N/A N=60 Randomized Treatment

Wholegrain Cereal Diet and Insulin Sensitivity

Metabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00945854 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Insulin Sensitivity (Si) — 3.03; 3.15 104xmin-1/microU/ml — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Wholegrain cereal diet (Other); Refined cereal diet (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Federico II University
Primary completion: Mar 2009

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	—

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.

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

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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.