Effect of Oryza Sativa l Extract to LPS, ZO-1, and Intestinal Microbiota in Obese Individuals

Summary

Background :

Obesity prevalence rises among adults and leads to morbidity and mortality due to subsequent inflammation pathway activation. This activation is induced by higher lipid consumption which activates the Nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) pathway and alters the microbiota profile. The Oryza sativa extract contains anthocyanin which possibly affects the microbiota composition and NF-kb pathway which eventually preserves the protective layer and tight junction of the epithelial cells. Therefore it is important to address the impact of this extract on these parameters.

Objective :

To assess the effect of Oryza sativa extract on microbiota profile (Lactobacillus, Firmicutes, Bacteroides, Bifidobacteria, and Escherichia coli), Lipopolysaccharide/ LPS, and the tight epithelial junction (Zonula Occludens-1) among obese adults.

Method:

A two-arm Quasi-Experimental will be conducted, followed by two repeated measurements, at the baseline and 3 weeks after intervention

Hypothesis:

Oryza sativa extract lowers the LPS level, Firmicutes sp, Bacteroides sp, and increases ZO1 protein, Bifidobacteria, and Lactobacillus sp.

Conditions

• Obesity

Interventions

DIETARY_SUPPLEMENT

Oryza Sativa Extract

The product is a suspension of 5.6 gram/100 mL given once daily, contains 71.9%, purple in color, range pH 3-5. Stored in the darker bottle. The frequency of administration is once-daily after the meal.

DIETARY_SUPPLEMENT

Control

citric acid 0.1g/oz and 1% sorbitol mixture, given once daily after meal

Sponsors & Collaborators

• Hasanuddin University

  lead OTHER

Principal Investigators

• Agussalim Bukhari, Ph.D · Hasanuddin University

• Nurpudji Taslim, Prof. · Hasanuddin University

• Aminuddin Aminuddin, Ph.D · Hasanuddin University

• Armanto Makmun, M.Kes · Universitas Muslim Indonesia

• Rachmat Syamsu, M.Kes · Universitas Muslim Indonesia

• Bumi Herman, MD. Ph.D · Chulalongkorn University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

21 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-10

Primary Completion

2021-05-01

Completion

2021-06-01

Countries

• Indonesia

Study Locations