An interventional study of Wholegrain cereal diet and Refined cereal diet in Metabolic Syndrome, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-06-26.
Sponsored by Federico II University · Not applicable, Interventional, and Treatment
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 329 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 1,459 interventional studies indexed under Metabolic Syndrome.
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Subjects with at least three of the following criteria of metabolic syndrome according to ATPIII-NCEP criteria:
Exclusion Criteria:
Treatment with a diet based on wholegrain cereals and foods with low glycemic index
Other: Wholegrain 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 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.
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.
Insulin Sensitivity (Si)
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
Time frame: 12 weeks
Postprandial Insulin Changes
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.
Time frame: 12 weeks
Postprandial Plasma Lipid Changes
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.
Time frame: 12 weeks
| Milestone | Wholegrain Cereal Diet | Refined Cereal Diet |
|---|---|---|
| Started | 30 | 30 |
| Completed | 28 | 26 |
| Not completed | 2 | 4 |
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
| 104xmin-1/microU/ml | Wholegrain Cereal Diet | Refined Cereal Diet |
|---|---|---|
| Insulin Sensitivity (Si) | 3.03 ± 0.16 | 3.15 ± 0.19 |
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.
| (microU/mlx3hrs) | Wholegrain Cereal Diet | Refined Cereal Diet |
|---|---|---|
| Postprandial Insulin Changes | 50.01 ± 10.2 | 64.4 ± 12.4 |
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.
| mg/dlx3hrs | Wholegrain Cereal Diet | Refined Cereal Diet |
|---|---|---|
| Postprandial Plasma Lipid Changes | 22.7 ± 4.2 | 47.6 ± 6.8 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Wholegrain Cereal Diet | — | 0/30 (0%) | 0/30 (0%) |
| Refined Cereal Diet | — | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Wholegrain Cereal Diet | Refined Cereal Diet | Total |
|---|---|---|---|
| Mean | 57.2 ± 8.5 | 57.4 ± 7.3 | 57.2 ± 7.9 |
| Sex: Female, Male(Participants) | Wholegrain Cereal Diet | Refined Cereal Diet | Total |
|---|---|---|---|
| Female | 17 | 17 | 34 |
| Male | 13 | 13 | 26 |
| Region of Enrollment(participants) | Wholegrain Cereal Diet | Refined Cereal Diet | Total |
|---|---|---|---|
| Italy | 30 | 30 | 60 |
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Federico II University