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

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Okara protein hydrolysate (OPH)
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Chung Shan Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OPH group

Arm Description

Participants should eat a pack of OPH once a day for 28 days. The dosage of the OPH is 11.74 g/day.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change the exercise time after intervention
Compare the exercise time between pre- and post-intervention

Full Information

First Posted
July 27, 2021
Last Updated
August 4, 2021
Sponsor
Chung Shan Medical University
Collaborators
National Taichung University of Education
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1. Study Identification

Unique Protocol Identification Number
NCT05000918
Brief Title
Functional Food Application of Okara Protein Hydrolysate (OPH)- for Anti-exercise-fatigue
Official Title
Functional Food Application of Okara Protein Hydrolysate (OPH)- for Anti-exercise-fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 17, 2020 (Actual)
Primary Completion Date
August 23, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chung Shan Medical University
Collaborators
National Taichung University of Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPH group
Arm Type
Experimental
Arm Description
Participants should eat a pack of OPH once a day for 28 days. The dosage of the OPH is 11.74 g/day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Okara protein hydrolysate (OPH)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change the metabolic substances level after intervention
Description
Compare the difference of blood lactate, lactate dehydrogenase, and creatine kinase level after exercise between pre- and post-intervention
Time Frame
8th day, 35th day
Secondary Outcome Measure Information:
Title
Change the exercise time after intervention
Description
Compare the exercise time between pre- and post-intervention
Time Frame
8th day, 35th day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
State/Province
South
ZIP/Postal Code
402
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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