Effects of Aleurone-enriched Products on Cardiovascular Risk Factors

NCT ID: NCT02150356

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aleurone

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

Group Type: EXPERIMENTAL

Aleurone

Intervention Type: OTHER

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

Control

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

Aleurone

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

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

rivellese angela

Gabriele Riccardi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dept. Clinical Medicine and Surgery, Federico II University

Naples, Italy, Italy

Countries

Italy

References

Testa R, Salamone D, Rivellese AA, Riccardi G, Vitale M, Giacco R, Costabile G. Improving Oxidative Stress Through a Wheat Aleurone-Rich Diet: Are Short-Chain Fatty Acids Possible Mediators? Nutrients. 2025 Oct 20;17(20):3290. doi: 10.3390/nu17203290.

Reference Type: DERIVED

PMID: 41156541 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35123855 (View on PubMed)

Other Identifiers

ALEURONE Prot 209/2013

Identifier Type: -

Identifier Source: org_study_id