N/A
Completed N=60
Wholegrain Cereal Diet and Insulin Sensitivity
Source: ClinicalTrials.gov NCT00945854 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Insulin Sensitivity (Si) — 3.03; 3.15 104xmin-1/microU/ml — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Sensitivity (Si) |
3.03; 3.15 | <0.05 sig |
| SECONDARY Postprandial Insulin Changes |
50.01; 64.4 | — |
| SECONDARY Postprandial Plasma Lipid Changes |
22.7; 47.6 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with at least three of the following criteria of metabolic syndrome according to ATPIII-NCEP criteria:
- waist circumference >102 for men and 88 for women,
- fasting total serum triacyglycerol concentration >1.7 mmol/L,
- fasting HDL cholesterol 130/85 mmHg or use of blood pressure medication
- Hypertension in stable control (BP 1.5 mg/dL) and liver failure (ALT/AST> 2 times above normal values)
- Anemia (Hb < 12g/dl) or any other chronic disease
Data sourced from ClinicalTrials.gov (NCT00945854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.