Glucose and Lipid MetabolismNCT02150356
Effects of Aleurone-enriched Products on Cardiovascular Risk Factors
A study testing Aleurone in people with Glucose and Lipid Metabolism and Incretin Hormones Plasma Levels, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Glucose and Lipid Metabolism, Incretin Hormones Plasma Levels, Inflammation, Oxidative Stress and Endothelial Function
- What is being tested?
- Aleurone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- High-density lipoprotein cholesterol <40 mg/dl (men)/<50 mg/dl (women)
- Blood pressure ≥ 130/85 mmHg
- Fasting glucose ≥100 mg/dl
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dept. Clinical Medicine and Surgery, Federico II University
Naples, Italy, 80131
About this study
Official title: Effects of Aleurone-enriched Products on Fasting and Postprandial Glycemic Homeostasis and Lipid Metabolism in High Cardiovascular Risk Subjects
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.
- Conditions
- Glucose and Lipid Metabolism, Incretin Hormones Plasma Levels, Inflammation, Oxidative Stress and Endothelial Function
- Being tested
- Aleurone, Control
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AleuroneOther
Diet based in aleurone-enriched products for a period of 8 weeks.
ControlOther
Diet based on refined cereal products for a period of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aleurone | Experimental | Diet based in aleurone-enriched products for a period of 8 weeks. Receives: Other: Aleurone |
| Control | Placebo comparator | Diet based on refined cereal products for a period of 8 weeks. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in fasting and postprandial insulin levels
Measured: 8 weeks after the dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glucose and Lipid MetabolismStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rivellese angela, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150356
- Sponsor's protocol ID
- ALEURONE Prot 209/2013
- Status last verified
- Jun 2015
- First submitted
- 26 May 2014
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 41156541Costabile 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.
PubMed 35123855
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aleurone-enriched Products on Fasting and Postprandial Glycemic Homeostasis and Lipid Metabolism in High Cardiovascular Risk Subjects
- ClinicalTrials.gov ID
- NCT02150356
- Acronym / sponsor ID
- ALEURONE Prot 209/2013
- Conditions
- Glucose and Lipid Metabolism, Incretin Hormones Plasma Levels, Inflammation, Oxidative Stress and Endothelial Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aleurone | Experimental | Other: AleuroneDiet based in aleurone-enriched products for a period of 8 weeks. |
| Control | Placebo comparator | Other: ControlDiet based on refined cereal products for a period of 8 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AleuroneDiet based in aleurone-enriched products for a period of 8 weeks. | Other | Aleurone |
| ControlDiet based on refined cereal products for a period of 8 weeks. | Other | Control |
Primary outcome
change in fasting and postprandial insulin levels
Time frame: 8 weeks after the dietary intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Derived from this study: PubMed 41156541Testa 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.
- Derived from this study: PubMed 35123855Costabile 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aleurone in people with Glucose and Lipid Metabolism and Incretin Hormones Plasma Levels, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in fasting and postprandial insulin levels (time frame: 8 weeks after the dietary intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02150356, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.