UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a short-term low-carbohydrate diet on delayed onset muscle soreness and inflammation caused by eccentric exercise. :open-label,cross over trial
Title of the study (Brief title)	Effects of a short-term 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	Not applicable

Assessment
Primary outcomes	inflammatory marker(TNF-alpha/IL-6)in blood at the after eccentric exercise.
Key secondary outcomes	objective assessment of delayed onset muscle soreness due to eccentric exercise.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
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% Duration:six days
Interventions/Control_2	Tested material:high-carbohydrate diet Dosage:2300-2600kcal/day %carbohydrate:50-60% 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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	healthy young male
Key exclusion criteria	Subjects with / during treatment diseases / restrictive diet /allergens added to their food /administration of regular medication or supplements which affect this study /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	Yoshihiko Mano
Organization	Sendai University
Division name	Faculty of Physical Education
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	Yoshihiko Mano
Organization	Sendai University
Division name	Faculty of Physical Education
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	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 01 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 04 Day
Anticipated trial start date	2018 Year 01 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 09 Day
Last modified on	2018 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035072