Trigona Honey and Intestinal Microbiota Among Obese People

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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Trigona honey; Dietary supplement: control

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andi S Rahma, MD; Phone Number: +6285242714698; Email: andisittirahma@yahoo.co.id

Study Locations

• Indonesia
  • South Sulawesi
    • Makassar, South Sulawesi, Indonesia, 76124
      • Recruiting
      • Wahidin Sudirohusodo General Hospital
      • Contact: Andi S Rahma, MD; Phone Number: +625242714698; Email: andisittirahma@yahoo.co.id
      • Principal Investigator: Andi S Rahma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
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	Dietary supplement: control; Artificial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hasanuddin University
• Investigators: Principal Investigator: Andi S Rahma, MD, Hasanuddin University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (ACTUAL): July 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: obesity; microbiota; lipid profile; anthropometry; trigona honey
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 1007210708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: de-identified data will be shared accordingly

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No