Wholegrain Cereal Diet and Insulin Sensitivity

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-12-31

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.

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Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wholegrain cereal diet

Treatment with a diet based on wholegrain cereals and foods with low glycemic index

Group Type ACTIVE_COMPARATOR

Wholegrain cereal diet

Intervention Type OTHER

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.

Refined cereal diet

Treatment with a diet based on refined cereals and foods with high glycemic index

Group Type ACTIVE_COMPARATOR

Refined cereal diet

Intervention Type OTHER

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.

Interventions

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Wholegrain cereal diet

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.

Intervention Type OTHER

Refined cereal diet

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.

Intervention Type OTHER

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:

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No