Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity

NCT04642482 | Completed Phase 4

• 1 other identifier: 0711201127
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Background : There is a plausible relationship between microbial gut and insulin resistance. Intervention to prevent insulin resistance by modifying the microbial gut has been proposed but limited studies demonstrates the expected impact. One of the possible way to manipulate the microbial gut is the administration of synbiotic (prebiotic and probiotic). Objective : This study aim to address the impact of synbiotic administration to the microbial gut and insulin resistance. Brief Methodology : A Quasi Experimental study with multiple arms is conducted to healthy participants. All subjects will undergo a microbial gut taxonomic analysis using faecal sample and blood examination to determine the insulin resistance status (using Homeostatic Model Assessment for Insulin Resistance/HOMA-IR approach). Synbiotic will be given to intervention arm and active comparator will use maltodextrin. Repeated measurement will be conducted after 8 weeks and 12 weeks from the day of administration. Hypothesis : A superiority trial hypothesis is applied, assuming that the synbiotic group will demonstrates higher variety of microbial gut and lower HOMA-IR level

Conditions

Obesity; Insulin Resistance

Keywords

Intestinal Microbiota; Probiotic; Insulin Resistance; Obesity

Outcome Measures

Primary Outcomes (1)

• Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  a value representing the insulin resistance yielded by multiplying the blood glucose value and insulin value, then divided by 405 (considering the unit of values are in mg/dL not mmol)

  Changes of HOMA IR value from baseline to 8 weeks

Other Outcomes (2)

• Abundance-based Coverage Estimator (ACE) Index of Faecal Sample

  Prior to intervention (Time 0), 8 weeks after Time 0, and 12 weeks after Time 0

• Shannon Index of Faecal Sample

  Prior to intervention (Time 0), 8 weeks after Time 0, and 12 weeks after Time 0

Study Arms (2)

Synbiotic

EXPERIMENTAL

A fine powder to be taken orally consists of Viable cell 1,0 x 10\^9 Colony Forming Unit of : * Lactobacillus plantarum 8,55 mg * Streptococcus thermophilus 8,55 mg * Bifidobacterium bifidum 2,55 mg * Fructooligosaccharide 480 mg * Additional components : isomalt, xylitol

Dietary Supplement: Synbiotic (Rillus)

Placebo

ACTIVE COMPARATOR

A powder of 5 gram maltodextrin is given as active comparator, taken orally.

Drug: Placebo

Interventions

Synbiotic (Rillus) DIETARY_SUPPLEMENT

Participants in this group will be given a fine powder of synbiotic formula and should be taken orally without diluted with water.

Also known as: Rillus

Synbiotic

Placebo DRUG

Participants in this group will be given a fine powder of maltodextrin formula and should be taken orally without diluted with water.

Also known as: Maltodextrin

Placebo

Eligibility Criteria

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

You may qualify if:

• Age above 18 years old
• Not receive antibiotic prescription within the last 6 months

You may not qualify if:

• Taking medication that alters the blood sugar
• Taking probiotic or synbiotic product (such as yogurt)
• Participant who do not take the synbiotic intervention for more than 3 days consecutively
• incomplete follow up examination results
• Develop adverse effect

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Faculty of Medicine, Muhammadiyah University

Makassar, South Sulawesi, 90221, Indonesia

Location

Related Publications (17)

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  PMID: 20815975 BACKGROUND

• Hagerty SL, Hutchison KE, Lowry CA, Bryan AD. An empirically derived method for measuring human gut microbiome alpha diversity: Demonstrated utility in predicting health-related outcomes among a human clinical sample. PLoS One. 2020 Mar 2;15(3):e0229204. doi: 10.1371/journal.pone.0229204. eCollection 2020.

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• Brahe LK, Astrup A, Larsen LH. Is butyrate the link between diet, intestinal microbiota and obesity-related metabolic diseases? Obes Rev. 2013 Dec;14(12):950-9. doi: 10.1111/obr.12068. Epub 2013 Aug 16.

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• Bermudez-Brito M, Plaza-Diaz J, Munoz-Quezada S, Gomez-Llorente C, Gil A. Probiotic mechanisms of action. Ann Nutr Metab. 2012;61(2):160-74. doi: 10.1159/000342079. Epub 2012 Oct 2.

