NCT04439981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 11, 2020

Last Update Submit

June 18, 2020

Conditions

Keywords

Curcuma extractice creaminflammationmuscle damage

Outcome Measures

Primary Outcomes (4)

  • Lactic acid change

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

    21 days

  • Hemoglobin change

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

    21 days

  • IL-6 change

    Change from baseline IL-6 at 21 days taken in the lab from venous blood specimen using ELISA method

    21 days

  • Creatinine kinase change

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

    21 days

Study Arms (2)

Control Group

PLACEBO COMPARATOR

treated by ice cream without any Curcuma extract supplementation

Dietary Supplement: Ice cream

Treatment Group

EXPERIMENTAL

treated by ice cream supplemented by Curcuma extract

Dietary Supplement: Ice cream

Interventions

Ice creamDIETARY_SUPPLEMENT

Curcumin extract was added into ice cream

Control GroupTreatment Group

Eligibility Criteria

Age14 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • male
  • 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

You may not qualify if:

  • Subject did not comply the procedure of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Semarang, Provinsi, 50198, Indonesia

Location

MeSH Terms

Conditions

Tinea PedisInflammation

Interventions

Ice Cream

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousFoot DermatosesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPruritusSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Dairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ali Rosidi, Doctor

    Universitas Muhammadiyah Semarang

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of Faculty of Nursing and Health, Universitas Muhammadiyah Semarang

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 19, 2020

Study Start

April 8, 2019

Primary Completion

July 8, 2019

Study Completion

July 29, 2019

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations