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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Okara protein hydrolysate (OPH)

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • South
    • Taichung, South, Taiwan, 402
      • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPH group; Participants should eat a pack of OPH once a day for 28 days. The dosage of the OPH is 11.74 g/day.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change the exercise time after intervention	Compare the exercise time between pre- and post-intervention	8th day, 35th day

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Collaborators: National Taichung University of Education

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Actual): August 23, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: CS2-20042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No