Anti-exercise-fatigue Effects of Rice Protein RP-80NY in Men

Healthy Clinical Trial

Official title:

Anti-exercise-fatigue Effects of Rice Protein RP-80NY in Men

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05560048
• Other study ID #: CS2-22067
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: November 2022
• 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 rice protein RP-80NY in men

Description:

Each subject must undergo a maximum oxygen consumption test 1 week before the intervention (day 1), eat the test food for 28 days (day 1 to day 28), following 14 days of wash-out (day 29 to day 42), and undergo second maximum oxygen consumption test (day 43) and another test food intervention (day 43 to day 70). The assays of anthropometric measurement, diet questionnaire survey, grip strength test and fecal collection were carried out before and after the intervention (the 1st ,28th ,43th and 35th day). Each subject has to join the Wingate anaerobic test (day 21 and day 63), and the endurance exercise test (day 28 and day 70) during the intervention. All of the trial period was 70 days, and the blood samples of the subject will be collected at the times of exercise beginning, 15 min after exercise, the end of exercise, 1 hour after rest, 2 hour after rest ,and 3 hour after rest. During the whole period of participating in the program, blood will be collected 14 times, the blood volume of each times is 10 mL. Gas is collected before the period and within 1 hour, 2 hour and 3 hour after exercise (5 minute at a time). After intervention, the exercise time, oxygen intake, blood biochemical value and gut microbiota will be analyzed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: January 30, 2023
• Est. primary completion date: December 15, 2022
• 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 wingate anaerobic test and the endurance exercise 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:
• rice protein RP-80N
rice protein RP-80NY were dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight
• placebo
placebo were 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

Sponsors (2)

Lead Sponsor	Collaborator
Chung Shan Medical University	VEDAN Enterprise Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change the exercise performance after intervention compare the exercise	Duration of exhaustive exercise test (second) between pre- and post-intervention	21th day, 63th day