UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of collagen peptide intake on the leg pain onset in the training phase of long-distance runners
Title of the study (Brief title)	The effect of collagen intake for long-distance runners
Region	Japan

Condition
Condition	Healthy long-distance runners
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to reveal whether Collagen Peptide that has reduce suppressive and symptoms of leg pain in athletes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	JKOM Score
Key secondary outcomes	1. Anthropometric (height, weight, upper arm perimeter, triceps subcutaneous fat thickness, biceps subcutaneous fat thickness, fat thickness under the shoulder blades, thigh perimeter, anterior thigh fat thickness, BMI, body fat mass, blood pressure) 2. Diet survey (using a self-administered diet history questionnaire with a validity study in Japanese, to assess energy, nutrients such as protein, meat, fish, the intake of food groups, such as beverages) 3. Lifestyle survey (smoking habits, sleep habits, physical activity status, to evaluate exercise history, medical history, medication situation, the presence or absence of a food allergy) 4. Blood tests (general blood test item, inflammation-related marker, to measure the blood levels of the tissue matrix metabolic-related biomarkers) 5. Ultrasonic echo test (to measure the tissue thickness, such as the Achilles tendon and plantar fascia) 6. Activity Survey (for training, such as mileage, ingestion situation of the test diet, to record the therapeutic situation for the leg pain) 7. Occurrence of leg pain (1 year) (the affected area and symptoms, the treatment method, recording the time it took to return)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intervention: Intake 5g collagen peptide for 60 days
Interventions/Control_2	Control: Intake 5g Dextrin for 60days
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	- Over 18 years old - Male - People who constantly train with mechanical stress
Key exclusion criteria	That apply to one or more are excluded from the subject of the present study. 1. who is diabetes or abnormalities in diabetes or HbA1c 2. who has a serious disease history 3. who shows the abnormal values of liver and kidney function 4.who shows a failure in cardiopulmonary function 5. who has a food allergy to pork and gelatin 6. who undergone the surgery of the digestive tract 7. who was diagnosed with chronic or acute infection by physician's discretion 8. who is participating in other clinical trials at the start of the study 9. who continually ingest collagen within the past 3 months 10. who has a continuous intake of supplements for the purpose of joint pain improved within the past 3 months 11. who was determined as the inappropriate by investigators 12. who is smoker 13. who has habit of taking excessive alcohol
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroshi Mano
Organization	Josai University
Division name	Faculty of Pharmaceutical Sciences Department of Clinical Dietetics and Human Nutrition
Address	1-1, Keyakidai, Sakado, Saitama, Japan
TEL	049-271-7246
Email	h-mano@josai.ac.jp

Public contact
Name of contact person	Hiroshi Mano
Organization	Josai University
Division name	Faculty of Pharmaceutical Sciences Department of Clinical Dietetics and Human Nutrition
Address	1-1, Keyakidai, Sakado, Saitama, Japan
TEL	049-271-7246
Homepage URL
Email	h-mano@josai.ac.jp

Sponsor
Institute	Nitta Gelatin Inc. Peptide Division.
Institute
Department

Funding Source
Organization	Nitta Gelatin Inc. Peptide Division.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Saitama Medical University
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	城西大学（埼玉県）（Josai University, Saitama）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 25 Day
Anticipated trial start date	2016 Year 07 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 07 Month 05 Day
Last modified on	2017 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026545