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

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.

Study Overview

• Status: Completed
• Conditions: Glucose and Lipid Metabolism; Incretin Hormones Plasma Levels; Inflammation, Oxidative Stress and Endothelial Function
• Intervention / Treatment: Other: Aleurone; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Dept. Clinical Medicine and Surgery, Federico II University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• Costabile G, Vitale M, Della Pepa G, Cipriano P, Vetrani C, Testa R, Mena P, Bresciani L, Tassotti M, Calani L, Del Rio D, Brighenti F, Napoli R, Rivellese AA, Riccardi G, Giacco R. A wheat aleurone-rich diet improves oxidative stress but does not influence glucose metabolism in overweight/obese individuals: Results from a randomized controlled trial. Nutr Metab Cardiovasc Dis. 2022 Mar;32(3):715-726. doi: 10.1016/j.numecd.2021.12.016. Epub 2021 Dec 29.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 26, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): May 29, 2014

Study Record Updates

• Last Update Posted (Estimate): March 7, 2016
• Last Update Submitted That Met QC Criteria: March 3, 2016
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: ALEURONE Prot 209/2013