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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
67
Two cereals per day and per subject for 4 weeks
Fecal microbiota profile
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
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.
Time frame: Samples taken after 2 weeks of diet normalization period (baseline) and 4 weeks of cereal bars intake when applicable
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.
Time frame: 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.
Time frame: 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.
Time frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable