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| Name | Class |
|---|---|
| University Hospital, Geneva | OTHER |
| Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement | OTHER |
| Imperial College London | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lean non diabetic | No Intervention | Lean and healthy subjects receiving no intervention | |
| Overweight non diabetic | Experimental | fiber rich cereal bars, two bars a day for 4 weeks |
|
| Overweight diabetic | Experimental | fiber rich cereal bars, two bars a day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiber rich cereal bars | Other | Two cereals per day and per subject for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiota profile | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Samples taken after 2 weeks of diet normalization period (baseline) and 4 weeks of cereal bars intake when applicable |
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Inclusion Criteria:
-All diabetic and control non-diabetic subjects (of same BMI) must comply with all the following inclusion criteria:
Lean non-diabetic healthy subjects must comply with the following inclusion criteria:
Exclusion Criteria:
Diabetic and healthy (same BMI) subjects representing one or more of the following criteria are excluded from participation in the study.
Lean healthy subjects representing one or more of the following criteria are excluded from participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Alain Golay, Prof | University Hospital, Geneva | Principal Investigator |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. | Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable |
| 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. | Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable |
| 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. | Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable |
| 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. | Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable |
| 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. | Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable |
| 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. | Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable |
| 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. | Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable |
| 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. | Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |