Curcuma Extract Beneficial for Muscle Damage

• ClinicalTrials.gov Identifier: NCT04439981
• Recruitment Status: Completed
• First Posted: June 19, 2020
• Last Update Posted: June 19, 2020
• Sponsor: Universitas Muhammadiyah Semarang
• Information provided by (Responsible Party): Ali Rosidi, Dr, Universitas Muhammadiyah Semarang

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Athletes Foot	Dietary Supplement: Ice cream	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Beneficial Effect of Curcuma Extract In Muscle Damage (Study in Soccer Athlete): Randomized Clinical Trial
• Actual Study Start Date: April 8, 2019
• Actual Primary Completion Date: July 8, 2019
• Actual Study Completion Date: July 29, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Control Group; treated by ice cream without any Curcuma extract supplementation	Dietary Supplement: Ice cream; Curcumin extract was added into ice cream
Experimental: Treatment Group; treated by ice cream supplemented by Curcuma extract	Dietary Supplement: Ice cream; Curcumin extract was added into ice cream

Outcome Measures

Primary Outcome Measures :

1. 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
2. Hemoglobin change [ Time Frame: 21 days ]
   Change from baseline hemoglobin at 21 days taken in the lab from venous blood specimen using cyanmethemoglobin method
3. 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
4. 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

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Indonesia

Badan Pusat Pendidikan dan Pelatihan Olahraga Pelajar (BPPLOP) Semarang, Indonesia

Semarang, Provinsi, Indonesia, 50198

Sponsors and Collaborators

Universitas Muhammadiyah Semarang

Investigators

• Principal Investigator: Ali Rosidi, Doctor; Universitas Muhammadiyah Semarang

More Information

• Responsible Party: Ali Rosidi, Dr, Dean of Faculty of Nursing and Health, Universitas Muhammadiyah Semarang, Universitas Muhammadiyah Semarang
• ClinicalTrials.gov Identifier: NCT04439981
• Other Study ID Numbers: Curcuma
• First Posted: June 19, 2020
• Last Update Posted: June 19, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ali Rosidi, Dr, Universitas Muhammadiyah Semarang:

Curcuma extract; ice cream; inflammation; muscle damage

Additional relevant MeSH terms:

Tinea Pedis; Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Pruritus; Skin Manifestations