NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy long-distance runners
Date of first enrollment	2016/07/07
Target sample size	60
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Intervention: Intake 5g collagen peptide for 60 days Control: Intake 5g Dextrin for 60days

Outcome(s)

Primary Outcome

JKOM Score

Secondary Outcome

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)

Key inclusion & exclusion criteria

Age minimum	18years-old
Age maximum	Not applicable
Gender	Male
Include criteria
Exclude 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