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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Chonbuk National University Hospital
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01689467
First received: September 18, 2012
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Chronic Fatigue Syndrome
Dietary Supplement: Fermented Velvet Antler extract
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in lactate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Lactate was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in ammonia [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Ammonia was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in inorganic phosphorus [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Inorganic phosphorus was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in creatine kinase [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Creatine kinase was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in Lactage dehydrogenase(LDH) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    36-Item Short-Form Health Survey(SF-36) was measured in study visit 1(0 week) and visit 3(12 week).


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689467

Contacts
Contact: Dal-Sik Kim, MD., PhD 82-63-250-1793 dskim@chonbuk.ac.kr
Contact: Eun-Ock Park, MS 82-63-250-2539 eopark@jbctc.org

Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Contact: Dal-Sik Kim, MD    82-63-250-1793    dskim@jbnu.ac.kr   
Sponsors and Collaborators
Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01689467     History of Changes
Other Study ID Numbers: KD-FR-FVE
Study First Received: September 18, 2012
Last Updated: September 24, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on July 24, 2014