Effects of Aleurone-enriched Products on Cardiovascular Risk Factors

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Aleurone-enriched Products on Fasting and Postprandial Glycemic Homeostasis and Lipid Metabolism in High Cardiovascular Risk Subjects

Conditions
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Glucose and Lipid Metabolism, Incretin Hormones Plasma Levels, Inflammation, Oxidative Stress and Endothelial Function

Intervention / Treatment
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* Other: Aleurone
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight/obese subjects of both gender Age range between 20 and 70 years High cardiovascular and metabolic risk profile will be enrolled in the study Waist circumference > 102 cm for men, and > 88 cm for women At least one of the characteristics of the metabolic syndrome according to the NCEP/ATP III criteria: Fasting triglycerides ≥150 mg/dl High-density lipoprotein cholesterol <40 mg/dl (men)/<50 mg/dl (women) Blood pressure ≥ 130/85 mmHg Fasting glucose ≥100 mg/dl Exclusion Criteria: Age <20 and >70 years Fasting triglycerides ≥400 mg/dl Fasting cholesterol >270 mg/dl Cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study; established diabetes mellitus or any chronic disease Renal and liver failure (creatinine >1.7 mg/dl and ALT/AST >2 times than normal values, respectively) Anaemia (Hb <12 g /dl) Any chronic disease People treated with antihypertensive drugs will have to keep the type and dosage of medication unchanged during the whole study period

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aleurone<br>Diet based in aleurone-enriched products for a period of 8 weeks. | Other: Aleurone<br>* Diet based in aleurone-enriched products for a period of 8 weeks.<br>|
| Placebo Comparator: Control<br>Diet based on refined cereal products for a period of 8 weeks. | Other: Control<br>* Diet based on refined cereal products for a period of 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in fasting and postprandial insulin levels |  | 8 weeks after the dietary intervention |