UMIN-CTR Clinical Trial

Public title

Effect of collagen peptide intake on the leg pain onset in the training phase of long-distance runners

Acronym

The effect of collagen intake for long-distance runners

Scientific Title

Effect of collagen peptide intake on the leg pain onset in the training phase of long-distance runners

Scientific Title:Acronym

The effect of collagen intake for long-distance runners

Region

Japan

Condition

Healthy long-distance runners

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Mano

Organization

Josai University

Division name

Faculty of Pharmaceutical Sciences Department of Clinical Dietetics and Human Nutrition

Zip code

Address

1-1, Keyakidai, Sakado, Saitama, Japan

TEL

049-271-7246

Email

h-mano@josai.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Mano

Organization

Josai University

Division name

Faculty of Pharmaceutical Sciences Department of Clinical Dietetics and Human Nutrition

Zip code

Address

1-1, Keyakidai, Sakado, Saitama, Japan

TEL

049-271-7246

Homepage URL

Email

h-mano@josai.ac.jp

Institute

Nitta Gelatin Inc. Peptide Division.

Institute

Department

Personal name

Organization

Nitta Gelatin Inc.
Peptide Division.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Saitama Medical University

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

城西大学（埼玉県）（Josai University, Saitama）

Date of disclosure of the study information

2016

Year

07

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

04

Month

25

Day

Date of IRB

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

Other related information

Registered date

2016

Year

07

Month

05

Day

Last modified on

2017

Year

02

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026545