Metabolic Syndrome
Conditions
Keywords
wholegrain cereals, glycemic index, metabolic syndrome, insulin sensitivity
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.
Interventions
OTHERWholegrain 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.
OTHERRefined 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.
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Sensitivity (Si) | 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
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Insulin Changes | 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. |
| Postprandial Plasma Lipid Changes | 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. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wholegrain Cereal Diet Treatment with a diet based on wholegrain cereals and foods with low glycemic index
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. | 30 |
| Refined Cereal Diet Treatment with a diet based on refined cereals and foods with high glycemic index
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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Wholegrain Cereal Diet | Refined Cereal Diet | Total |
|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 8.5 | 57.4 years STANDARD_DEVIATION 7.3 | 57.2 years STANDARD_DEVIATION 7.9 |
| Region of Enrollment Italy | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wholegrain Cereal Diet | Insulin Sensitivity (Si) | 3.03 104xmin-1/microU/ml | Standard Error 0.16 |
| Refined Cereal Diet | Insulin Sensitivity (Si) | 3.15 104xmin-1/microU/ml | Standard Error 0.19 |
p-value: <0.05ANCOVA
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wholegrain Cereal Diet | Postprandial Insulin Changes | 50.01 (microU/mlx3hrs) | Standard Deviation 10.2 |
| Refined Cereal Diet | Postprandial Insulin Changes | 64.4 (microU/mlx3hrs) | Standard Deviation 12.4 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wholegrain Cereal Diet | Postprandial Plasma Lipid Changes | 22.7 mg/dlx3hrs | Standard Deviation 4.2 |
| Refined Cereal Diet | Postprandial Plasma Lipid Changes | 47.6 mg/dlx3hrs | Standard Deviation 6.8 |