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NCT Number: NCT04642482

Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in 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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Muhammadiyah University

Makassar, South Sulawesi, 90221, Indonesia

About this study

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:

  • Faecal Sample handling
  • Patient should undergo 8 hours of fasting prior to faecal examination
  • DNA Extraction
  • Lysate preparation and centrifuge faecal sample
  • Mixing lysate with sample
  • Column wash
  • DNA elution
  • DNA storing
  • DNA sequencing and analysis
  • taxonomical analysis
  • Fasting blood glucose
  • Patient should undergo 8 hours of fasting prior to Fasting blood glucose
  • Blood is taken from cubital vein
  • 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

  • Insulin level
  • Centrifuge blood to obtain the serum
  • The monoclonal anti-insulin antibody is given to the serum
  • detection is based on the anti-insulin antibody and insulin complex formation
  • 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

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

Statistical Analysis

  • General Analysis : Intention To Treat (ITT)
  • Propensity Score Matching will be conducted prior to intervention
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Rillus

Placebo

Drug

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

Primary outcomes

  1. 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)

Other outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 24, 2020
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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