Effects of Aleurone-enriched Products on Cardiovascular Risk Factors (NCT02150356) | Clinical Trial Compass
CompletedNot Applicable
Effects of Aleurone-enriched Products on Cardiovascular Risk Factors
Italy23 participantsStarted 2014-01
Plain-language 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.
Who can participate
Age range
20 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.