Effect of Oryza Sativa l Extract to Serum Lipopolysaccharide, Tight Junction Protein 1 (ZO-1), and Intestinal Microbiota Expression Among Obese Individual
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Lipopolysaccharide (LPS) level of Serum
研究概览
简要总结
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.
详细描述
Method:
- Non Randomized clinical trial with double-blind
- Participants will be recruited consecutively
- Matching technique will be applied following several variables adjustment
- Two-arm of the group participants are the normal group, the obese control group, and the obese intervention group
Sample size calculation:
The difference between two independent means sample size calculation is applied following the elements below:
a. Type 1 error: 10% b. Power: 80% c. Effect Size: 0.9 (based on changes of LPS value) d. Dropout rate: 20% e. Hypothesis: Superiority Trial g. The number of participants per group: 14
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
To blind the participant, the mixture is given in the darker bottle, and placebo is given the artificial taste similar to the intervention group. This adjustment also blinds the care provider. The outcome assessor is blinded from the allocation of the group.
入排标准
- 年龄范围
- 18 Years 至 21 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No consumption of the antioxidant supplement
- •No consumption of prebiotic and probiotic
- •Currently not undergo specific diet
排除标准
- •Current smoker
- •Diagnosed with chronic diseases
- •Patients with altered kidney and liver function
- •Unable to participate for any reason
结局指标
主要结局
Lipopolysaccharide (LPS) level of Serum
时间窗: Changes of LPS value from baseline to the last day of intervention (three weeks)
Measured using Enzyme-Linked Immunosorbent Assay (ELISA)
Microbiota Level in Stool sample
时间窗: Changes of Microbiota value from baseline to the last day of intervention (three weeks)
Measured using primary PCR of total microbiota, Firmicutes-Lactobacillus, Bacteroidetes-Bacteroides fragilis, Actinobacteria-Bifidobacterium and Proteobacteria-E.Coli
次要结局
- Zonula Occludens 1 (ZO1) serum level(Changes of ZO1 value from baseline to the last day of intervention (three weeks))
研究者
Bumi Herman
Assistant Lecturer
Hasanuddin University