Wholegrain Cereal Diet and Insulin Sensitivity

Federico II University

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Other: Refined cereal diet; Other: Wholegrain cereal diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00945854

European Community

04022009

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Wholegrain cereal diet

Active Comparator group

Description:

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

Treatment:

Other: Wholegrain cereal diet

Refined cereal diet

Active Comparator group

Description:

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

Treatment:

Other: Refined cereal diet