Synbiotic group
Dietary SupplementProbiotics and prebiotics
NCT Number: NCT04552002
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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Notify Me18 year–70 year
All sexes
Interventional
Phase 3
Family Medicince Community Centre, Dammam, Eastern Province, Saudi Arabia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Probiotics and prebiotics
Time frame: 6 months
HbA1c, FBG (through blood samples)
Time frame: 6 months
IL-1, IL-10, CRP, IFN-γ (through blood samples)
Time frame: 6 months
Muscle mass, Fat mass (through a body composition analyzer)
Time frame: 6 months
Height and weight will be measured to obtain BMI (kg/m2)
Time frame: 6 months
in (cm) by a measurement tape
Time frame: 6 months
Will be obtained through stool samples
Imam Abdulrahman Bin Faisal University
Other
The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic Patients: A Double Blinded Randomized Control Trial
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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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