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

NCT05560048 | Unknown

• 1 other identifier: CS2-22067
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the anti-exercise-fatigue effects of rice protein RP-80NY in men

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change the exercise performance after intervention compare the exercise

  Duration of exhaustive exercise test (second) between pre- and post-intervention

  21th day, 63th day

Study Arms (2)

treatment to placebo

EXPERIMENTAL

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.

Dietary Supplement: rice protein RP-80N; Dietary Supplement: placebo

placebo to treatment

EXPERIMENTAL

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.

Dietary Supplement: rice protein RP-80N; Dietary Supplement: placebo

Interventions

rice protein RP-80N 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 to treatment; treatment to placebo

placebo 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; treatment to placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead
• VEDAN Enterprise Corporation: collaborator

Study Sites (1)

Chung Shan Medical University

Taichung, 40246, Taiwan

Location

Study Officials

• Yu-Jou Chien, PhD student

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

• Ching-Fang Yang, MS student

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 29, 2022
• Study Start: September 30, 2022
• Primary Completion: December 15, 2022
• Study Completion: January 30, 2023
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

TW (1)