CClinicalTrials.gg
Status unknownNCT05560048Updated Nov 30, 2022

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

An interventional study of rice protein RP-80N and placebo in Healthy, sponsored by Chung Shan Medical University. Status unknown at 1 site in Taiwan. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-30.

Sponsored by Chung Shan Medical University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy

Browse trials for

03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's planned enrollment of 18 is below the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Chung Shan Medical University is the lead sponsor of 124 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    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.

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

  • Experimental
    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.

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

Interventions

  • Dietary supplementrice 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

  • Dietary supplementplacebo

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

06

What researchers measure

Primary outcomes

  1. Change the exercise performance after intervention compare the exercise

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

    Time frame: 21th day, 63th day

07

Study locations

1 site
  • Chung Shan Medical University
    Taichung, 40246, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05560048
Lead sponsor
Chung Shan Medical University
Collaborators
VEDAN Enterprise Corporation
Responsible party
Chin-Lin Hsu (Professor, Chung Shan Medical University) — Principal investigator
First posted
Sep 29, 2022
Start date
Sep 30, 2022
Primary completion
Dec 15, 2022 (estimated)
Completion
Jan 30, 2023 (estimated)
Last update
Nov 30, 2022

Study contacts

Yu-Jou Chien, PhD student
principal investigator · Chung Shan Medical University
Ching-Fang Yang, MS student
principal investigator · Chung Shan Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion