Effects of Aleurone-enriched Products on Cardiovascular Risk Factors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glucose and Lipid Metabolism Incretin Hormones Plasma Levels Inflammation Inflammation, Oxidative Stress and Endothelial Function Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. Clinical Medicine and Surgery, Federico II University

Naples, Italy, 80131

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aleurone

Other

Diet based in aleurone-enriched products for a period of 8 weeks.

Control

Other

Diet based on refined cereal products for a period of 8 weeks.

Primary outcomes

change in fasting and postprandial insulin levels

Time frame: 8 weeks after the dietary intervention

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: May 29, 2014
Registry last updated: Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed