UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038612 |
|---|---|
| Receipt number | R000044004 |
| Scientific Title | Effects of a short-term low-carbohydrate diet on delayed onset muscle soreness and inflammation caused by eccentric exercise. :open-label,cross over trial |
| Date of disclosure of the study information | 2019/12/05 |
| Last modified on | 2023/09/21 15:15:38 |
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Basic information
Public title
Effects of a short-term low-carbohydrate diet on delayed onset muscle soreness and inflammation caused by eccentric exercise
Acronym
Effects of low-carbohydrate diet on delayed onset muscle soreness
Scientific Title
Effects of a short-term low-carbohydrate diet on delayed onset muscle soreness and inflammation caused by eccentric exercise. :open-label,cross over trial
Scientific Title:Acronym
Effects of low-carbohydrate diet on delayed onset muscle soreness and inflammation caused by eccentric exercise.
Region
| Japan |
Condition
Condition
delayed onset muscle soreness
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the effectiveness of a short-term low-carbohydrate diet in the alleviation of delayed onset muscle soreness and inflammation caused by eccentric exercise in healthy young males.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
objective assessment of delayed onset muscle soreness due to eccentric exercise.
Key secondary outcomes
inflammatory markaer (TNF-alpha/IL-1)in blood at the after excentric exercise.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Tested material:low-carbohydrate diet
Dosage:2300-2600kcal/day
%carbohydrate:<20%,%fat:over 60%
Duration:six days
Interventions/Control_2
Tested material:nomal diet
Dosage:2300-2600kcal/day
%carbohydrate:50-60%,%fat:<30%
Duration:six days
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
healthy young male
Key exclusion criteria
Subjects with
/ during treatment diseases / restrictive diet /allergens added to their food /any reason in the opinion of the lead principal investigator not to be taken part in this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Mano |
Organization
Sendai University
Division name
Faculty of Physical Education
Zip code
989-1693
Address
2-2-18 Funaokaminami, Shibata-cho, Shibata-gun, Miyagi, Japan
TEL
0224-55-1389
ys-mano@sendai-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Mano |
Organization
Sendai University
Division name
Faculty of Physical Education
Zip code
989-1693
Address
2-2-18 Funaokaminami, Shibata-cho, Shibata-gun, Miyagi, Japan
TEL
0224-55-1389
Homepage URL
ys-mano@sendai-u.ac.jp
Sponsor or person
Institute
Sendai University
Institute
Department
Personal name
Funding Source
Organization
Sendai University
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
Sendai University
Address
2-2-18 Funaokaminami, Shibata-cho, Shibata-gun, Miyagi, Japan
Tel
0224-55-1036
soumu@sendai-u.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
仙台大学体育学部（宮城県）
（Sendai University Faculty of Physical Education）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 05 | 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
| 2019 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 18 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044004
| 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 |
