Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity

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.