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

NCT ID: NCT05560048

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-01-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

treatment to placebo

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.

Group Type: EXPERIMENTAL

rice protein RP-80N

Intervention Type: DIETARY_SUPPLEMENT

rice protein RP-80NY were dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight

placebo

Intervention Type: DIETARY_SUPPLEMENT

placebo were dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight

placebo to treatment

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.

Group Type: EXPERIMENTAL

rice protein RP-80N

Intervention Type: DIETARY_SUPPLEMENT

rice protein RP-80NY were dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight

placebo

Intervention Type: DIETARY_SUPPLEMENT

placebo were dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

placebo

placebo were dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

VEDAN Enterprise Corporation

UNKNOWN

Sponsor Role: collaborator

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chin-Lin Hsu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu-Jou Chien, PhD student

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Ching-Fang Yang, MS student

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

Chung Shan Medical University

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CS2-22067

Identifier Type: -

Identifier Source: org_study_id