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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04439981
Other study ID # Curcuma
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 8, 2019
Est. completion date July 29, 2019

Study information

Verified date June 2020
Source Universitas Muhammadiyah Semarang
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Muscle damage and inflammation is a clinical problem caused by the unimpeachable body adaptation of strenuous exercise through increasing free radicals. Antioxidants content in Curcuma is hypothesized to alleviate the free radicals. This study aimed to examine the effect of Curcuma extract in the form of ice cream to improve muscle damage and inflammation of soccer athletes caused by strenuous exercise. This study was experimental study with pre-post control group design. Male soccer athlete (n=20) were divided into treatment group (n=10) and control group (n=10). The treatment group was treated by Curcuma extract ice cream for 21 days. Blood samples of creatine kinase (as muscle damage marker) and IL-6 (as inflammation marker) were quantified.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 29, 2019
Est. primary completion date July 8, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 14 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Ice cream
Curcumin extract was added into ice cream

Locations

Country Name City State
Indonesia Badan Pusat Pendidikan dan Pelatihan Olahraga Pelajar (BPPLOP) Semarang, Indonesia Semarang Provinsi

Sponsors (1)

Lead Sponsor Collaborator
Universitas Muhammadiyah Semarang

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lactic acid change Change from baseline lactic acid at 21 days taken in the lab from venous blood specimen using spectrophotometric method 21 days
Primary Hemoglobin change Change from baseline hemoglobin at 21 days taken in the lab from venous blood specimen using cyanmethemoglobin method 21 days
Primary IL-6 change Change from baseline IL-6 at 21 days taken in the lab from venous blood specimen using ELISA method 21 days
Primary Creatinine kinase change Change from baseline creatinine kinase at 21 days taken in the lab from venous blood specimen using ELISA method 21 days
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