Efficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise

August 21, 2019 updated by: Soo-Wan Chae, Chonbuk National University Hospital
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fermented Velvet Antler extract on fatigue recovery after exercise. The investigators measured fatigue recovery parameters , including lactate, ammonia, inorganic phosphorus, creatine kinase and LDH, and monitored their blood pressure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females 19-60 years old
  • Hemoglobin concentration between 13 and 14 g/dL(men), 12 and 13 g/dL(women)
  • Able to give informed consent

Exclusion Criteria:

  • Allergic or hypersensitive to any of the ingredients in the test products
  • History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
  • Participation in any other clinical trials within past 2 months
  • Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
  • Pregnant or lactating women etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo (1g/day)
Experimental: Fermented Velvet Antler extract
Dietary supplement: Fermented Velvet Antler extract
Fermented Velvet Antler extract (1g/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in lactate
Time Frame: 12 weeks
Lactate was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in ammonia
Time Frame: 12 weeks
Ammonia was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in inorganic phosphorus
Time Frame: 12 weeks
Inorganic phosphorus was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in creatine kinase
Time Frame: 12 weeks
Creatine kinase was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in Lactage dehydrogenase(LDH)
Time Frame: 12 weeks
Lactage dehydrogenase(LDH) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Multidimensional Fatigue Scale(MFS)
Time Frame: 12 weeks
Multidimensional Fatigue Scale(MFS) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in 36-Item Short-Form Health Survey(SF-36)
Time Frame: 12 weeks
36-Item Short-Form Health Survey(SF-36) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2013

Primary Completion (Actual)

June 26, 2014

Study Completion (Actual)

June 26, 2014

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

September 18, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Actual)

August 26, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KD-FR-FVE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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