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Completed

NCT Number: NCT01689467

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

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.

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Key information

Conditions

Chronic Fatigue Syndrome Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fermented Velvet Antler extract

Dietary Supplement

Fermented Velvet Antler extract (1g/day)

Placebo

Dietary Supplement

Placebo (1g/day)

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 21, 2012
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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