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

Imam Abdulrahman Bin Faisal University

Status and phase: Completed; Phase 3

Conditions: Dietary Supplements

Treatments: Dietary Supplement: Synbiotic group

Study type: Interventional

Funder types: Other

Identifiers

NCT04552002

IRB-2019-03-227

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

Synbiotic group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Synbiotic group

Placebo group

No Intervention group

Description:

Will receive a placebo. The placebo will be similar to the synbiotic supplements in appearance.