Clinical trial NCT02150356: 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
Overall status: COMPLETED
Phase: NA
Conditions: Glucose and Lipid Metabolism
Incretin Hormones Plasma Levels
Inflammation, Oxidative Stress and Endothelial Function
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: change in fasting and postprandial insulin levels
timeFrame: 8 weeks after the dietary intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Dept. Clinical Medicine and Surgery, Federico II University
Study officials:
References:
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.