UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058484 |
|---|---|
| Receipt number | R000066864 |
| Scientific Title | Influence of ingestion of Krill oil on sports performance: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2025/07/15 |
| Last modified on | 2025/07/15 23:03:51 |
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Basic information
Public title
Influence of ingestion of Krill oil on sports performance: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym
Effect of Krill oil on sports performance
Scientific Title
Influence of ingestion of Krill oil on sports performance: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
Effect of Krill oil on sports performance
Region
| Japan |
Condition
Condition
lower limb muscle strength
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the sports performance of Krill Oil ingested subjects when they perform exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
lower limb muscle strength
Key secondary outcomes
-Body composition
-Muscle physiology and morphology
-Performance measures
Max isometric torque (MVC), RFD, jump height (CMJ, RJ), ability to change direction (COD)
-Cognitive function Using Go/No Go task Executive function using Go/No-Go tasks
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Test diet: Krill oil
Dose: 1 g/day
Duration: 3 weeks
Interventions/Control_2
Test diet: placebo
Dose: 1 g/day
Duration: 3 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
| Not applicable |
Gender
Female
Key inclusion criteria
Athletes who are in good health
Athletes who belong to the V-League
Key exclusion criteria
Persons with serious liver, renal, cardiac, respiratory, endocrine, or metabolic diseases
Persons scheduled for surgery during the study period
Persons who regularly use medicines
Persons who routinely consume foods that may affect study results
Persons with food allergies
Persons participating in other clinical trials
Persons with exercise restrictions
Clinical personnel who are judged by the principal investigator to be inappropriate to participate in this study.
Target sample size
15
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
1848584
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
1848584
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
NA
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sendai Shirayuri Women's College
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sendai Shirayuri Women's College
Address
6-1, Honda-cho, Izumi-ku, Sendai-shi, Miyagi
Tel
022-374-5048
t-ohkubo@sendai-shirayuri.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
| 2025 | Year | 07 | Month | 15 | 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
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066864
