Clinical trial NCT03899454: Garcinia Mangostana L Rind and Solanum Lycopersicum Fructus Trial to Prevent Exercise-induced Oxidative Stress
Official title: Randomized Clinical Trial of the Effect of G. Mangostana L Rind and Solanum Lycopersicum Fructus Extract to Prevent Exercise-induced Oxidative Stress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Exertion; Excess
Oxidative Stress
Keywords: exercise-induced oxidative-stress
Garcinia mangostana L rind
Lead sponsor: Universitas Negeri Semarang
Sponsor class: OTHER
Collaborators: name: Ministry of Research, Technology and Higher Education, Republic of Indonesia
First posted: 2019-04-02
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two arm treatment
Primary purpose: TREATMENT

Brief summary: Treatments are an administration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) and placebo control.

Detailed description: Double-blinded Randomized Clinical Trial

The population of study will involve sedentary men, the student in Universitas Negeri Semarang aged 18-25 years old, targetted populations are 30 subjects consist of 15 treatment group and the rest 15 placebo-control group. Voluntary sampling will be conducted. Information to the candidates delivered directly, leaflets, and social media broadcasting.

Two arm treatment to be given is an administration of a mixture extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) and placebo control.

The administration of extract treatment and placebo will be given for four weeks.

The primary effect that will be observed is the changes in malondialdehyde (MDA) and high-sensitivity Cardiac-Troponin I (hs-cTnI) level after an ergo-cycle exercise test.

The secondary effect of the treatment that will be observed is the baseline and post-treatment parameters of MDA levels.

Eligibility criteria: Inclusion Criteria:

* sedentary lifestyle
* apparently healthy person
* willing to use the smart-phone application for diet and physical activity monitoring

Exclusion Criteria:

* pathological appearance in ECG

Primary outcomes:
measure: Change ergo-cycle exercise test response to MDA level after 4 weeks treatment
timeFrame: 4 weeks
measure: Change ergo-cycle exercise test response to hs-cTnI level after 4 weeks treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline MDA levels after 4 weeks treatment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Universitas Negeri Semarang
state: Jawa Tengah
Study officials:
affiliation: Universitas Negeri Semarang
name: Mahalul Azam
role: PRINCIPAL_INVESTIGATOR
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