RCT Examining Effects of Probiotics in T2DM Individuals

September 30, 2014 updated by: Universiti Kebangsaan Malaysia Medical Centre

A Double-blind, Randomized Placebo-controlled Parallel Group Study of Probiotics as an Adjuvant Therapy for Individuals With Type 2 Diabetes Mellitus

Background: The connection between gut health and diabetes status is increasingly recognized. Gut microbiota composition in diabetic differs from non-diabetic individuals. Interestingly, the level of glucose tolerance was associated with specific microbiota that was rarely found in healthy individuals. Probiotics is one of the functional foods believed to mediate their health promoting activities through modulating the composition of the gut health. Ingestion of probiotics has been shown not only to influence gut microbiota composition but also the secretion of the gut hormones and insulin resistance in animal models with limited trials in human. Supplementation with probiotic has also been shown not only affect glucose homeostasis, but improved other diabetes related comorbidities such as obesity, hypertension, and hyperlipidemia.

Objectives and hypotheses: To address this research gap, this Randomized Controlled Trial (RCT) is proposed to determine the efficacy of probiotic supplementations as adjuvant therapy to improve glucose homeostasis through modulating gut microbiota composition and gut hormones secretion in individuals with type 2 diabetes. We hypothesized that the probiotic supplementations will improve blood glucose control as well as other diabetes related co-morbidities in individuals with type 2 diabetes.

Methodology: This is a double blind randomized parallel group control trial with 3 months probiotic supplementation or placebo. After screening the eligible subjects will be selected. Then, after consent taking, subjects will be randomly assigned to either receive probiotic or supplement for 3 months. Measurements of blood parameters including glycemic control related parameters, lipid profile, renal profile, and liver function tests as well as three day diet recall, and anthropometry measurements will take place at baseline, after 6 weeks and after 12 months.

Expected Outcomes: Probiotic supplementation as an adjuvant therapy would improve glucose homeostasis and gut health as compared to the placebo and eventually will beneficially affect other diabetes related conditions. This study would provide avenue to identify the possibility of probiotic supplementations as an adjuvant therapy in the management of type 2 diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • WP
      • Kuala Lumpur, WP, Malaysia, 56000
        • Recruiting
        • Universiti Kebangsaan Malaysia Medical Center
        • Principal Investigator:
          • Somayyeh Firouzi, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Established type 2 diabetes with at least 6 months diagnosis
  2. Age between 30 and 65 years
  3. Hb A1c of less than 10% and fasting blood glucose less than 15mmol/l
  4. BMI between 18.5-35 kg/ m2
  5. Have not on any probiotics for the last 2 months prior to the recruitment
  6. Ability to comply to the study protocol
  7. They are treated with stabilized dose of medications (either receiving Sulphonylurea or Biguanides or both)

Exclusion Criteria:

  1. Pregnancy and lactating (subjects will be excluded if they getting pregnant during course of study)
  2. Having advanced diabetes complications except for hypertension and hyperlipidemia
  3. Having acute or chronic illness (such as flu, cancer or arthritis rheumatoid) during the study recruitment which may affect carbohydrate metabolism
  4. Language barriers which cannot be overcome via available resources
  5. Currently being treated with any oral anti-diabetes agents other than Sulphonylurea or Biguanides or being treated with insulin
  6. Using any medication such as steroids or antibiotics which might affect viability of gut microorganism at recruitment and during intervention phase.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: probiotic
subjects in this arm will receive probiotic supplementation for 12 weeks.
Dietary supplement: Probiotic
mix probiotic
Other Names:
  • mix probiotic supplementation
Placebo Comparator: placebo
subjects in this arm will receive placebo in identical sachets similar to probiotics which only differs in the codes mentioned on the label of sachets.
Dietary supplement: Placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hb A1c
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
inflammatory markers
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Lipoproteins
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Investigators

  • Principal Investigator: Somayyeh Firouzi, Master, Nutrition and Dietetic department, University Putra Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

December 16, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimate)

December 19, 2012

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 30, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-02-12-1815RU
  • Universiti Putra Malaysia (Other Grant/Funding Number: Universiti Putra Malaysia)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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