Dietary Supplements
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSynbiotic group
Probiotics and prebiotics
Sponsors
Imam Abdulrahman Bin Faisal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic markers | 6 months | HbA1c, FBG (through blood samples) |
| Inflammatory markers | 6 months | IL-1, IL-10, CRP, IFN-γ (through blood samples) |
| Body Composition parameters | 6 months | Muscle mass, Fat mass (through a body composition analyzer) |
| BMI | 6 months | Height and weight will be measured to obtain BMI (kg/m2) |
| Waist circumference | 6 months | in (cm) by a measurement tape |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome sequencing | 6 months | Will be obtained through stool samples |
Countries
Saudi Arabia
Outcome results
None listed