The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic Patients

Study Overview
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Brief Summary
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This is a randomized controlled trial that will be conducted on Saudi prediabetic and diabetic adults aged 18 to 70 years. The aim of the study is to investigate the effect of synbiotic consumption on gut microbiome, glycemic control, and other diabetes-related outcomes in patients with prediabetes and diabetes. A total of 160 participants will be recruited from King Fahd Hospital of the University, Eastern Province, Saudi Arabia and randomly assigned to synbiotic group (prediabetic and diabetic, n=40 each group) or control group (prediabetic and diabetic, n=40 each group) for a 6-month trial. A structured questionnaire will be used for data collection from subjects. The questionnaire will include data related to socioeconomic status, health and diet related history. Primary outcomes including gut microbiome sequencing, glycemic control related parameters and secondary outcomes including inflammatory markers, food intolerance and anthropometric measurements will be measured before the study, after 3 months and after 6 months. The findings of the current study will shed light on the significance of synbiotic consumption on glycemic control and other diabetes-related outcomes and their relation to food allergy and autoimmunity.

Official Title
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The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic Patients: A Double Blinded Randomized Control Trial

Conditions
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Dietary Supplements

Intervention / Treatment
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* Dietary Supplement: Synbiotic group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with type 1 diabetes Patients on insulin therapy Patients on antibiotics Pregnant and lactating women Smoking individuals Patients with comorbidities (except for hyperlipidemia and blood pressure) Patients taking immunosuppressants Patients taking probiotics, prebiotics or synbiotics Exclusion Criteria: Patients with prediabetes (HbA1c of 5.7- 6.4% or a fasting plasma glucose of 100 -125 mg/dl) Patients with type 2 diabetes (HbA1c of ≥ 6.5% or a fasting plasma glucose of ≥ 126 mg/dl Male and female patients aged (18-70) years Patients with HbA1c of ≥ 5.7 or a fasting plasma glucose of ≥100 mg/dl BMI ≥ 25

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synbiotic group<br>Intervention group: Will receive synbiotic supplements: one capsule/day. Each capsule contains 20 billion CFU multi-strain probiotics + prebiotics (inulin and oligosaccharides) for a duration of 6 months. | Dietary Supplement: Synbiotic group<br>* Probiotics and prebiotics<br>|
| No Intervention: Placebo group<br>Will receive a placebo. The placebo will be similar to the synbiotic supplements in appearance. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic markers | HbA1c, FBG (through blood samples) | 6 months | 
| Inflammatory markers | IL-1, IL-10, CRP, IFN-γ (through blood samples) | 6 months | 
| Body Composition parameters | Muscle mass, Fat mass (through a body composition analyzer) | 6 months | 
| BMI | Height and weight will be measured to obtain BMI (kg/m2) | 6 months | 
| Waist circumference | in (cm) by a measurement tape | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome sequencing | Will be obtained through stool samples | 6 months |