Trigona Honey and Intestinal Microbiota Among Obese People
NCT ID: NCT04974450
Last Updated: 2021-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-06-01
2021-10-01
Brief Summary
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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
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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
The intervention will be given by oral route in a form of liquid of 70-gram artificial honey once daily for 8 weeks
control
Artificial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%).
Interventions
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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%).
Eligibility Criteria
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Inclusion Criteria
2. Not having a gastrointestinal disease
3. Not allergic to the honey component
Exclusion Criteria
2. Consuming antibiotics for a minimum of one month
18 Years
ALL
Yes
Sponsors
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Hasanuddin University
OTHER
Responsible Party
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Bumi Herman
Assistant Lecturer
Principal Investigators
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Andi S Rahma, MD
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Locations
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Wahidin Sudirohusodo General Hospital
Makassar, South Sulawesi, Indonesia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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1007210708
Identifier Type: -
Identifier Source: org_study_id
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