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

NCT04827628 | Unknown

• 1 other identifier: 1803211718
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lipopolysaccharide; Zonula Occludens 1; Obesity; Oryza sativa; Anthocyanin; Intestinal Microbiota

Outcome Measures

Primary Outcomes (2)

• Lipopolysaccharide (LPS) level of Serum

  Measured using Enzyme-Linked Immunosorbent Assay (ELISA)

  Changes of LPS value from baseline to the last day of intervention (three weeks)

• Microbiota Level in Stool sample

  Measured using primary PCR of total microbiota, Firmicutes-Lactobacillus, Bacteroidetes-Bacteroides fragilis, Actinobacteria-Bifidobacterium and Proteobacteria-E.Coli

  Changes of Microbiota value from baseline to the last day of intervention (three weeks)

Secondary Outcomes (1)

• Zonula Occludens 1 (ZO1) serum level

  Changes of ZO1 value from baseline to the last day of intervention (three weeks)

Study Arms (3)

Obese with Oryza sativa extract

EXPERIMENTAL

The group with a body mass index of more than 25 kg/m2 that receive the Oryza Sativa Extract

Dietary Supplement: Oryza Sativa Extract

Obese with control

ACTIVE COMPARATOR

The group with a body mass index of more than 25 kg/m2 that receive the citric acid and sorbitol mixture

Dietary Supplement: Control

Normal Body Mass Index

ACTIVE COMPARATOR

The group with a body mass index of less than 25 kg/m2 that receive the citric acid and sorbitol mixture

Dietary Supplement: Control

Interventions

Oryza Sativa Extract DIETARY_SUPPLEMENT

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.

Obese with Oryza sativa extract

Control DIETARY_SUPPLEMENT

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

Normal Body Mass Index; Obese with control

Eligibility Criteria

• Age: 18 Years - 21 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• No consumption of the antioxidant supplement
• No consumption of prebiotic and probiotic
• Currently not undergo specific diet

You may not qualify if:

• Current smoker
• Diagnosed with chronic diseases
• Patients with altered kidney and liver function
• Unable to participate for any reason

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Hasanuddin University Medical Research Center / HUMRC

Makassar, South Sulawesi, 90245, Indonesia

Location

Related Publications (11)

• Aguirre M, Venema K. Does the Gut Microbiota Contribute to Obesity? Going beyond the Gut Feeling. Microorganisms. 2015 Apr 27;3(2):213-35. doi: 10.3390/microorganisms3020213.

  PMID: 27682087 BACKGROUND

• Angelakis E, Armougom F, Million M, Raoult D. The relationship between gut microbiota and weight gain in humans. Future Microbiol. 2012 Jan;7(1):91-109. doi: 10.2217/fmb.11.142.

  PMID: 22191449 BACKGROUND

• Tehrani AB, Nezami BG, Gewirtz A, Srinivasan S. Obesity and its associated disease: a role for microbiota? Neurogastroenterol Motil. 2012 Apr;24(4):305-11. doi: 10.1111/j.1365-2982.2012.01895.x. Epub 2012 Feb 20.

  PMID: 22339979 BACKGROUND

• Tan J, Li Y, Hou DX, Wu S. The Effects and Mechanisms of Cyanidin-3-Glucoside and Its Phenolic Metabolites in Maintaining Intestinal Integrity. Antioxidants (Basel). 2019 Oct 12;8(10):479. doi: 10.3390/antiox8100479.

  PMID: 31614770 BACKGROUND

• Morais CA, de Rosso VV, Estadella D, Pisani LP. Anthocyanins as inflammatory modulators and the role of the gut microbiota. J Nutr Biochem. 2016 Jul;33:1-7. doi: 10.1016/j.jnutbio.2015.11.008. Epub 2015 Nov 26.

  PMID: 27260462 BACKGROUND

• Min SW, Ryu SN, Kim DH. Anti-inflammatory effects of black rice, cyanidin-3-O-beta-D-glycoside, and its metabolites, cyanidin and protocatechuic acid. Int Immunopharmacol. 2010 Aug;10(8):959-66. doi: 10.1016/j.intimp.2010.05.009.

  PMID: 20669401 BACKGROUND

• Lee B, Moon KM, Kim CY. Tight Junction in the Intestinal Epithelium: Its Association with Diseases and Regulation by Phytochemicals. J Immunol Res. 2018 Dec 16;2018:2645465. doi: 10.1155/2018/2645465. eCollection 2018.

  PMID: 30648119 BACKGROUND

• Ito VC, Lacerda LG. Black rice (Oryza sativa L.): A review of its historical aspects, chemical composition, nutritional and functional properties, and applications and processing technologies. Food Chem. 2019 Dec 15;301:125304. doi: 10.1016/j.foodchem.2019.125304. Epub 2019 Jul 31.

  PMID: 31394335 BACKGROUND

• Igwe EO, Charlton KE, Probst YC, Kent K, Netzel ME. A systematic literature review of the effect of anthocyanins on gut microbiota populations. J Hum Nutr Diet. 2019 Feb;32(1):53-62. doi: 10.1111/jhn.12582. Epub 2018 Jul 8.

  PMID: 29984532 BACKGROUND

• Hersoug LG, Moller P, Loft S. Gut microbiota-derived lipopolysaccharide uptake and trafficking to adipose tissue: implications for inflammation and obesity. Obes Rev. 2016 Apr;17(4):297-312. doi: 10.1111/obr.12370. Epub 2015 Dec 29.

  PMID: 26712364 BACKGROUND

• Bae IY, An JS, Oh IK, Lee HG. Optimized preparation of anthocyanin-rich extract from black rice and its effects on in vitro digestibility. Food Sci Biotechnol. 2017 Aug 28;26(5):1415-1422. doi: 10.1007/s10068-017-0188-x. eCollection 2017.

  PMID: 30263677 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Agussalim Bukhari, Ph.D

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Nurpudji Taslim, Prof.

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Aminuddin Aminuddin, Ph.D

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Armanto Makmun, M.Kes

  Universitas Muslim Indonesia

  PRINCIPAL INVESTIGATOR

• Rachmat Syamsu, M.Kes

  Universitas Muslim Indonesia

  PRINCIPAL INVESTIGATOR

• Bumi Herman, MD. Ph.D

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bumi Herman, Ph.D

CONTACT

+66638275008; bumiherman@med.unhas.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: a non-randomized trial is implemented involving three arms consists of an obese group as the intervention and two control groups, people with normal Body Mass Index, and Obese.

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: April 10, 2021
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)