/day
Duration: 8 weeks
Interventions/Control_2
Tested material: placebo oil
Dosage: 4.56g/day
Duration: 8 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
| 18 | years-old | <= |
Age-upper limit
| 999 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male subjects
Key exclusion criteria
Subjects with
/resistance training more than five times a week for a year /no resistance training or exercise during over a year /serious liver, kidney, heart, respiratory, endocrine or metabolic diseases/ scheduled for surgery during this study/ administration of regular medication/ regular administration of supplements which affect this study / food allergies/ participation of other clinical trial during this study/ restriction of exercise/ any reason in the opinion of the lead principal investigator not to take part in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Ochi |
Organization
Hosei University
Division name
Faculty of Bioscience and Applied Chemistry
Zip code
184-0084
Address
3-7-2 Kajino, Koganei, Tokyo
TEL
042-387-6337
ochi@hosei.ac.jp
Public contact
Name of contact person
| 1st name | Eisuke |
| Middle name | |
| Last name | Ochi |
Organization
Hosei University
Division name
Faculty of Bioscience and Applied Chemistry
Zip code
184-0084
Address
3-7-2 Kajino, Koganei, Tokyo
TEL
042-387-6337
Homepage URL
ochi@hosei.ac.jp
Sponsor or person
Institute
Hosei University
Institute
Department
Personal name
Funding Source
Organization
Nippon Suisan Kaisha 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
Hosei University Sports Research Center IRB
Address
4342, Aihara, Machida, Tokyo
Tel
042-783-2076
tamata@hosei.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 | 10 | Month | 08 | 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
20
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 | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 13 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 08 | Day |
Last modified on
| 2023 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056000
| 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 |
