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Completed

NCT Number: NCT05000918

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

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, South, 402, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Okara protein hydrolysate (OPH)

Dietary Supplement

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 outcomes

  1. Change the metabolic substances level after intervention

    Time frame: 8th day, 35th day

    Compare the difference of blood lactate, lactate dehydrogenase, and creatine kinase level after exercise between pre- and post-intervention

Secondary outcomes

  1. Change the exercise time after intervention

    Time frame: 8th day, 35th day

    Compare the exercise time between pre- and post-intervention

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Collaborators

  • National Taichung University of Education

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 11, 2021
Registry last updated
Aug 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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