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Curcuma Extract Beneficial for Muscle Damage

Primary Purpose

Athletes Foot

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Ice cream
Sponsored by
Universitas Muhammadiyah Semarang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Athletes Foot focused on measuring Curcuma extract, ice cream, inflammation, muscle damage

Eligibility Criteria

14 Years - 18 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Treatment Group

Arm Description

treated by ice cream without any Curcuma extract supplementation

treated by ice cream supplemented by Curcuma extract

Outcomes

Primary Outcome Measures

Lactic acid change
Change from baseline lactic acid at 21 days taken in the lab from venous blood specimen using spectrophotometric method
Hemoglobin change
Change from baseline hemoglobin at 21 days taken in the lab from venous blood specimen using cyanmethemoglobin method
IL-6 change
Change from baseline IL-6 at 21 days taken in the lab from venous blood specimen using ELISA method
Creatinine kinase change
Change from baseline creatinine kinase at 21 days taken in the lab from venous blood specimen using ELISA method

Secondary Outcome Measures

Full Information

First Posted
June 11, 2020
Last Updated
June 18, 2020
Sponsor
Universitas Muhammadiyah Semarang
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1. Study Identification

Unique Protocol Identification Number
NCT04439981
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
July 8, 2019 (Actual)
Study Completion Date
July 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Muhammadiyah Semarang

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletes Foot
Keywords
Curcuma extract, ice cream, inflammation, muscle damage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
treated by ice cream without any Curcuma extract supplementation
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
treated by ice cream supplemented by Curcuma extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Ice cream
Intervention Description
Curcumin extract was added into ice cream
Primary Outcome Measure Information:
Title
Lactic acid change
Description
Change from baseline lactic acid at 21 days taken in the lab from venous blood specimen using spectrophotometric method
Time Frame
21 days
Title
Hemoglobin change
Description
Change from baseline hemoglobin at 21 days taken in the lab from venous blood specimen using cyanmethemoglobin method
Time Frame
21 days
Title
IL-6 change
Description
Change from baseline IL-6 at 21 days taken in the lab from venous blood specimen using ELISA method
Time Frame
21 days
Title
Creatinine kinase change
Description
Change from baseline creatinine kinase at 21 days taken in the lab from venous blood specimen using ELISA method
Time Frame
21 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Rosidi, Doctor
Organizational Affiliation
Universitas Muhammadiyah Semarang
Official's Role
Principal Investigator
Facility Information:
Facility Name
Badan Pusat Pendidikan dan Pelatihan Olahraga Pelajar (BPPLOP) Semarang, Indonesia
City
Semarang
State/Province
Provinsi
ZIP/Postal Code
50198
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

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Curcuma Extract Beneficial for Muscle Damage

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