Clinical trial NCT04439981: Curcuma Extract Beneficial for Muscle Damage
Official title: Beneficial Effect of Curcuma Extract In Muscle Damage (Study in Soccer Athlete): Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletes Foot
Keywords: Curcuma extract
ice cream
inflammation
muscle damage
Lead sponsor: Universitas Muhammadiyah Semarang
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 20
Sex: MALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects were divided by 2 groups: control group (n=10), treated by ice cream without any Curcuma extract supplementation; and treatment group (n=10), treated by ice cream supplemented by Curcuma extract.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lactic acid change
timeFrame: 21 days
measure: Hemoglobin change
timeFrame: 21 days
measure: IL-6 change
timeFrame: 21 days
measure: Creatinine kinase change
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Badan Pusat Pendidikan dan Pelatihan Olahraga Pelajar (BPPLOP) Semarang, Indonesia
state: Provinsi
Study officials:
affiliation: Universitas Muhammadiyah Semarang
name: Ali Rosidi, Doctor
role: PRINCIPAL_INVESTIGATOR
References: