Effects of Aleurone-enriched Products on Cardiovascular Risk Factors

Federico II University

Status

Completed

Conditions

Inflammation, Oxidative Stress and Endothelial Function

Incretin Hormones Plasma Levels

Glucose and Lipid Metabolism

Treatments

Other: Control

Other: Aleurone

Study type

Interventional

Funder types

Other

Identifiers

NCT02150356

ALEURONE Prot 209/2013

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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