Trigona Honey and Intestinal Microbiota Among Obese People

Hasanuddin University

Status: Unknown

Conditions: Obesity

Treatments: Dietary Supplement: control; Dietary Supplement: Trigona honey

Study type: Interventional

Funder types: Other

Identifiers

NCT04974450

1007210708

Details and patient eligibility

About

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 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Trigona Honey

Experimental group

Description:

The intervention will be given by oral route in a form of liquid of 70-gram trigona honey once daily for 8 weeks

Treatment:

Dietary Supplement: Trigona honey

Control

Active Comparator group

Description:

The intervention will be given by oral route in a form of liquid of 70-gram artificial honey once daily for 8 weeks

Treatment:

Dietary Supplement: control