Human Faecal Microbiota in Type 2 Diabetes

NCT ID: NCT02694172

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-04-30

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.

Conditions

Type 2 Diabetes; Healthy; Overweight

Keywords

diabetes mellitus type 2; healthy subjects; human microbiome; cereal bar

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lean non diabetic

Lean and healthy subjects receiving no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Overweight non diabetic

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

Group Type: EXPERIMENTAL

Fiber rich cereal bars

Intervention Type: OTHER

Two cereals per day and per subject for 4 weeks

Overweight diabetic

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

Group Type: EXPERIMENTAL

Fiber rich cereal bars

Intervention Type: OTHER

Two cereals per day and per subject for 4 weeks

Interventions

Fiber rich cereal bars

Two cereals per day and per subject for 4 weeks

Intervention Type: OTHER

Other Intervention Names

Nutren balance bars

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain Golay, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Other Identifiers

06.42.NRC

Identifier Type: -

Identifier Source: org_study_id