Functional Food Application of Okara Protein Hydrolysate (OPH)- for Anti-exercise-fatigue

Healthy Clinical Trial

Official title:

Functional Food Application of Okara Protein Hydrolysate (OPH)- for Anti-exercise-fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05000918
• Other study ID #: CS2-20042
• Status: Completed
• Phase: N/A
• Start date: July 17, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: August 2021
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the anti-exercise-fatigue effects of okara protein hydrolysate (OPH) in men

Description:

Each subject must undergo a cardiopulmonary capacity test to assess the maximum oxygen uptake 1 week before the intervention (day 1), and then eat the test food for 4 weeks (day 8 to day 35). Before and after the intervention (the 8th and 35th day), posture measurement, diet questionnaire survey and endurance exercise ability test were carried out. The trial period was 35 days. The subjects will take blood samples before, during, after, and 30 minutes and 60 minutes after the end of the two endurance exercise tests. During the whole period of participating in the program, blood will be collected 10 times, each with a blood volume of 15 mL. Gas is collected during the period and within 1 hour after exercise. Gas is collected every 15 minutes and 1 minute at a time. Analyze his exercise time, oxygen intake and blood biochemical value.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 31, 2020
• Est. primary completion date: August 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• The subject is a male and aged 20-40.

• The subject has a usual exercise habit (exercising 2 times or more per week) and did not participate in professional sports competitions or professional sports training during the study period.

• No smoking or drinking habits.

• No food allergies and the liver function is normal.

• No cardiovascular diseases or other chronic diseases, and no serious illnesses requiring hospitalization during the study period.

• The subject can understand the test process described in the consent form and the possible potential risks and benefits, and can sign the consent form.

• The subject can accept dietary control during the trial period.

Exclusion Criteria:

• Those who have taken nutritional supplements containing branched-chain amino acids.

• Those who cannot complete the endurance exercise ability test.

• Those who are diagnosed with kidney disease, heart disease, or cancer and are still under active treatment.

• Have used other drugs, whose pharmacological effects may affect fatigue.

• Subjects who have systemic infections and require systemic antibiotics.

Related Conditions & MeSH terms

• Fatigue
• Healthy

Intervention

Dietary Supplement:
• Okara protein hydrolysate (OPH)
Okara protein hydrolysate (OPH) was a pack of dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung	South

Sponsors (2)

Lead Sponsor	Collaborator
Chung Shan Medical University	National Taichung University of Education

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change the metabolic substances level after intervention	Compare the difference of blood lactate, lactate dehydrogenase, and creatine kinase level after exercise between pre- and post-intervention	8th day, 35th day
Secondary	Change the exercise time after intervention	Compare the exercise time between pre- and post-intervention	8th day, 35th day