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

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ClinicalTrials.gov Identifier: NCT01689467
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, 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.

Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Dietary Supplement: Fermented Velvet Antler extract Dietary Supplement: Placebo Not Applicable

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

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)




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

  2. Changes in ammonia [ Time Frame: 12 weeks ]
    Ammonia was measured in study visit 1(0 week) and visit 3(12 week).

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

  4. Changes in creatine kinase [ Time Frame: 12 weeks ]
    Creatine kinase was measured in study visit 1(0 week) and visit 3(12 week).

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



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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689467


Locations
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Korea, Republic of
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

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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
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Fatigue
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases