search
Back to results

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

Primary Purpose

Dietary Supplements

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Synbiotic group
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dietary Supplements

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Synbiotic group

    Placebo group

    Arm Description

    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.

    Will receive a placebo. The placebo will be similar to the synbiotic supplements in appearance.

    Outcomes

    Primary Outcome Measures

    Glycemic markers
    HbA1c, FBG (through blood samples)
    Inflammatory markers
    IL-1, IL-10, CRP, IFN-γ (through blood samples)
    Body Composition parameters
    Muscle mass, Fat mass (through a body composition analyzer)
    BMI
    Height and weight will be measured to obtain BMI (kg/m2)
    Waist circumference
    in (cm) by a measurement tape

    Secondary Outcome Measures

    Microbiome sequencing
    Will be obtained through stool samples

    Full Information

    First Posted
    September 1, 2020
    Last Updated
    September 15, 2020
    Sponsor
    Imam Abdulrahman Bin Faisal University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04552002
    Brief Title
    The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic Patients
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    March 2021 (Anticipated)
    Study Completion Date
    June 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Imam Abdulrahman Bin Faisal University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dietary Supplements

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Synbiotic group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo group
    Arm Type
    No Intervention
    Arm Description
    Will receive a placebo. The placebo will be similar to the synbiotic supplements in appearance.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Synbiotic group
    Intervention Description
    Probiotics and prebiotics
    Primary Outcome Measure Information:
    Title
    Glycemic markers
    Description
    HbA1c, FBG (through blood samples)
    Time Frame
    6 months
    Title
    Inflammatory markers
    Description
    IL-1, IL-10, CRP, IFN-γ (through blood samples)
    Time Frame
    6 months
    Title
    Body Composition parameters
    Description
    Muscle mass, Fat mass (through a body composition analyzer)
    Time Frame
    6 months
    Title
    BMI
    Description
    Height and weight will be measured to obtain BMI (kg/m2)
    Time Frame
    6 months
    Title
    Waist circumference
    Description
    in (cm) by a measurement tape
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Microbiome sequencing
    Description
    Will be obtained through stool samples
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Razan A Algarni, Bachelor
    Phone
    0569444331
    Email
    raaalgarni@iau.edu.sa
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tunny Sebastian, PhD
    Phone
    0556391380
    Email
    tspurayidathil@iau.edu.sa

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs