Wholegrain Cereal Diet and Insulin Sensitivity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Federico II University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00945854
First received: July 22, 2009
Last updated: July 27, 2009
Last verified: July 2009
  Purpose

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 Intervention
Metabolic Syndrome
Other: Wholegrain cereal diet
Other: Refined cereal diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Whole Grain Rich Diet on Insulin Sensitivity in Individuals With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lipid metabolism,oxidative status,incretin metabolism and inflammatory markers [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2008
Estimated Study Completion Date: December 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Gabriele Riccardi, Department of Clinical and Experimental Medicine Federico II University Naples
ClinicalTrials.gov Identifier: NCT00945854     History of Changes
Other Study ID Numbers: 04022009, European Community
Study First Received: July 22, 2009
Last Updated: July 27, 2009
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014