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

NCT04552002 | Completed Phase 3

• 1 other identifier: IRB-2019-03-227
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Microbiome sequencing

  6 months

Study Arms (2)

Synbiotic group

EXPERIMENTAL

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

Placebo group

NO INTERVENTION

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

Interventions

Synbiotic group DIETARY_SUPPLEMENT

Probiotics and prebiotics

Synbiotic group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (2)

Family Medicince Community Centre

Dammam, Eastern Province, Saudi Arabia

Location

King Fahd University Hospital

Dammam, Eastern Province, Saudi Arabia

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 17, 2020
• Study Start: January 6, 2021
• Primary Completion: April 20, 2025
• Study Completion: April 20, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)