Back to resultsEfficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise
Primary Purpose
Chronic Fatigue Syndrome
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fermented Velvet Antler extract
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Fatigue Syndrome
Eligibility Criteria
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.
Sites / Locations
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fermented Velvet Antler extract
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Changes in lactate
Lactate was measured in study visit 1(0 week) and visit 3(12 week).
Changes in ammonia
Ammonia was measured in study visit 1(0 week) and visit 3(12 week).
Changes in inorganic phosphorus
Inorganic phosphorus was measured in study visit 1(0 week) and visit 3(12 week).
Changes in creatine kinase
Creatine kinase was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Lactage dehydrogenase(LDH)
Lactage dehydrogenase(LDH) was measured in study visit 1(0 week) and visit 3(12 week).
Secondary Outcome Measures
Changes in Multidimensional Fatigue Scale(MFS)
Multidimensional Fatigue Scale(MFS) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in 36-Item Short-Form Health Survey(SF-36)
36-Item Short-Form Health Survey(SF-36) was measured in study visit 1(0 week) and visit 3(12 week).
Full Information
NCT ID
NCT01689467
First Posted
September 18, 2012
Last Updated
August 21, 2019
Sponsor
Chonbuk National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01689467
Brief Title
Efficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2013 (Actual)
Primary Completion Date
June 26, 2014 (Actual)
Study Completion Date
June 26, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fermented Velvet Antler extract
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Fermented Velvet Antler extract
Intervention Description
Fermented Velvet Antler extract (1g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (1g/day)
Primary Outcome Measure Information:
Title
Changes in lactate
Description
Lactate was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in ammonia
Description
Ammonia was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in inorganic phosphorus
Description
Inorganic phosphorus was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in creatine kinase
Description
Creatine kinase was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in Lactage dehydrogenase(LDH)
Description
Lactage dehydrogenase(LDH) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in Multidimensional Fatigue Scale(MFS)
Description
Multidimensional Fatigue Scale(MFS) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in 36-Item Short-Form Health Survey(SF-36)
Description
36-Item Short-Form Health Survey(SF-36) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise
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