NCT05000918

Brief Summary

The aim of this study is to investigate the anti-exercise-fatigue effects of okara protein hydrolysate (OPH) in men

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

July 27, 2021

Last Update Submit

August 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Change the exercise time after intervention

    8th day, 35th day

Study Arms (1)

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

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.

OPH group

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, South, 402, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 11, 2021

Study Start

July 17, 2020

Primary Completion

August 23, 2020

Study Completion

October 31, 2020

Last Updated

August 11, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations