Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-03 @ 6:42 PM
Study NCT ID:
NCT04974450
Status:
UNKNOWN
Last Update Posted:
2021-07-23
First Post:
2021-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trigona Honey and Intestinal Microbiota Among Obese People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-14', 'studyFirstSubmitDate': '2021-07-14', 'studyFirstSubmitQcDate': '2021-07-14', 'lastUpdatePostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of intestinal microbiota in stool', 'timeFrame': 'Changes of microbiota level from day 0 to day 60 after intervention', 'description': 'the level of bifidobacteria, clostridium, and lactobacillus (in colony factor unit/grams) in stool measured using polymerase chain reaction'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': 'Changes of body mass index from day 0 to day 60 after intervention', 'description': 'measured by dividing body weight in kilogram per square meter of height'}, {'measure': 'Lipid Profile', 'timeFrame': 'Changes of lipid profile from day 0 to day 60 after intervention', 'description': 'the level of High-Density Lipoprotein, Low-density lipoprotein, total cholesterol and triglyceride in blood plasma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'trigona honey', 'lipid profile', 'microbiota', 'anthropometry'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '31955768', 'type': 'BACKGROUND', '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.'}, {'pmid': '32184894', 'type': 'BACKGROUND', '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.'}, {'pmid': '32782740', 'type': 'BACKGROUND', '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.'}, {'pmid': '30643535', 'type': 'BACKGROUND', '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.'}, {'pmid': '28246535', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Objective :\n\nNutrition 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\n\nDesign 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\n\nHypothesis using superiority trial, trigona honey will\n\n1. improve microbiota (increase lactobacillus and bifidobacteria and reduce clostridium)\n2. Improving lipid profile\n3. lowering body mass index', 'detailedDescription': 'Target population :\n\nThis study will recruit healthy participants with a body mass index of more than 27\n\nallocation : non-random with propensity score matching\n\nArms\n\n1. 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\n2. Active comparator Commercial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%).\n\nIntervention 8 weeks, once daily. This also applied to the control group\n\nOutcome :\n\n1. Microbiota detected using Polymerase Chain Reaction (PCR)\n\n 1. Sample: Stool\n 2. extraction with 70% ethanol primary PCR\n 3. primer (Lactobacillus and bifidobacteria)\n2. Lipid Profile using blood plasma and homogenous assay High-Density Lipoprotein, Low-Density Lipoprotein, Triglyceride, total cholesterol\n3. Anthropometry Body mass index, body composition (fat percentage), waist circumference\n\nSample Size was calculated using the difference of HDL between groups with the following parameters :\n\nEffect size =0.3 Type 1 error = 5% Power of Study = 80% dropout = 20% total participant 336\n\nAnalysis 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Defined as obese with a body mass index of more than 27\n2. Not having a gastrointestinal disease\n3. Not allergic to the honey component\n\nExclusion criteria:\n\n1. Consuming probiotics for a minimum of one month\n2. Consuming antibiotics for a minimum of one month'}, 'identificationModule': {'nctId': 'NCT04974450', 'briefTitle': 'Trigona Honey and Intestinal Microbiota Among Obese People', 'organization': {'class': 'OTHER', 'fullName': 'Hasanuddin University'}, 'officialTitle': 'Effect of Trigona Honey to Intestinal Microbiota, Lipid Profile and Anthropometric Status in Obese Individuals', 'orgStudyIdInfo': {'id': '1007210708'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trigona Honey', 'description': 'The intervention will be given by oral route in a form of liquid of 70-gram trigona honey once daily for 8 weeks', 'interventionNames': ['Dietary Supplement: Trigona honey']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The intervention will be given by oral route in a form of liquid of 70-gram artificial honey once daily for 8 weeks', 'interventionNames': ['Dietary Supplement: control']}], 'interventions': [{'name': 'Trigona honey', 'type': 'DIETARY_SUPPLEMENT', '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', 'armGroupLabels': ['Trigona Honey']}, {'name': 'control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Artificial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%).', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76124', 'city': 'Makassar', 'state': 'South Sulawesi', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Andi S Rahma, MD', 'role': 'CONTACT', 'email': 'andisittirahma@yahoo.co.id', 'phone': '+625242714698'}, {'name': 'Andi S Rahma, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wahidin Sudirohusodo General Hospital', 'geoPoint': {'lat': -5.14861, 'lon': 119.43194}}], 'centralContacts': [{'name': 'Andi S Rahma, MD', 'role': 'CONTACT', 'email': 'andisittirahma@yahoo.co.id', 'phone': '+6285242714698'}], 'overallOfficials': [{'name': 'Andi S Rahma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasanuddin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'de-identified data will be shared accordingly'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasanuddin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Bumi Herman', 'investigatorAffiliation': 'Hasanuddin University'}}}}