Trials / Completed
CompletedNCT02150356
Effects of Aleurone-enriched Products on Cardiovascular Risk Factors
Effects of Aleurone-enriched Products on Fasting and Postprandial Glycemic Homeostasis and Lipid Metabolism in High Cardiovascular Risk Subjects
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Federico II University · Academic / Other
- Sex
- All
- Age
- 20 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Glucose and Lipid Metabolism
- Incretin Hormones Plasma Levels
- Inflammation, Oxidative Stress and Endothelial Function
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Aleurone | Diet based in aleurone-enriched products for a period of 8 weeks. |
| OTHER | Control | Diet based on refined cereal products for a period of 8 weeks. |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2015-09-01
- Completion
- 2016-01-01
- First posted
- 2014-05-29
- Last updated
- 2016-03-07
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02150356. Inclusion in this directory is not an endorsement.