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NCT Number: NCT00945854

Wholegrain Cereal Diet and Insulin Sensitivity

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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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Clinical and Experimental Medicine, Federico II University

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wholegrain cereal diet

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

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.

Primary outcomes

  1. Insulin Sensitivity (Si)

    Time frame: 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 outcomes

  1. Postprandial Insulin Changes

    Time frame: 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.

  2. Postprandial Plasma Lipid Changes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jul 24, 2009
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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