Human Faecal Microbiota in Type 2 Diabetes

February 26, 2016 updated by: Société des Produits Nestlé (SPN)

Analysis of the Diversity of Faecal Bacteria in Healthy and Type 2 Diabetic Subjects

The main objective of the clinical trial is to investigate whether overweight type 2 diabetic patients have a different fecal microbiota profile compared with age, gender, BMI matched subjects and with lean healthy subjects before and after the consumption of fiber rich cereal bars.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gut microbiota refers to the bacterial communities in the gastrointestinal tract. The diversity and quantity of bacteria vary depending on age of the individuals, daily diet and the segment of the intestine, which makes the gut microbiota one of the most complex bacterial ecosystems known to men. In general, over trillions of bacteria reside in human gut. Recent evidence indicates that gut microbiota could be involved in host metabolism by multiple pathways leading to the development of obesity and type 2 diabetes. Increased fat storage or obesity has become one of the leading public health issues in many developed and developing countries. However, it is not clear whether type 2 diabetes is associated with a unique gut microbiota profile. Therefore, the primary objective of the study is to compare the fecal microbiota of overweight type 2 diabetic subjects to that of age, gender and BMI matched subjects as well as with lean non-diabetic subjects. In addition, the investigators hypothesize that microbiota modifications with consumption of fiber rich food products can improve the metabolic outcomes of type 2 diabetics. To test this hypothesis, the investigators plan to provide each overweight participant with two cereal bars per day for 4 weeks. Anthropometric measurements and plasma parameters as well as the fecal microbiota will be determined.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

-All diabetic and control non-diabetic subjects (of same BMI) must comply with all the following inclusion criteria:

  • Ethnic background: Caucasian
  • BMI: 25 to 40 kg/m2
  • Fasting blood glucose > 7 mmol/L
  • Fasting Hemoglobin A1c > 7%
  • Consume mainly typical Western diets daily
  • Having obtained his/her informed consent

Lean non-diabetic healthy subjects must comply with the following inclusion criteria:

  • Ethnic background: Caucasian
  • BMI: 20 to 25 kg/m2
  • Fasting blood glucose < 5.5 mmol/L
  • Fasting Hemoglobin A1c < 6 %
  • Consume mainly typical Western diets daily
  • Having obtained his/her informed consent

Exclusion Criteria:

Diabetic and healthy (same BMI) subjects representing one or more of the following criteria are excluded from participation in the study.

  • Dietary supplements or medications known to alter gut bacteria, such as antibiotic medication or intestinal transit modulators
  • People actively take cortisol or dexamethasone should be excluded from the study
  • People under a-amylase/a-glucosidase inhibitors should be excluded from the study. However, patients under metformin can be accepted for this study.
  • Patients under metformin suffering from gastrointestinal side effects within a 6-month time period prior to the trial
  • Regular consumption of fermented dairy products
  • Vegetarians
  • Frequent diarrhea (more than two loose stool per day) within 7 days before the enrollment
  • HIV seropositive
  • Having known gastrointestinal diseases such as ulcerative colitis, Crohn's disease, peptic ulcers and cancer
  • Patients who cannot be expected to comply with treatment
  • Currently participating or having participated in another clinical trial during the last 6 months prior to the beginning of this study
  • Females with hormone therapy will be excluded from the study

Lean healthy subjects representing one or more of the following criteria are excluded from participation in the study.

  • Dietary supplements or medications known to alter gut bacteria, such as antibiotic medication or intestinal transit modulators
  • Regular consumption of fermented dairy products
  • Vegetarians
  • Frequent diarrhea (more than two loose stool per day) within 7 days before the enrollment
  • HIV seropositive
  • Having known gastrointestinal diseases such as ulcerative colitis, Crohn's disease, peptic ulcers and cancer
  • Patients who cannot be expected to comply with treatment
  • Currently participating or having participated in another clinical trial during the last 6 months prior to the beginning of this study
  • Females with hormone therapy will be excluded from the study

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Lean non diabetic
Lean and healthy subjects receiving no intervention
Experimental: Overweight non diabetic
fiber rich cereal bars, two bars a day for 4 weeks
Other: Fiber rich cereal bars
Two cereals per day and per subject for 4 weeks
Other Names:
  • Nutren balance bars
Experimental: Overweight diabetic
fiber rich cereal bars, two bars a day for 4 weeks
Other: Fiber rich cereal bars
Two cereals per day and per subject for 4 weeks
Other Names:
  • Nutren balance bars

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal microbiota profile
Time Frame: Baseline samples taken after 2 weeks of diet normalization period
Fecal samples taken after the two week diet normalization are subjected to bacteria 16S rDNA sequencing and by quantitative PCR.
Baseline samples taken after 2 weeks of diet normalization period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabonomic analysis in faeces
Time Frame: Samples taken after 2 weeks of diet normalization period (baseline) and 4 weeks of cereal bars intake when applicable
Samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects. Then, samples are analyzed by 1HNMR.
Samples taken after 2 weeks of diet normalization period (baseline) and 4 weeks of cereal bars intake when applicable
Metabonomic analysis in plasma
Time Frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects. Then, samples are analyzed by 1HNMR.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Metabonomic analysis in urine
Time Frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects. Then, samples are analyzed by 1HNMR.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma glucose
Time Frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma insulin
Time Frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma free fatty acids
Time Frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma triglycerides
Time Frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma total cholesterol
Time Frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma HDL cholesterol
Time Frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable

Collaborators and Investigators

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

Sponsor

Société des Produits Nestlé (SPN)

Collaborators

University Hospital, Geneva
Imperial College London
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Investigators

  • Principal Investigator: Alain Golay, Prof, University Hospital, Geneva

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

September 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

February 29, 2016

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06.42.NRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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