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

Primary Purpose

Healthy

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
rice protein RP-80N
placebo
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 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.

Sites / Locations

  • Chung Shan Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

treatment to placebo

placebo to treatment

Arm Description

Participants should eat rice protein RP-80NY once a day for 28 days, then exchange the treatment sample to placebo after 14 days of wash-out. The dosage of the rice protein RP-80NY or placebo is 0.053 g/kg body weight.

Participants should eat placebo once a day for 28 days, then exchange the treatment sample to rice protein RP-80NY after 14 days of wash-out. The dosage of the rice protein RP-80NY or placebo is 0.053 g/kg body weight.

Outcomes

Primary Outcome Measures

Change the exercise performance after intervention compare the exercise
Duration of exhaustive exercise test (second) between pre- and post-intervention

Secondary Outcome Measures

Full Information

First Posted
September 16, 2022
Last Updated
November 25, 2022
Sponsor
Chung Shan Medical University
Collaborators
VEDAN Enterprise Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05560048
Brief Title
Anti-exercise-fatigue Effects of Rice Protein RP-80NY in Men
Official Title
Anti-exercise-fatigue Effects of Rice Protein RP-80NY in Men
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
Collaborators
VEDAN Enterprise Corporation

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 rice protein RP-80NY in men
Detailed 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.

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
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment to placebo
Arm Type
Experimental
Arm Description
Participants should eat rice protein RP-80NY once a day for 28 days, then exchange the treatment sample to placebo after 14 days of wash-out. The dosage of the rice protein RP-80NY or placebo is 0.053 g/kg body weight.
Arm Title
placebo to treatment
Arm Type
Experimental
Arm Description
Participants should eat placebo once a day for 28 days, then exchange the treatment sample to rice protein RP-80NY after 14 days of wash-out. The dosage of the rice protein RP-80NY or placebo is 0.053 g/kg body weight.
Intervention Type
Dietary Supplement
Intervention Name(s)
rice protein RP-80N
Intervention Description
rice protein RP-80NY were dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
placebo were 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 exercise performance after intervention compare the exercise
Description
Duration of exhaustive exercise test (second) between pre- and post-intervention
Time Frame
21th day, 63th 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Jou Chien, PhD student
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ching-Fang Yang, MS student
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
ZIP/Postal Code
40246
Country
Taiwan

12. IPD Sharing Statement

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

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