Trigona Honey and Intestinal Microbiota Among Obese People

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04974450
• Other study ID #: 1007210708
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: July 2021
• Source: Hasanuddin University
• Contact: Andi S Rahma, MD
• Phone: +6285242714698
• Email: andisittirahma[@]yahoo.co.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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
• control
Artificial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%).

Locations

Country	Name	City	State
Indonesia	Wahidin Sudirohusodo General Hospital	Makassar	South Sulawesi

Sponsors (1)

Lead Sponsor	Collaborator
Hasanuddin University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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