UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023033
Receipt number R000026545
Scientific Title Effect of collagen peptide intake on the leg pain onset in the training phase of long-distance runners
Date of disclosure of the study information 2016/07/07
Last modified on 2017/02/03 08:43:05

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Basic information

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

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

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


Public contact

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


Sponsor or person

Institute

Nitta Gelatin Inc. Peptide Division.

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name