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

Phase 3

• Conditions: Dietary Supplements
• Interventions: Dietary Supplement: Synbiotic group

• Registration Number: NCT04552002
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-17
• Last Update Posted: 2020-09-17
• Study Start: 2020-10
• Primary Completion: 2021-03
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synbiotic group	Synbiotic group	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Microbiome sequencing	6 months	Will be obtained through stool samples