Trigona Honey and Intestinal Microbiota Among Obese People

Overview

Objective : Nutrition intervention is one of the approaches to deal with obesity. Natural honey with its polyphenol component has an impact on the intestinal microbiota and lipid profile. Intestinal microbiota such as lactobacillus and bifidobacteria produce exopolysaccharide which plays important roles against obesity. This research aims to assess the effect of Trigona biroi honey on body mass index, lipid profile, and microbiota profile Design A Quasi-experimental study involving two arms (trigona honey) and control will be conducted. The outcome of interests are body mass index, lipid profile, and microbiota profile Hypothesis using superiority trial, trigona honey will 1. improve microbiota (increase lactobacillus and bifidobacteria and reduce clostridium) 2. Improving lipid profile 3. lowering body mass index

Full Title of Study: “Effect of Trigona Honey to Intestinal Microbiota, Lipid Profile and Anthropometric Status in Obese Individuals”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2021

Detailed Description

Target population : This study will recruit healthy participants with a body mass index of more than 27 allocation : non-random with propensity score matching Arms 1. Trigona honey (intervention) composition : vitamin C 0.15%, Protein 1.32%, lipid 0.23%, carbohydrate 64.12%, beta carotene 10.61 ppm, Calcium 273,23, magnesium 338.94, zinc 12.49 ppm, and acidity 5.76. Total polyphenol 133.52 ppm, total flavonoid 159.62 ppm. This liquid has a sour profile 2. Active comparator Commercial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%). Intervention 8 weeks, once daily. This also applied to the control group Outcome : 1. Microbiota detected using Polymerase Chain Reaction (PCR) 1. Sample: Stool 2. extraction with 70% ethanol primary PCR 3. primer (Lactobacillus and bifidobacteria) 2. Lipid Profile using blood plasma and homogenous assay High-Density Lipoprotein, Low-Density Lipoprotein, Triglyceride, total cholesterol 3. Anthropometry Body mass index, body composition (fat percentage), waist circumference Sample Size was calculated using the difference of HDL between groups with the following parameters : Effect size =0.3 Type 1 error = 5% Power of Study = 80% dropout = 20% total participant 336 Analysis Intention to treat will be applied. The descriptive statistic will be used to describe the baseline characteristic of participants. The bivariate analysis will be conducted to see the association of demographic factors to the outcome. If the matching of the participant yields a similar baseline characteristic, the difference of mean between the two groups will be analyzed using an independent t-test. Otherwise, linear mixed model will be applied

Interventions

  • Dietary Supplement: Trigona honey
    • composition : vitamin C 0.15%, Protein 1.32%, lipid 0.23%, carbohydrate 64.12%, beta carotene 10.61 ppm, Calcium 273,23, magnesium 338.94, zinc 12.49 ppm, and acidity 5.76. Total polyphenol 133.52 ppm, total flavonoid 159.62 ppm. This liquid has a sour profile
  • Dietary Supplement: control
    • Artificial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%).

Arms, Groups and Cohorts

  • Experimental: Trigona Honey
    • The intervention will be given by oral route in a form of liquid of 70-gram trigona honey once daily for 8 weeks
  • Active Comparator: Control
    • The intervention will be given by oral route in a form of liquid of 70-gram artificial honey once daily for 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Level of intestinal microbiota in stool
    • Time Frame: Changes of microbiota level from day 0 to day 60 after intervention
    • the level of bifidobacteria, clostridium, and lactobacillus (in colony factor unit/grams) in stool measured using polymerase chain reaction

Secondary Measures

  • Body Mass Index
    • Time Frame: Changes of body mass index from day 0 to day 60 after intervention
    • measured by dividing body weight in kilogram per square meter of height
  • Lipid Profile
    • Time Frame: Changes of lipid profile from day 0 to day 60 after intervention
    • the level of High-Density Lipoprotein, Low-density lipoprotein, total cholesterol and triglyceride in blood plasma

Participating in This Clinical Trial

Inclusion Criteria

1. Defined as obese with a body mass index of more than 27 2. Not having a gastrointestinal disease 3. Not allergic to the honey component Exclusion criteria:

1. Consuming probiotics for a minimum of one month 2. Consuming antibiotics for a minimum of one month

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hasanuddin University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bumi Herman, Assistant Lecturer – Hasanuddin University
  • Overall Official(s)
    • Andi S Rahma, MD, Principal Investigator, Hasanuddin University
  • Overall Contact(s)
    • Andi S Rahma, MD, +6285242714698, andisittirahma@yahoo.co.id

References

de Melo FHC, Menezes FNDD, de Sousa JMB, Dos Santos Lima M, da Silva Campelo Borges G, de Souza EL, Magnani M. Prebiotic activity of monofloral honeys produced by stingless bees in the semi-arid region of Brazilian Northeastern toward Lactobacillus acidophilus LA-05 and Bifidobacterium lactis BB-12. Food Res Int. 2020 Feb;128:108809. doi: 10.1016/j.foodres.2019.108809. Epub 2019 Nov 21.

Jiang L, Xie M, Chen G, Qiao J, Zhang H, Zeng X. Phenolics and Carbohydrates in Buckwheat Honey Regulate the Human Intestinal Microbiota. Evid Based Complement Alternat Med. 2020 Feb 26;2020:6432942. doi: 10.1155/2020/6432942. eCollection 2020.

Lashani E, Davoodabadi A, Soltan Dallal MM. Some probiotic properties of Lactobacillus species isolated from honey and their antimicrobial activity against foodborne pathogens. Vet Res Forum. 2020 Spring;11(2):121-126. doi: 10.30466/vrf.2018.90418.2188. Epub 2020 Jun 15.

Mohd Rafie AZ, Syahir A, Wan Ahmad WAN, Mustafa MZ, Mariatulqabtiah AR. Supplementation of Stingless Bee Honey from Heterotrigona itama Improves Antiobesity Parameters in High-Fat Diet Induced Obese Rat Model. Evid Based Complement Alternat Med. 2018 Nov 21;2018:6371582. doi: 10.1155/2018/6371582. eCollection 2018.

Samat S, Kanyan Enchang F, Nor Hussein F, Wan Ismail WI. Four-Week Consumption of Malaysian Honey Reduces Excess Weight Gain and Improves Obesity-Related Parameters in High Fat Diet Induced Obese Rats. Evid Based Complement Alternat Med. 2017;2017:1342150. doi: 10.1155/2017/1342150. Epub 2017 Jan 26.

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