Wholegrain Cereal Diet and Insulin Sensitivity

Not Applicable

Completed

Brief Summary: A diet with the multiple beneficial characteristics of whole grains and, more in general, of "healthy cereals" favorably influences glucose and insulin metabolism in subjects with metabolic syndrome. Therefore, the aim of the study is to evaluate the long term effects of a diet containing "healthy cereals" versus a control diet, on glucose and insulin metabolism in subjects with metabolic syndrome.

Recruitment & Eligibility

Inclusion Criteria

Subjects with at least three of the following criteria of metabolic syndrome according to ATPIII-NCEP criteria:
1. waist circumference >102 for men and 88 for women,
2. fasting total serum triacyglycerol concentration >1.7 mmol/L,
3. fasting HDL cholesterol <1.0 mmol/L for men or <1.3 mmol/L for women,
4. IFG (plasma glucose between 6.1 and 6.9 mmol/L) or
5. blood pressure >130/85 mmHg or use of blood pressure medication
Hypertension in stable control (BP <135/80 mmHg) by means of drugs, which will not be allowed to be changed during the study
Absence of main cardiovascular events (IMA, Ictus)

Exclusion Criteria

Diabetes mellitus diagnosed according to history of diabetes or blood glucose ≥ 200 mg/dL (11.1 mmol/L) 2 hours after a 75 g Oral glucose tolerance test (OGTT) to be performed during the run-in period in all the subjects
Any drug able to influence glucose and lipid metabolism (hypolipidemic drugs, cholesterol lowering foodstuffs, anti-inflammatory drugs)
Renal failure (serum creatinine > 1.5 mg/dL) and liver failure (ALT/AST> 2 times above normal values)
Anemia (Hb < 12g/dl) or any other chronic disease

Arm && Interventions

Group	Intervention	Description
Wholegrain cereal diet	Wholegrain cereal diet	Treatment with a diet based on wholegrain cereals and foods with low glycemic index
Refined cereal diet	Refined cereal diet	Treatment with a diet based on refined cereals and foods with high glycemic index

Primary Outcome Measures

Name	Time	Method
Insulin Sensitivity (Si)	12 weeks	Peripheral insulin sensitivity was assessed by FSIGT. A glucose dose of 300 mg/kg body weight was given intravenously followed by a bolus of 0.03 U/kg of insulin injected after 20 min. Blood samples were frequently collected for 3 h for the measurement of plasma glucose and serum insulin concentrations, utilized to calculate the insulin sensitivity index Si

Secondary Outcome Measures

Name	Time	Method
Postprandial Insulin Changes	12 weeks	Blood samples during the standard meal test were drawn from an antecubital vein after a 12 h overnight fast and 0, 30, 60, 90, 120, 150 and 180 min postprandial for the measurement of plasma insulin response reported as average mean postprandial increment.
Postprandial Plasma Lipid Changes	12 weeks	Blood samples during the standard meal test were drawn from an antecubital vein after a 12 h overnight fast and 0, 30, 60, 90, 120, 150 and 180 min postprandial for the measurement of triglyceride response reported as average mean postprandial increment.