SUMMARY OF PROTOCOL

Study title: Effect of Probiotics on Neurobehavioral Function and Body Mass Index (BMI) in Diabetes-Associated Obesity: A Randomized Controlled Trial.

Rationale: Obesity is a complex metabolic disease with multifactorial causation. Gut microbiota has been identified to play a significant role in onset and progression of obesity. The microbial-gut-brain axis is an important pathway in which the gut microbiome plays a role in signaling. Alterations in gut microbiome with probiotics have been shown to alleviate symptoms with obesity and neurobehavioral disorder symptoms.

Aim: To investigate the effect of probiotic administration on neurobehavioral functions and body mass index (BMI) in obese patients with diabetes.

Objectives:

Primary objectives:

   To evaluate the effect of probiotics on neurobehavioral functions in obese diabetics.    

  To examine the influence of probiotics on body mass index (BMI) in obese diabetics.

To assess the effect of probiotics on Brain Derived Neurotrophic Factor (BDNF) levels in obese diabetics. 

Secondary objective: To explore potential correlations between neurobehavioral functions, BMI and BDNF levels in obese diabetics. 

Study type: Prospective Interventional Study

Study design: Randomized Controlled Trial

Time frame: April 2024 to August 2025

Population/participants: Diagnosed Diabetic Obese patients (30-60 years) will be taken from Diabetics, Endocrinology and Metabolism, OPD. The patients will be diagnosed based on American Diabetes Association (ADA) criteria which defines diabetes as blood HbA1c ≥ 6.5% and WHO criteria which defines obesity as Body mass index (BMI) ≥ 30.

Outcome measures:

        Change in DASS Score after 12 weeks

        Change in BMI after 12 weeks

        Change in serum BDNF levels after 12 weeks

Sample size: We have searched the literature extensively and could not find any article directly related to our primary objective, which is the effect of probiotics on neurobehavioral functions in obese diabetics. Due to this paucity of literature, we propose this study as pilot study. Since it is a pilot study, a convenient sample size of 30 subjects is required in each group. The total 60 subjects will be randomized among two groups as per computer generated random number technique i.e. Group A on standard treatment and Group B on standard treatment plus probiotics.

Procedure: All the participants included in this study will undergo complete physical, clinical and anthropometric assessment; prior to participation. After the clinical evaluation is complete, the study participants who fulfill the inclusion criteria and who sign the informed consent will be recruited for the study. Height and weight measurement for BMI calculation will be done and 3ml blood sample will be collected for serum BDNF levels. Participants would be asked to fill in DASS-42 scale to determine the neurobehavioral functions.