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

Not Applicable

Completed

• Conditions: Chronic Fatigue Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Fermented Velvet Antler extract

• Registration Number: NCT01689467
• Lead Sponsor: Chonbuk National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-21
• Study Start: 2013-04-25
• Primary Completion: 2014-06-26
• Study Completion: 2014-06-26
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Fermented Velvet Antler extract	Fermented Velvet Antler extract	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of