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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038612
Receipt No. 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 2019/11/18

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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
Email 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
Email ys-mano@sendai-u.ac.jp

Sponsor
Institute Sendai University
Institute
Department

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
Email 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 Preinitiation
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
2019 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044004

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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