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

NCT ID: NCT04552002

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-06
• Study Completion Date: 2025-04-20

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.

Conditions

Dietary Supplements

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Synbiotic group

Intervention Type: DIETARY_SUPPLEMENT

Probiotics and prebiotics

Placebo group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Synbiotic group

Probiotics and prebiotics

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role: lead

Responsible Party

Razan Algarni

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Family Medicince Community Centre

Dammam, Eastern Province, Saudi Arabia

King Fahd University Hospital

Dammam, Eastern Province, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

IRB-2019-03-227

Identifier Type: -

Identifier Source: org_study_id