HealthyNCT05000918
Functional Food Application of Okara Protein Hydrolysate (OPH)- for Anti-exercise-fatigue
A study testing Okara protein hydrolysate (OPH) 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 okara protein hydrolysate (OPH) 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?
- Okara protein hydrolysate (OPH)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jul 2020to 31 Oct 2020
- 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 endurance exercise ability 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 okara protein hydrolysate (OPH) in men
Read the detailed description
Each subject must undergo a cardiopulmonary capacity test to assess the maximum oxygen uptake 1 week before the intervention (day 1), and then eat the test food for 4 weeks (day 8 to day 35). Before and after the intervention (the 8th and 35th day), posture measurement, diet questionnaire survey and endurance exercise ability test were carried out. The trial period was 35 days. The subjects will take blood samples before, during, after, and 30 minutes and 60 minutes after the end of the two endurance exercise tests. During the whole period of participating in the program, blood will be collected 10 times, each with a blood volume of 15 mL. Gas is collected during the period and within 1 hour after exercise. Gas is collected every 15 minutes and 1 minute at a time. Analyze his exercise time, oxygen intake and blood biochemical value.
- Conditions
- Healthy
- Being tested
- Okara protein hydrolysate (OPH)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Okara protein hydrolysate (OPH)Dietary supplement
Okara protein hydrolysate (OPH) was a pack of dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight.
| Study group | Role | What they receive |
|---|---|---|
| OPH group | Experimental | Participants should eat a pack of OPH once a day for 28 days. The dosage of the OPH is 11.74 g/day. Receives: Dietary Supplement: Okara protein hydrolysate (OPH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the metabolic substances level after intervention
Compare the difference of blood lactate, lactate dehydrogenase, and creatine kinase level after exercise between pre- and post-intervention
Measured: 8th day, 35th day
Secondary outcomes (1)
Change the exercise time after intervention
Compare the exercise time between pre- and post-intervention
Measured: 8th day, 35th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start17 Jul 2020
- Primary completion23 Aug 2020
- Study completion31 Oct 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Taichung University of Education
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000918
- Sponsor's protocol ID
- CS2-20042
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Food Application of Okara Protein Hydrolysate (OPH)- for Anti-exercise-fatigue
- ClinicalTrials.gov ID
- NCT05000918
- Acronym / sponsor ID
- CS2-20042
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- National Taichung University of Education
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 23 Aug 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 11 Aug 2021 (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 okara protein hydrolysate (OPH) in men
Detailed description
Each subject must undergo a cardiopulmonary capacity test to assess the maximum oxygen uptake 1 week before the intervention (day 1), and then eat the test food for 4 weeks (day 8 to day 35). Before and after the intervention (the 8th and 35th day), posture measurement, diet questionnaire survey and endurance exercise ability test were carried out. The trial period was 35 days. The subjects will take blood samples before, during, after, and 30 minutes and 60 minutes after the end of the two endurance exercise tests. During the whole period of participating in the program, blood will be collected 10 times, each with a blood volume of 15 mL. Gas is collected during the period and within 1 hour after exercise. Gas is collected every 15 minutes and 1 minute at a time. Analyze his exercise time, oxygen intake and blood biochemical value.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPH group | Experimental | Dietary Supplement: Okara protein hydrolysate (OPH)Participants should eat a pack of OPH once a day for 28 days. The dosage of the OPH is 11.74 g/day. |
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 endurance exercise ability 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 |
|---|---|---|
| Okara protein hydrolysate (OPH)Okara protein hydrolysate (OPH) was a pack of dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight. | Dietary supplement | OPH group |
Primary outcome
Change the metabolic substances level after intervention
Time frame: 8th day, 35th day
Compare the difference of blood lactate, lactate dehydrogenase, and creatine kinase level after exercise between pre- and post-intervention
1 secondary outcome
Change the exercise time after intervention
Time frame: 8th day, 35th day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Okara protein hydrolysate (OPH) 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: finished, as of the sponsor's last update on 11 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 metabolic substances level after intervention (time frame: 8th day, 35th 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 11 Aug 2021.