NCT00945854

Wholegrain Cereal Diet and Insulin Sensitivity

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-03-01
• Completion: 2010-12-01
• First posted: 2009-07-24
• Last updated: 2014-06-26
• Results posted: 2014-06-26

Locations

1 site across 1 country: Italy