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Completed

NCT Number: NCT04552002

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

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Family Medicince Community Centre, Dammam, Eastern Province, Saudi Arabia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synbiotic group

Dietary Supplement

Probiotics and prebiotics

Primary outcomes

  1. Glycemic markers

    Time frame: 6 months

    HbA1c, FBG (through blood samples)

  2. Inflammatory markers

    Time frame: 6 months

    IL-1, IL-10, CRP, IFN-γ (through blood samples)

  3. Body Composition parameters

    Time frame: 6 months

    Muscle mass, Fat mass (through a body composition analyzer)

  4. BMI

    Time frame: 6 months

    Height and weight will be measured to obtain BMI (kg/m2)

  5. Waist circumference

    Time frame: 6 months

    in (cm) by a measurement tape

Secondary outcomes

  1. Microbiome sequencing

    Time frame: 6 months

    Will be obtained through stool samples

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2020
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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