Trigona Honey and Intestinal Microbiota Among Obese People
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Trigona honey
control
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, trigona honey, lipid profile, microbiota, anthropometry
Eligibility Criteria
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
Sites / Locations
- Wahidin Sudirohusodo General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Trigona Honey
Control
Arm Description
The intervention will be given by oral route in a form of liquid of 70-gram trigona honey once daily for 8 weeks
The intervention will be given by oral route in a form of liquid of 70-gram artificial honey once daily for 8 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Body Mass Index
measured by dividing body weight in kilogram per square meter of height
Lipid Profile
the level of High-Density Lipoprotein, Low-density lipoprotein, total cholesterol and triglyceride in blood plasma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04974450
Brief Title
Trigona Honey and Intestinal Microbiota Among Obese People
Official Title
Effect of Trigona Honey to Intestinal Microbiota, Lipid Profile and Anthropometric Status in Obese Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasanuddin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
improve microbiota (increase lactobacillus and bifidobacteria and reduce clostridium)
Improving lipid profile
lowering body mass index
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, trigona honey, lipid profile, microbiota, anthropometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Masking in terms of taste and appearance is applied to yield a similar product. Researchers prepare artificial honey formula with citrus flavor to mimic the natural taste of trigona honey. Neither the care provider nor the investigator aware of the allocation.
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trigona Honey
Arm Type
Experimental
Arm Description
The intervention will be given by oral route in a form of liquid of 70-gram trigona honey once daily for 8 weeks
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The intervention will be given by oral route in a form of liquid of 70-gram artificial honey once daily for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Trigona honey
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
control
Intervention Description
Artificial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%).
Primary Outcome Measure Information:
Title
Level of intestinal microbiota in stool
Description
the level of bifidobacteria, clostridium, and lactobacillus (in colony factor unit/grams) in stool measured using polymerase chain reaction
Time Frame
Changes of microbiota level from day 0 to day 60 after intervention
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
measured by dividing body weight in kilogram per square meter of height
Time Frame
Changes of body mass index from day 0 to day 60 after intervention
Title
Lipid Profile
Description
the level of High-Density Lipoprotein, Low-density lipoprotein, total cholesterol and triglyceride in blood plasma
Time Frame
Changes of lipid profile from day 0 to day 60 after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andi S Rahma, MD
Phone
+6285242714698
Email
andisittirahma@yahoo.co.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andi S Rahma, MD
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wahidin Sudirohusodo General Hospital
City
Makassar
State/Province
South Sulawesi
ZIP/Postal Code
76124
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andi S Rahma, MD
Phone
+625242714698
Email
andisittirahma@yahoo.co.id
First Name & Middle Initial & Last Name & Degree
Andi S Rahma, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
de-identified data will be shared accordingly
Citations:
PubMed Identifier
31955768
Citation
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.
Results Reference
background
PubMed Identifier
32184894
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.
Results Reference
background
PubMed Identifier
32782740
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.
Results Reference
background
PubMed Identifier
30643535
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.
Results Reference
background
PubMed Identifier
28246535
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.
Results Reference
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Trigona Honey and Intestinal Microbiota Among Obese People
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