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Wholegrain Cereal Diet and Insulin Sensitivity

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ClinicalTrials.gov Identifier: NCT00945854
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
rivellese angela, Federico II University

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: Wholegrain cereal diet Other: Refined cereal diet Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Whole Grain Rich Diet on Insulin Sensitivity in Individuals With Metabolic Syndrome
Study Start Date : March 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : December 2010


Arm Intervention/treatment
Active Comparator: Wholegrain cereal diet
Treatment with a diet based on wholegrain cereals and foods with low glycemic index
Other: 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.
Active Comparator: Refined cereal diet
Treatment with a diet based on refined cereals and foods with high glycemic index
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945854


Locations
Italy
Dept. of Clinical and Experimental Medicine, Federico II University
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
Study Chair: Gabriele Riccardi, Prof. Dept. of Clinical and Experimental Medicine, Federico II University

Publications:
Responsible Party: rivellese angela, prof, Federico II University
ClinicalTrials.gov Identifier: NCT00945854     History of Changes
Other Study ID Numbers: 04022009
European Community
First Posted: July 24, 2009    Key Record Dates
Results First Posted: June 26, 2014
Last Update Posted: June 26, 2014
Last Verified: May 2014

Keywords provided by rivellese angela, Federico II University:
wholegrain cereals
glycemic index
metabolic syndrome
insulin sensitivity

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Hypersensitivity
Insulin Resistance
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs