- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04439981
Curcuma Extract Beneficial for Muscle Damage
Beneficial Effect of Curcuma Extract In Muscle Damage (Study in Soccer Athlete): Randomized Clinical Trial
Study Overview
Detailed Description
Muscle damage is a clinical problem caused by the adaptation process in strenuous exercise of soccer athletes which free radical is the main culprit of the damage. There is a significant increment of muscle damage after strength exercise using leg press. Physical exercise leads to inflammation process in endothelial cells of blood vessel which can be marked by releasing cytokine. Interleukin-6 (IL-6) is one of cytokine pro-inflammation and this marker is used as an indicator for inflammation of micro-trauma in muscle during strenuous exercise.
Normally, free radical generation will be stabilized by endogenous antioxidant secretion such as superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase; nevertheless, body needs exogenous antioxidant to support endogenous antioxidant as a scavenger of free radical in such condition.
Muscle damage due to the strenuous exercise should be managed to avoid the pain feeling and subsequently decrease athlete performances. Some previous studies used herbs such as ginger (Zingiber officinale), ginseng (Panax quinquefolium), and Curcuma to relieve the muscle damage and inflammation resulting from high-intensity exercise.The Curcuma extract treatment to the athlete gained lack of success; therefore, supplementation to food products might use to increase acceptability. Ice cream is one of the products, which has a broad segment market and every single person regardless of age is fond of it.
Curcumin is an antioxidant substance contained in Curcuma and it has better antioxidant capacity compared to the other component in Curcuma such as demetoksicurcumin and bisdemetoksicurcumin.Besides, curcumin has an efficient reaction with superoxide radicals as well as lipid antioxidants has, and the reaction leads to superoxide catalytic degradation in which curcumin represents as a superoxide dismutase. This study aimed to examine the Curcuma extract effect which has been supplemented to own-made ice cream in muscle damage and inflammation of soccer athletes after having strenuous exercise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Provinsi
-
Semarang, Provinsi, Indonesia, 50198
- Badan Pusat Pendidikan dan Pelatihan Olahraga Pelajar (BPPLOP) Semarang, Indonesia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- male
- 14-18 year-old
- does not have an acute and chronic
- hemoglobin level ≥13 g/L
- nutrition status normal (BMI >18.5-25.0)
- no coffee consumption
- no alcohol consumption
- no drugs consumption
- no smoking
- no vitamin and other supplements consumption at least two weeks before this study was conducted
- no additional exercise except the programmed exercise
Exclusion Criteria:
- Subject did not comply the procedure of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
PLACEBO_COMPARATOR: Control Group
treated by ice cream without any Curcuma extract supplementation
|
Curcumin extract was added into ice cream
|
|
EXPERIMENTAL: Treatment Group
treated by ice cream supplemented by Curcuma extract
|
Curcumin extract was added into ice cream
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lactic acid change
Time Frame: 21 days
|
Change from baseline lactic acid at 21 days taken in the lab from venous blood specimen using spectrophotometric method
|
21 days
|
|
Hemoglobin change
Time Frame: 21 days
|
Change from baseline hemoglobin at 21 days taken in the lab from venous blood specimen using cyanmethemoglobin method
|
21 days
|
|
IL-6 change
Time Frame: 21 days
|
Change from baseline IL-6 at 21 days taken in the lab from venous blood specimen using ELISA method
|
21 days
|
|
Creatinine kinase change
Time Frame: 21 days
|
Change from baseline creatinine kinase at 21 days taken in the lab from venous blood specimen using ELISA method
|
21 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ali Rosidi, Doctor, Universitas Muhammadiyah Semarang
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Curcuma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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