An interventional study of Aleurone and Control in Glucose and Lipid Metabolism, Incretin Hormones Plasma Levels and Inflammation, Oxidative Stress and Endothelial Function, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-03-07.
Sponsored by Federico II University · Not applicable, Interventional, and Treatment
Very few studies have evaluated the effect of aleurone-enriched grains on cardiovascular risk factors. Price et al.(2010) have shown that 4-week supplementation of aleurone-enriched products (27 g/day of aleurone) increased betaine concentration in plasma whereas reduced homocysteine and LDL-cholesterol levels. Interestingly, aleurone had no effect on total antioxidant status or endothelial function, whereas an improvement of C-reactive protein was observed (Price RK et al, 2012). It is not known whether consumption of more than 27g/day of aleurone-enriched products with higher ferulic acid biodisponibility and longer time of treatment could influence these parameters in individuals with metabolic syndrome. Noteworthy, no studies have investigated the effect of aleurone-enriched products on fasting and postprandial glycemic homeostasis and lipid metabolism. In addition, mechanisms by which aleurone may act in vivo are still unknown.
The aim of this study is to investigate whether 8 weeks supplementation with aleurone-enriched products may influence glucose and lipid metabolism, incretin hormones levels, satiety, inflammation, oxidative stress and endothelial function in overweight/obese subjects with high cardiovascular risk.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 23 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
At least one of the characteristics of the metabolic syndrome according to the NCEP/ATP III criteria:
Exclusion Criteria:
Diet based in aleurone-enriched products for a period of 8 weeks.
Other: Aleurone
Diet based on refined cereal products for a period of 8 weeks.
Other: Control
Diet based in aleurone-enriched products for a period of 8 weeks.
Diet based on refined cereal products for a period of 8 weeks.
change in fasting and postprandial insulin levels
Time frame: 8 weeks after the dietary intervention
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Federico II University