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Human Faecal Microbiota in Type 2 Diabetes

Primary Purpose

Type 2 Diabetes, Healthy, Overweight

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fiber rich cereal bars
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring diabetes mellitus type 2, healthy subjects, human microbiome, cereal bar

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Lean non diabetic

    Overweight non diabetic

    Overweight diabetic

    Arm Description

    Lean and healthy subjects receiving no intervention

    fiber rich cereal bars, two bars a day for 4 weeks

    fiber rich cereal bars, two bars a day for 4 weeks

    Outcomes

    Primary Outcome Measures

    Fecal microbiota profile
    Fecal samples taken after the two week diet normalization are subjected to bacteria 16S rDNA sequencing and by quantitative PCR.

    Secondary Outcome Measures

    Metabonomic analysis in faeces
    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.
    Metabonomic analysis in plasma
    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.
    Metabonomic analysis in urine
    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.
    Plasma glucose
    Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
    Plasma insulin
    Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
    Plasma free fatty acids
    Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
    Plasma triglycerides
    Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
    Plasma total cholesterol
    Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
    Plasma HDL cholesterol
    Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.

    Full Information

    First Posted
    February 18, 2016
    Last Updated
    February 26, 2016
    Sponsor
    Société des Produits Nestlé (SPN)
    Collaborators
    University Hospital, Geneva, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Imperial College London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02694172
    Brief Title
    Human Faecal Microbiota in Type 2 Diabetes
    Official Title
    Analysis of the Diversity of Faecal Bacteria in Healthy and Type 2 Diabetic Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2007 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Société des Produits Nestlé (SPN)
    Collaborators
    University Hospital, Geneva, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Imperial College London

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes, Healthy, Overweight
    Keywords
    diabetes mellitus type 2, healthy subjects, human microbiome, cereal bar

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lean non diabetic
    Arm Type
    No Intervention
    Arm Description
    Lean and healthy subjects receiving no intervention
    Arm Title
    Overweight non diabetic
    Arm Type
    Experimental
    Arm Description
    fiber rich cereal bars, two bars a day for 4 weeks
    Arm Title
    Overweight diabetic
    Arm Type
    Experimental
    Arm Description
    fiber rich cereal bars, two bars a day for 4 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Fiber rich cereal bars
    Other Intervention Name(s)
    Nutren balance bars
    Intervention Description
    Two cereals per day and per subject for 4 weeks
    Primary Outcome Measure Information:
    Title
    Fecal microbiota profile
    Description
    Fecal samples taken after the two week diet normalization are subjected to bacteria 16S rDNA sequencing and by quantitative PCR.
    Time Frame
    Baseline samples taken after 2 weeks of diet normalization period
    Secondary Outcome Measure Information:
    Title
    Metabonomic analysis in faeces
    Description
    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.
    Time Frame
    Samples taken after 2 weeks of diet normalization period (baseline) and 4 weeks of cereal bars intake when applicable
    Title
    Metabonomic analysis in plasma
    Description
    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.
    Time Frame
    Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
    Title
    Metabonomic analysis in urine
    Description
    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.
    Time Frame
    Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
    Title
    Plasma glucose
    Description
    Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
    Time Frame
    Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
    Title
    Plasma insulin
    Description
    Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
    Time Frame
    Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
    Title
    Plasma free fatty acids
    Description
    Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
    Time Frame
    Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
    Title
    Plasma triglycerides
    Description
    Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
    Time Frame
    Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
    Title
    Plasma total cholesterol
    Description
    Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
    Time Frame
    Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
    Title
    Plasma HDL cholesterol
    Description
    Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
    Time Frame
    Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alain Golay, Prof
    Organizational Affiliation
    University Hospital, Geneva
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Human Faecal Microbiota in Type 2 Diabetes

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