Wholegrain Cereal Diet and Insulin Sensitivity

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Whole Grain Rich Diet on Insulin Sensitivity in Individuals With Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: Wholegrain cereal diet
* Other: Refined cereal diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with at least three of the following criteria of metabolic syndrome according to ATPIII-NCEP criteria: waist circumference >102 for men and 88 for women, fasting total serum triacyglycerol concentration >1.7 mmol/L, fasting HDL cholesterol <1.0 mmol/L for men or <1.3 mmol/L for women, IFG (plasma glucose between 6.1 and 6.9 mmol/L) or 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wholegrain cereal diet<br>Treatment with a diet based on wholegrain cereals and foods with low glycemic index | Other: Wholegrain cereal diet<br>* Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules.<br>|
| Active Comparator: Refined cereal diet<br>Treatment with a diet based on refined cereals and foods with high glycemic index | Other: Refined cereal diet<br>* Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity (Si) | 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Insulin Changes | 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. | 12 weeks | 
| Postprandial Plasma Lipid Changes | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wholegrain cereals, glycemic index, metabolic syndrome, insulin sensitivity