NCT02150356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 7, 2016

Status Verified

June 1, 2015

Enrollment Period

1.7 years

First QC Date

May 26, 2014

Last Update Submit

March 3, 2016

Conditions

Glucose and Lipid MetabolismIncretin Hormones Plasma LevelsInflammation, Oxidative Stress and Endothelial Function

Outcome Measures

Primary Outcomes (1)

  • change in fasting and postprandial insulin levels

    8 weeks after the dietary intervention

Study Arms (2)

Aleurone

EXPERIMENTAL

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

Other: Aleurone

Control

PLACEBO COMPARATOR

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

Other: Control

Interventions

AleuroneOTHER

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

Aleurone
ControlOTHER

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

Control

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Clinical Medicine and Surgery, Federico II University

Naples, Italy, 80131, Italy

Location

Related Publications (2)

  • 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.

    PMID: 41156541DERIVED

  • 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.

    PMID: 35123855DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

aleurone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gabriele Riccardi

Study Record Dates

First Submitted

May 26, 2014

First Posted

May 29, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

January 1, 2016

Last Updated

March 7, 2016

Record last verified: 2015-06

Locations

IT(1)