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

Dietary Supplements Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04552002
• Other study ID #: IRB-2019-03-227
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 2020
• Est. completion date: June 2021

Study information

• Verified date: September 2020
• Source: Imam Abdulrahman Bin Faisal University
• Contact: Razan A Algarni, Bachelor
• Phone: 0569444331
• Email: raaalgarni[@]iau.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Supplements
• Prediabetic State

Intervention

Dietary Supplement:
• Synbiotic group
Probiotics and prebiotics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic markers	HbA1c, FBG (through blood samples)	6 months
Primary	Inflammatory markers	IL-1, IL-10, CRP, IFN-? (through blood samples)	6 months
Primary	Body Composition parameters	Muscle mass, Fat mass (through a body composition analyzer)	6 months
Primary	BMI	Height and weight will be measured to obtain BMI (kg/m2)	6 months
Primary	Waist circumference	in (cm) by a measurement tape	6 months
Secondary	Microbiome sequencing	Will be obtained through stool samples	6 months