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

Chronic Fatigue Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689467
• Other study ID #: KD-FR-FVE
• Status: Completed
• Phase: N/A
• Start date: April 25, 2013
• Est. completion date: June 26, 2014

Study information

• Verified date: August 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 26, 2014
• Est. primary completion date: June 26, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic

Intervention

Dietary Supplement:
• Fermented Velvet Antler extract
Fermented Velvet Antler extract (1g/day)
• Placebo
Placebo (1g/day)

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in lactate	Lactate was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Primary	Changes in ammonia	Ammonia was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Primary	Changes in inorganic phosphorus	Inorganic phosphorus was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Primary	Changes in creatine kinase	Creatine kinase was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Primary	Changes in Lactage dehydrogenase(LDH)	Lactage dehydrogenase(LDH) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Secondary	Changes in Multidimensional Fatigue Scale(MFS)	Multidimensional Fatigue Scale(MFS) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Secondary	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).	12 weeks