Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity

November 23, 2020 updated by: Bumi Herman, Hasanuddin University

The Effect of Synbiotic on Intestinal Microbiota and HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) on Obesity

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Location :

This study will recruit the healthy participants from the university

Target Population:

Healthy Participants

General Study Design :

Quasi Experimental study with a comparator

Sample Size calculation :

Difference between two means of HOMA IR from pilot data (7) and standard deviation 2.9, with 5% Type I error, and 80% Power yielded a total of 16 participants for two arms

Management of Sample:

  1. Faecal Sample handling

    1. Patient should undergo 8 hours of fasting prior to faecal examination
    2. DNA Extraction
    3. Lysate preparation and centrifuge faecal sample
    4. Mixing lysate with sample
    5. Column wash
    6. DNA elution
    7. DNA storing
    8. DNA sequencing and analysis
    9. taxonomical analysis

  2. Fasting blood glucose

    1. Patient should undergo 8 hours of fasting prior to Fasting blood glucose
    2. Blood is taken from cubital vein
    3. Spectrometry is conducted based on the NADPH formation from the equation below

    D-glucose+ATP -----> Glucose-6-phospate+ADP Glucose-6-phospate+NAD ---- G-6-PDH ---> D-Gluconate-6 phospate+NADH+H

  3. Insulin level

    1. Centrifuge blood to obtain the serum
    2. The monoclonal anti-insulin antibody is given to the serum
    3. detection is based on the anti-insulin antibody and insulin complex formation
  4. Homeostatic Model Assessment for Insulin Resistance/ HOMA-IR value is calculated from glucose level multiply by insulin level and divided by 405.

Protection for adverse event

  1. All subjects are given the consent regarding the potential harm of synbiotic administration
  2. All subjects will follow the protocol of reporting the any adverse event (most likely, severe constipation)
  3. All subjects will be treated accordingly and hospitalisation if needed.

Statistical Analysis

  1. General Analysis : Intention To Treat (ITT)
  2. Propensity Score Matching will be conducted prior to intervention
  3. A repeated measure ANOVA will be performed, whereas Generalized Linear Mixed Model treating the intervention as dummy variable will be performed if ANOVA assumptions can not be fulfilled.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia, 90221
        • Faculty of Medicine, Muhammadiyah University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age above 18 years old
  2. Not receive antibiotic prescription within the last 6 months

Exclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Synbiotic

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)
Participants in this group will be given a fine powder of synbiotic formula and should be taken orally without diluted with water.
Other Names:
  • Rillus
Active Comparator: Placebo
A powder of 5 gram maltodextrin is given as active comparator, taken orally.
Drug: Placebo
Participants in this group will be given a fine powder of maltodextrin formula and should be taken orally without diluted with water.
Other Names:
  • Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time Frame: Changes of HOMA IR value from baseline to 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abundance-based Coverage Estimator (ACE) Index of Faecal Sample
Time Frame: Prior to intervention (Time 0), 8 weeks after Time 0, and 12 weeks after Time 0
This index defined as the sum of the probabilities of the observed species. The ACE method divides observed frequencies into abundant and rare groups. The abundant species are those with more than 10 individuals in the sample, and the rare species are those with fewer than 10 individuals
Prior to intervention (Time 0), 8 weeks after Time 0, and 12 weeks after Time 0
Shannon Index of Faecal Sample
Time Frame: Prior to intervention (Time 0), 8 weeks after Time 0, and 12 weeks after Time 0
The Shannon diversity index to a value between 0 and 1. Lower values indicate more diversity of microbial gut while higher values indicate less diversity.
Prior to intervention (Time 0), 8 weeks after Time 0, and 12 weeks after Time 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasanuddin University

Investigators

  • Principal Investigator: Andi Anggeraini, Hasanuddin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2019

Primary Completion (Actual)

December 26, 2019

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

November 17, 2020

First Submitted That Met QC Criteria

November 23, 2020

First Posted (Actual)

November 24, 2020

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0711201127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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