Functional Food Application of Okara Protein Hydrolysate... | NCT05000918

Studies
Functional Food Application of Okara Protein Hydrolysate (OPH)- for Anti-exercise-fatigue

NCT05000918

Sponsor

Chung Shan Medical University

Status

Completed

Last Update Posted

Aug 11, 2021Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Okara protein hydrolysate (OPH)

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2020Actual

Primary Completion Date

Aug 23, 2020Actual

Completion Date

Oct 31, 2020Actual

First Submitted Date

Jul 27, 2021

First Submission Date that Met QC Criteria

Aug 4, 2021

First Posted Date

Aug 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2021

Last Update Posted Date

Aug 11, 2021Actual

Name	Class
National Taichung University of Education	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Dietary Supplement: Okara protein hydrolysate (OPH)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	8th day, 35th day

Secondary Outcomes

Measure	Description	Time Frame
Change the exercise time after intervention	Compare the exercise time between pre- and post-intervention	8th day, 35th day

Other Outcomes

Not provided

Eligibility Module

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 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Chung Shan Medical University		Taichung	South	402	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided