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

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

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.

Study Overview

• Status: Unknown
• Conditions: Dietary Supplements
• Intervention / Treatment: Dietary supplement: Synbiotic group

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Synbiotic group; Probiotics and prebiotics
No Intervention: Placebo group; Will receive a placebo. The placebo will be similar to the synbiotic supplements in appearance.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Imam Abdulrahman Bin Faisal University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: IRB-2019-03-227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No