Effects of Aleurone-enriched Products on Cardiovascular Risk Factors
Primary Purpose
Glucose and Lipid Metabolism, Incretin Hormones Plasma Levels, Inflammation, Oxidative Stress and Endothelial Function
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Aleurone
Control
Sponsored by

About this trial
This is an interventional treatment trial for Glucose and Lipid Metabolism
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
Sites / Locations
- Dept. Clinical Medicine and Surgery, Federico II University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aleurone
Control
Arm Description
Diet based in aleurone-enriched products for a period of 8 weeks.
Diet based on refined cereal products for a period of 8 weeks.
Outcomes
Primary Outcome Measures
change in fasting and postprandial insulin levels
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02150356
Brief Title
Effects of Aleurone-enriched Products on Cardiovascular Risk Factors
Official Title
Effects of Aleurone-enriched Products on Fasting and Postprandial Glycemic Homeostasis and Lipid Metabolism in High Cardiovascular Risk Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose and Lipid Metabolism, Incretin Hormones Plasma Levels, Inflammation, Oxidative Stress and Endothelial Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aleurone
Arm Type
Experimental
Arm Description
Diet based in aleurone-enriched products for a period of 8 weeks.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Diet based on refined cereal products for a period of 8 weeks.
Intervention Type
Other
Intervention Name(s)
Aleurone
Intervention Description
Diet based in aleurone-enriched products for a period of 8 weeks.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Diet based on refined cereal products for a period of 8 weeks.
Primary Outcome Measure Information:
Title
change in fasting and postprandial insulin levels
Time Frame
8 weeks after the dietary intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dept. Clinical Medicine and Surgery, Federico II University
City
Naples
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
35123855
Citation
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.
Results Reference
derived
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Effects of Aleurone-enriched Products on Cardiovascular Risk Factors
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