Curcuma Extract Beneficial for Muscle Damage

Sponsor
Universitas Muhammadiyah Semarang (Other)
Overall Status
Completed
CT.gov ID
NCT04439981
Collaborator
(none)
20
1
2
3.7
5.4

Study Details

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
  • Dietary Supplement: Ice cream
N/A

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
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.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 :
Apr 8, 2019
Actual Primary Completion Date :
Jul 8, 2019
Actual Study Completion Date :
Jul 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 [21 days]

    Change from baseline lactic acid at 21 days taken in the lab from venous blood specimen using spectrophotometric method

  2. Hemoglobin change [21 days]

    Change from baseline hemoglobin at 21 days taken in the lab from venous blood specimen using cyanmethemoglobin method

  3. IL-6 change [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 [21 days]

    Change from baseline creatinine kinase at 21 days taken in the lab from venous blood specimen using ELISA method

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 18 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jun 19, 2020
Last Update Posted:
Jun 19, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
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, Dean of Faculty of Nursing and Health, Universitas Muhammadiyah Semarang, Universitas Muhammadiyah Semarang
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 19, 2020