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

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ClinicalTrials.gov Identifier: NCT04552002
Recruitment Status : Not yet recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Razan Algarni, Imam Abdulrahman Bin Faisal University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dietary Supplements Dietary Supplement: Synbiotic group Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Synbiotic group

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
Probiotics and prebiotics
No Intervention: Placebo group
Will receive a placebo. The placebo will be similar to the synbiotic supplements in appearance.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Microbiome sequencing [ Time Frame: 6 months ]
    Will be obtained through stool samples


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552002


Contacts
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Contact: Razan A Algarni, Bachelor 0569444331 raaalgarni@iau.edu.sa
Contact: Tunny Sebastian, PhD 0556391380 tspurayidathil@iau.edu.sa

Sponsors and Collaborators
Imam Abdulrahman Bin Faisal University
More Information
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Responsible Party: Razan Algarni, Principal investigator, Imam Abdulrahman Bin Faisal University
ClinicalTrials.gov Identifier: NCT04552002    
Other Study ID Numbers: IRB-2019-03-227
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases