Efficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise
This study is currently recruiting participants.
Verified September 2012 by Chonbuk National University Hospital
Sponsor:
Chonbuk National University Hospital
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
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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
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 May 22, 2013