Obesity
Conditions
Keywords
obesity, trigona honey, lipid profile, microbiota, anthropometry
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 1. improve microbiota (increase lactobacillus and bifidobacteria and reduce clostridium) 2. Improving lipid profile 3. 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 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
Interventions
DIETARY_SUPPLEMENTTrigona 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
DIETARY_SUPPLEMENTcontrol
Artificial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%).
Sponsors
Hasanuddin University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of intestinal microbiota in stool | Changes of microbiota level from day 0 to day 60 after intervention | the level of bifidobacteria, clostridium, and lactobacillus (in colony factor unit/grams) in stool measured using polymerase chain reaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Changes of body mass index from day 0 to day 60 after intervention | measured by dividing body weight in kilogram per square meter of height |
| Lipid Profile | Changes of lipid profile from day 0 to day 60 after intervention | the level of High-Density Lipoprotein, Low-density lipoprotein, total cholesterol and triglyceride in blood plasma |
Countries
Indonesia
Contacts
Primary ContactAndi S Rahma, MD
Outcome results
None listed