  PMID: 23037511 BACKGROUND

• Cani PD, Neyrinck AM, Fava F, Knauf C, Burcelin RG, Tuohy KM, Gibson GR, Delzenne NM. Selective increases of bifidobacteria in gut microflora improve high-fat-diet-induced diabetes in mice through a mechanism associated with endotoxaemia. Diabetologia. 2007 Nov;50(11):2374-83. doi: 10.1007/s00125-007-0791-0. Epub 2007 Sep 6.

  PMID: 17823788 BACKGROUND

• Cani PD, Delzenne NM. The role of the gut microbiota in energy metabolism and metabolic disease. Curr Pharm Des. 2009;15(13):1546-58. doi: 10.2174/138161209788168164.

  PMID: 19442172 BACKGROUND

• Chakraborti CK. New-found link between microbiota and obesity. World J Gastrointest Pathophysiol. 2015 Nov 15;6(4):110-9. doi: 10.4291/wjgp.v6.i4.110.

  PMID: 26600968 BACKGROUND

• Le Chatelier E, Nielsen T, Qin J, Prifti E, Hildebrand F, Falony G, Almeida M, Arumugam M, Batto JM, Kennedy S, Leonard P, Li J, Burgdorf K, Grarup N, Jorgensen T, Brandslund I, Nielsen HB, Juncker AS, Bertalan M, Levenez F, Pons N, Rasmussen S, Sunagawa S, Tap J, Tims S, Zoetendal EG, Brunak S, Clement K, Dore J, Kleerebezem M, Kristiansen K, Renault P, Sicheritz-Ponten T, de Vos WM, Zucker JD, Raes J, Hansen T; MetaHIT consortium; Bork P, Wang J, Ehrlich SD, Pedersen O. Richness of human gut microbiome correlates with metabolic markers. Nature. 2013 Aug 29;500(7464):541-6. doi: 10.1038/nature12506.

  PMID: 23985870 BACKGROUND

• Delzenne NM, Neyrinck AM, Cani PD. Gut microbiota and metabolic disorders: How prebiotic can work? Br J Nutr. 2013 Jan;109 Suppl 2:S81-5. doi: 10.1017/S0007114512004047.

  PMID: 23360884 BACKGROUND

• Griffiths EA, Duffy LC, Schanbacher FL, Qiao H, Dryja D, Leavens A, Rossman J, Rich G, Dirienzo D, Ogra PL. In vivo effects of bifidobacteria and lactoferrin on gut endotoxin concentration and mucosal immunity in Balb/c mice. Dig Dis Sci. 2004 Apr;49(4):579-89. doi: 10.1023/b:ddas.0000026302.92898.ae.

  PMID: 15185861 BACKGROUND

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  PMID: 25818484 BACKGROUND

• Kassaian N, Feizi A, Aminorroaya A, Jafari P, Ebrahimi MT, Amini M. The effects of probiotics and synbiotic supplementation on glucose and insulin metabolism in adults with prediabetes: a double-blind randomized clinical trial. Acta Diabetol. 2018 Oct;55(10):1019-1028. doi: 10.1007/s00592-018-1175-2. Epub 2018 Jun 22.

  PMID: 29931423 BACKGROUND

• Kim YA, Keogh JB, Clifton PM. Probiotics, prebiotics, synbiotics and insulin sensitivity. Nutr Res Rev. 2018 Jun;31(1):35-51. doi: 10.1017/S095442241700018X. Epub 2017 Oct 17.

  PMID: 29037268 BACKGROUND

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  PMID: 21812894 BACKGROUND

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  PMID: 20140211 BACKGROUND

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  PMID: 27252163 BACKGROUND

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Synbiotics; maltodextrin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Officials

• Nasrum Massi, Prof.

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Andi Anggeraini

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants receive the synbiotic in the form of fine powder and taken orally and packed with similar packages. Care provider (Research assistants) distribute the unlabeled formulation to the participants. Outcome assessors (laboratory technician) will not be informed regarding the allocation. Investigators are blinded from allocation and will not be informed until the final analysis. Only the statistician will perform and aware of the allocation. A propensity matching score (PSM) is preferred to allocate the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: A multiple-arm study involves three different groups receiving synbiotic (probiotic + prebiotic) and placebo. Observation of intestinal microbiota and insulin resistance is observed in repeated measurement

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 24, 2020
• Study Start: September 24, 2019
• Primary Completion: December 26, 2019
• Study Completion: September 1, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)