Garcinia Mangostana L Rind and Solanum Lycopersicum Fructus Trial to Prevent Exercise-induced Oxidative Stress

Phase 2

• Conditions: Oxidative Stress; Exertion; Excess
• Interventions: Drug: Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract; Drug: Placebo Control

• Registration Number: NCT03899454
• Lead Sponsor: Universitas Negeri Semarang

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.

Study Timeline

• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-07-30
• Study Start: 2020-07-15
• Primary Completion: 2020-09-15
• Study Completion: 2022-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extract administration	Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract	administration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351)
Control	Placebo Control	Placebo

Primary Outcome Measures

Name	Time	Method
Change ergo-cycle exercise test response to MDA level after 4 weeks treatment	4 weeks	measuring exercise-induced oxidative stress, based on pre-and post-exercise MDA levels
Change ergo-cycle exercise test response to hs-cTnI level after 4 weeks treatment	4 weeks	measuring exercise-induced oxidative stress, based on pre-and post-exercise hs-cTnI levels

Secondary Outcome Measures

Name	Time	Method
Change from baseline MDA levels after 4 weeks treatment	4 weeks	measuring MDA levels baseline and post-treatment

Trial Locations

Locations (1)

Universitas Negeri Semarang; 🇮🇩 Semarang, Jawa Tengah, Indonesia