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

• Sponsor: Chonbuk National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01689467
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 14
• Patients Per Site Per Month: 4.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue Syndrome	Dietary Supplement: Fermented Velvet Antler extract; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Actual Study Start Date: Apr 25, 2013
• Actual Primary Completion Date: Jun 26, 2014
• Actual Study Completion Date: Jun 26, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fermented Velvet Antler extract	Dietary Supplement: Fermented Velvet Antler extract; Fermented Velvet Antler extract (1g/day)
Placebo Comparator: Placebo	Dietary Supplement: Placebo; Placebo (1g/day)

Outcome Measures

Primary Outcome Measures

1. Changes in lactate [12 weeks]

   Lactate was measured in study visit 1(0 week) and visit 3(12 week).

2. Changes in ammonia [12 weeks]

   Ammonia was measured in study visit 1(0 week) and visit 3(12 week).

3. Changes in inorganic phosphorus [12 weeks]

   Inorganic phosphorus was measured in study visit 1(0 week) and visit 3(12 week).

4. Changes in creatine kinase [12 weeks]

   Creatine kinase was measured in study visit 1(0 week) and visit 3(12 week).

5. 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

1. 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).

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do	Korea, Republic of	560-822

Sponsors and Collaborators

• Chonbuk National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
• ClinicalTrials.gov Identifier: NCT01689467
• Other Study ID Numbers: KD-FR-FVE
• First Posted: Sep 21, 2012
• Last Update Posted: Aug 26, 2019
• Last Verified: Aug 1, 2019

• Additional relevant MeSH terms: Fatigue Syndrome, Chronic; Fatigue

Study Results

No Results Posted as of Aug 26, 2019