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

Oxidative Stress Clinical Trial

— GMR-RCT-EOS  

Official title:

Randomized Clinical Trial of the Effect of G. Mangostana L Rind and Solanum Lycopersicum Fructus Extract to Prevent Exercise-induced Oxidative Stress

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03899454
• Other study ID #: RCT 201901
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: July 15, 2020
• Est. completion date: September 15, 2022

Study information

• Verified date: July 2019
• Source: Universitas Negeri Semarang
• Contact: Mahalul Azam, MD, PhD
• Phone: +628122853982
• Email: mahalul.azam[@]mail.unnes.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Exertion; Excess
• Oxidative Stress

Intervention

Drug:
• Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract
Administration of mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351)
• Placebo Control
Placebo Control

Locations

Country	Name	City	State
Indonesia	Universitas Negeri Semarang	Semarang	Jawa Tengah

Sponsors (2)

Lead Sponsor	Collaborator
Universitas Negeri Semarang	Ministry of Research, Technology and Higher Education, Republic of Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (8)

Ali Hassan SH, Fry JR, Abu Bakar MF. Phytochemicals content, antioxidant activity and acetylcholinesterase inhibition properties of indigenous Garcinia parvifolia fruit. Biomed Res Int. 2013;2013:138950. doi: 10.1155/2013/138950. Epub 2013 Oct 31. — View Citation

Eijsvogels T, George K, Shave R, Gaze D, Levine BD, Hopman MT, Thijssen DH. Effect of prolonged walking on cardiac troponin levels. Am J Cardiol. 2010 Jan 15;105(2):267-72. doi: 10.1016/j.amjcard.2009.08.679. — View Citation

Knez WL, Jenkins DG, Coombes JS. Oxidative stress in half and full Ironman triathletes. Med Sci Sports Exerc. 2007 Feb;39(2):283-8. — View Citation

Meechai I, Phupong W, Chunglok W, Meepowpan P. Dihydroosajaxanthone: A New Natural Xanthone from the Branches of Garcinia Schomburgkiana Pierre. Iran J Pharm Res. 2018 Fall;17(4):1347-1352. — View Citation

Sutono, T. Efficacy of Garcinia mangostana L. (mangosteen rind extract) to reduce acne severity. Med J Indones. Vol. 22, No. 3, August 2013

Thompson PD, Stern MP, Williams P, Duncan K, Haskell WL, Wood PD. Death during jogging or running. A study of 18 cases. JAMA. 1979 Sep 21;242(12):1265-7. — View Citation

Tjahjani S, Widowati W, Khiong K, Suhendra A, Tjokropranoto R. Antioxidant Properties of Garcinia Mangostana L (Mangosteen) Rind. Procedia Chem. 2014

Tong TK, Kong Z, Lin H, He Y, Lippi G, Shi Q, Zhang H, Nie J. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial. Oxid Med Cell Longev. 2016;2016:4848015. doi: 10.1155/2016/4848015. Epub 2015 Dec 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change ergo-cycle exercise test response to MDA level after 4 weeks treatment	measuring exercise-induced oxidative stress, based on pre-and post-exercise MDA levels	4 weeks
Primary	Change ergo-cycle exercise test response to hs-cTnI level after 4 weeks treatment	measuring exercise-induced oxidative stress, based on pre-and post-exercise hs-cTnI levels	4 weeks
Secondary	Change from baseline MDA levels after 4 weeks treatment	measuring MDA levels baseline and post-treatment	4 weeks