Trigona Honey and Intestinal Microbiota Among Obese People

NCT04974450 | Unknown

• 1 other identifier: 1007210708
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.improve microbiota (increase lactobacillus and bifidobacteria and reduce clostridium)
2. 2.Improving lipid profile
3. 3.lowering body mass index

Conditions

Obesity

Keywords

obesity; trigona honey; lipid profile; microbiota; anthropometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Trigona Honey

EXPERIMENTAL

The intervention will be given by oral route in a form of liquid of 70-gram trigona honey once daily for 8 weeks

Dietary Supplement: Trigona honey

Control

ACTIVE COMPARATOR

The intervention will be given by oral route in a form of liquid of 70-gram artificial honey once daily for 8 weeks

Dietary Supplement: control

Interventions

Trigona honey DIETARY_SUPPLEMENT

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

Trigona Honey

control DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Defined as obese with a body mass index of more than 27
• Not having a gastrointestinal disease
• Not allergic to the honey component

You may not qualify if:

• Consuming probiotics for a minimum of one month
• Consuming antibiotics for a minimum of one month

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Wahidin Sudirohusodo General Hospital

Makassar, South Sulawesi, 76124, Indonesia

RECRUITING

Related 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.

  PMID: 31955768 BACKGROUND

• 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.

  PMID: 32184894 BACKGROUND

• 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.

  PMID: 32782740 BACKGROUND

• 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.

  PMID: 30643535 BACKGROUND

• 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.

  PMID: 28246535 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andi S Rahma, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andi S Rahma, MD

CONTACT

+6285242714698; andisittirahma@yahoo.co.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: 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

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: June 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)