The study supplementation will be introduced in the daily diet according to the participant preference to a total of 27g of Aleurone/day. One bread bun (35 g) contains 4.8 g Aleurone; one biscuit (15 g) contains 4 g Aleurone; 36 g of RTE cereals contain 9 g Aleurone.

The study supplementation will be introduced in the daily diet according to the participant preference to a total of 27g of Hemicellulose/day. One bread bun (35 g) contains 4.8 g Hemicellulose; one biscuit (15 g) contains 4 g Hemicellulose; 36 g of RTE cereals contain 9 g Hemicellulose. Placebo products contain the same levels of cellulose in place of aleurone's dietary fiber content.

Overweight

Healthy Subjects

Aleurone

Placebo

Fondazione Edmund Mach -Centro Ricerca ed Innovazione

Unità di Dietetica e Nutrizione Clinica, Ospedale S. Chiara, Via Orsi 1

Measuring the Impact of Dietary Supplementation With a High Fiber, High Antioxidant Aleurone on Biomarkers of Cardiovascular Disease and Gut Microbiota in Adults With High Body Mass Index

Change in total plasma homocysteine between timepoints week 2 (baseline) and week 6 (end of dietary supplementation).

plasma metabolites related to homocysteine metabolism (including betaine, dimethylglycine, methionine, choline, folate, riboflavin, vitamin B6).

MS analysis of metabolites related to microbial metabolism.

Faecal microbiota analysis by FISH, qPCR and 454 Roche pyrosequencing

MS analysis of fecal bile acid and fecal sterol concentrations

plasma and urine MS based metabolite profiling;
total cholesterol, triglycerides, LDL-, and HDL-cholesterol levels;
serum glucose and insulin levels;
anthropometric indices;
urinary isoprostane levels;
markers of intestinal permeability in plasma;
C-reactive protein levels as marker of inflammation

Francesca Fava

Fondazione Edmund Mach

Cargill R&D Centre Europe, Havenstraat 84, 1800 Vilvoorde, Belgium

Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento

A subset of individuals started the study period taking monotherapy with simvastatin. After a 12-week period, ezetimibe was combined to the initial monotherapy for more 12 weeks (combination period = experimental).

A subset of individuals started the study period taking monotherapy with ezetimibe. After a 12-week period, simvastin was combined to the initial monotherapy for more 12 weeks (combination period = experimental).

To each subset of individuals which started the study period taking monotherapy with simvastatin or ezetimibe (active comparators), the other drug (ezetimibe or simvastatin, respectively) was combined for more 12 weeks (combination period = experimental arm).

Prediabetes

Hypercholesterolemia

Inflammation

Cardiovascular Risk

Tablets of simvastatin 20 mg administered once a day for 12 weeks

Simvastatin

Tablets of ezetimibe 10 mg administered once a day for 12 weeks

Ezetimibe

Simvastatin 20 mg, once a day, was administered for an additional 12-week period for the subset of individuals who took the initial monotherapy with ezetimibe 10 mg (12 week duration).
Ezetimibe 10 mg, once a day, was administered for an additional 12-week period for the subset of individuals who took the initial monotherapy with simvastatin 20 mg (12 week duration).
This Combination represents the experimental period of the present study.

Combination Simvastatin plus Ezetimibe

Article in press in Metabolism Clinical and Experimental: doi: 10.1016/j.metabol.2010.02.011

Hospital do Rim e Hipertensao da UNIFESP

Effect of Simvastatin and Ezetimibe on Lipid and Inflammation

Synergistic Effect of Simvastatin and Ezetimibe on Lipid and Pro-inflammatory Profiles in Pre-diabetic Subjects

CRP is one of the most important inflammatory marker and its determination has been considered a non-traditional risk factor for several chronic diseases including diabetes and cardiovascular diseases.

Interleukin-6 (IL-6) is a cytokine also produced by the adiposo tissue; its measurement in blood has been used as inflammatory marker for research purposes.

Tumor necrosis factor alfa (TNF-alpha) is secreted by adipose tissue and released to blood. Circulating levels of TNF-alpha may be indicative of a proinflammatory status, which is a initiating mechanism of metabolic and cardiovascular abnormalities.

nterleukin-6 (IL-6) is a cytokine also produced by the adiposo tissue; its measurement in blood has been used as inflammatory marker for research purposes.

sterol/kariyes

Measuring the Impact of Dietary Supplementation With a High Fiber, High Antioxidant Aleurone on Biomarkers of Cardiovascular Disease and Gut Microbiota in Adults With High Body Mass Index

Effect of Simvastatin and Ezetimibe on Lipid and Inflammation

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