HealthyNCT05560048
Anti-exercise-fatigue Effects of Rice Protein RP-80NY in Men
A study testing rice protein RP-80N in people with Healthy, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
The aim of this study is to investigate the anti-exercise-fatigue effects of rice protein RP-80NY in men Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- rice protein RP-80N
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Sep 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- rice protein RP-80N, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rice protein RP-80NDietary supplement
rice protein RP-80NY were dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight
placeboDietary supplement
placebo were dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: rice protein RP-80N; Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the exercise performance after intervention compare the exercise
Duration of exhaustive exercise test (second) between pre- and post-intervention
Measured: 21th day, 63th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start30 Sep 2022
- Primary completion15 Dec 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- VEDAN Enterprise Corporation
- Responsible party
- Principal investigator, Chin-Lin Hsu, Chung Shan Medical University
- Investigators
- Yu-Jou Chien, PhD student, Principal investigator, Chung Shan Medical UniversityChing-Fang Yang, MS student, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560048
- Sponsor's protocol ID
- CS2-22067
- Status last verified
- Nov 2022
- First submitted
- 16 Sep 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-exercise-fatigue Effects of Rice Protein RP-80NY in Men
- ClinicalTrials.gov ID
- NCT05560048
- Acronym / sponsor ID
- CS2-22067
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- VEDAN Enterprise Corporation
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment to placebo | Experimental | Dietary Supplement: rice protein RP-80N, Dietary Supplement: placeboParticipants 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. |
| placebo to treatment | Experimental | Dietary Supplement: rice protein RP-80N, Dietary Supplement: placeboParticipants 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rice protein RP-80Nrice protein RP-80NY were dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight | Dietary supplement | placebo to treatment, treatment to placebo |
| placeboplacebo were dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight | Dietary supplement | placebo to treatment, treatment to placebo |
Primary outcome
Change the exercise performance after intervention compare the exercise
Time frame: 21th day, 63th day
Duration of exhaustive exercise test (second) between pre- and post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Jou Chien, PhD student principal investigator
Chung Shan Medical University
Ching-Fang Yang, MS student principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rice protein RP-80N in people with Healthy, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change the exercise performance after intervention compare the exercise (time frame: 21th day, 63th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.