Chronic Fatigue Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFermented Velvet Antler extract
Fermented Velvet Antler extract (1g/day)
DIETARY_SUPPLEMENTPlacebo
Placebo (1g/day)
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in ammonia | 12 weeks | Ammonia was measured in study visit 1(0 week) and visit 3(12 week). |
| Changes in creatine kinase | 12 weeks | Creatine kinase 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). |
| Changes in lactate | 12 weeks | Lactate 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Countries
South Korea
Outcome results
None listed