Effect of Trigona Honey to Intestinal Microbiota, Lipid Profile and Anthropometric Status in Obese Individuals
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Level of intestinal microbiota in stool
Study Overview
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%).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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
Intervention: Trigona honey (Dietary Supplement)
Control
The intervention will be given by oral route in a form of liquid of 70-gram artificial honey once daily for 8 weeks
Intervention: control (Dietary Supplement)
Outcomes
Primary Outcomes
Level of intestinal microbiota in stool
Time Frame: 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 Outcomes
- Body Mass Index(Changes of body mass index from day 0 to day 60 after intervention)
- Lipid Profile(Changes of lipid profile from day 0 to day 60 after intervention)
Investigators
Bumi Herman
Assistant Lecturer
Hasanuddin University