Efficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2012
CompletedFirst Posted
Study publicly available on registry
September 21, 2012
CompletedStudy Start
First participant enrolled
April 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2014
CompletedAugust 26, 2019
August 1, 2019
1.2 years
September 18, 2012
August 21, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
Changes in lactate
Lactate was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in ammonia
Ammonia was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in inorganic phosphorus
Inorganic phosphorus was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in creatine kinase
Creatine kinase was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Changes in Lactage dehydrogenase(LDH)
Lactage dehydrogenase(LDH) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Secondary Outcomes (2)
Changes in Multidimensional Fatigue Scale(MFS)
12 weeks
Changes in 36-Item Short-Form Health Survey(SF-36)
12 weeks
Study Arms (2)
Fermented Velvet Antler extract
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Fermented Velvet Antler extract (1g/day)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Trial Center for Functional Foods
Study Record Dates
First Submitted
September 18, 2012
First Posted
September 21, 2012
Study Start
April 25, 2013
Primary Completion
June 26, 2014
Study Completion
June 26, 2014
Last Updated
August 26, 2019
Record last verified: 2019-08