Trigona Honey and Intestinal Microbiota Among Obese People

Study Overview
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Brief Summary
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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 improve microbiota (increase lactobacillus and bifidobacteria and reduce clostridium) Improving lipid profile lowering body mass index

Detailed Description
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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 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 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 : Microbiota detected using Polymerase Chain Reaction (PCR) Sample: Stool extraction with 70% ethanol primary PCR primer (Lactobacillus and bifidobacteria) Lipid Profile using blood plasma and homogenous assay High-Density Lipoprotein, Low-Density Lipoprotein, Triglyceride, total cholesterol 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

Official Title
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Effect of Trigona Honey to Intestinal Microbiota, Lipid Profile and Anthropometric Status in Obese Individuals

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Trigona honey
* Dietary Supplement: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Defined as obese with a body mass index of more than 27 Not having a gastrointestinal disease Not allergic to the honey component Exclusion criteria: Consuming probiotics for a minimum of one month Consuming antibiotics for a minimum of one month

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two different groups will be given two different honey. In the intervention group, trigona honey will be administered for 8 weeks whereas the control group will be given artificial honey that has a similar taste and appearance to the intervention group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trigona Honey<br>The intervention will be given by oral route in a form of liquid of 70-gram trigona honey once daily for 8 weeks | Dietary Supplement: Trigona honey<br>* 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<br>|
| Active Comparator: Control<br>The intervention will be given by oral route in a form of liquid of 70-gram artificial honey once daily for 8 weeks | Dietary Supplement: control<br>* Artificial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, trigona honey, lipid profile, microbiota, anthropometry