Glucose and Lipid Metabolism Clinical Trial
Official title:
Effects of Aleurone-enriched Products on Fasting and Postprandial Glycemic Homeostasis and Lipid Metabolism in High Cardiovascular Risk Subjects
| Verified date | June 2015 |
| Source | Federico II University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | January 2016 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Dept. Clinical Medicine and Surgery, Federico II University | Naples |
| Lead Sponsor | Collaborator |
|---|---|
| Federico II University |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in fasting and postprandial insulin levels | 8 weeks after the dietary intervention | No |