Cardiovascular DiseasesNCT02845622
Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity
A study testing Hazelnut, Cocoa and No hazelnuts / No cocoa in people with Cardiovascular Diseases and Glucose Metabolism Disorders, run by Ospedale San Donato at 1 site in Italy.
Trial summary
This study aims to assess the effects of hazelnuts, cocoa, and the combination of both on vascular reactivity and metabolic profile. Participants, divided in six groups, will receive one of these breakfast integrations for 14 days: group 1) 30 g peeled hazelnuts; group 2) 30 g unpeeled hazelnuts; group 3) snack with… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Glucose Metabolism Disorders
- What is being tested?
- Hazelnut, Cocoa and No hazelnuts / No cocoa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Mar 2015
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.5-24.9 kg/m2
Who cannot join
- diabetes mellitus
- glucose intolerance
- dyslipidemia
- metabolic syndrome
- allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity in Healthy Subjects: A Randomized Controlled Study
This study aims to assess the effects of hazelnuts, cocoa, and the combination of both on vascular reactivity and metabolic profile. Participants, divided in six groups, will receive one of these breakfast integrations for 14 days:
group 1) 30 g peeled hazelnuts;
group 2) 30 g unpeeled hazelnuts;
group 3) snack with 30 g peeled hazelnuts;
group 4) snack with 2.5 g cocoa powder;
group 5) snack with 30 g peeled hazelnuts and 2.5 g cocoa;
group 6) empty snack, control group.
Read the detailed description
In the last few years, the prevalence of overweight and obesity has increased in all age groups. The European Food Safety Authority stated "cocoa flavanols help maintain endothelium-dependent vasodilation, which contributes to normal blood flow". Several studies reported that a daily consumption of hazelnuts reduces the risk of cardiovascular disease. The hypothesis of this study is to demonstrate a beneficial effect of hazelnut and cocoa diet integrations on vascular reactivity and endocrine-metabolic parameters.
- Being tested
- Hazelnut, Cocoa, No hazelnuts / No cocoa, Cream, Snack
- Keywords
- Hazelnut, Cocoa, Flavonoid, Lipids, Vascular Reactivity
- Medical subject headings
- Cardiovascular Diseases, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HazelnutDietary supplement
This dietary supplement contains 30 g of hazelnut.
CocoaDietary supplement
This dietary supplement contains 2.5 g of cocoa powder.
No hazelnuts / No cocoaDietary supplement
This dietary supplement does not contain hazelnut nor cocoa powder.
CreamDietary supplement
This dietary supplement is just a cream obtained by grinding hazelnuts.
SnackDietary supplement
This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.
| Study group | Role | What they receive |
|---|---|---|
| 30g peeled hazelnuts cream | Experimental | Every person in this group will receive a 30 g peeled hazelnuts cream as an integration to his usual breakfast, and will be asked not to change his diet and physical activity during the 2-week trial. Receives: Dietary Supplement: Hazelnut; Dietary Supplement: Cream |
| 30g unpeeled hazelnuts cream | Experimental | Every person in this group will receive a 30 g unpeeled hazelnuts cream as an integration to his usual breakfast, and will be asked not to change his diet and physical activity during the 2-week trial. Receives: Dietary Supplement: Hazelnut; Dietary Supplement: Cream |
| snack w/ 30g peeled hazelnuts | Experimental | Every person in this group will receive a snack with 30 g peeled hazelnuts as an integration to his usual breakfast, and will be asked not to change his diet and physical activity during the 2-week trial. Receives: Dietary Supplement: Hazelnut; Dietary Supplement: Snack |
| snack w/ 2.5g cocoa powder | Experimental | Every person in this group will receive a snack with 2.5 g cocoa powder as an integration to his usual breakfast, and will be asked not to change his diet and physical activity during the 2-week trial. Receives: Dietary Supplement: Cocoa; Dietary Supplement: Snack |
| snack w/ 30g peeled hazelnuts+2.5g cocoa | Experimental | Every person in this group will receive a snack with 30 g peeled hazelnuts and 2.5 g cocoa powder as an integration to his usual breakfast, and will be asked not to change his diet and physical activity during the 2-week trial. Receives: Dietary Supplement: Hazelnut; Dietary Supplement: Cocoa; Dietary Supplement: Snack |
| empty snack | Placebo comparator | Every person in this group will receive an empty snack as an integration to his usual breakfast, and will be asked not to change his diet and physical activity during the 2-week trial. Receives: Dietary Supplement: No hazelnuts / No cocoa; Dietary Supplement: Snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of a breakfast integration on vascular reactivity, assessed by the variation of peak systolic velocity of the brachial artery, in healthy subjects.
Vascular reactivity is measured by assessing the peak systolic velocity (PSV in cm/s) of the brachial artery at rest and after 3 minutes of arterial occlusion using an echographer in Doppler mode. To occlude arterial inflow, a sphygmomanometric cuff is placed above the antecubital fossa and inflated to at least 50 mmHg above systolic pressure for 3 minutes.
Measured: 2 weeks
Secondary outcomes (13)
Effects of a breakfast integration on total cholesterol (mg/dL) in healthy subjects.
Measured: 2 weeks
Effects of a breakfast integration on high-density lipoprotein-cholesterol (mg/dL) in healthy subjects.
Measured: 2 weeks
Effects of a breakfast integration on low-density lipoprotein-cholesterol (mg/dL) in healthy subjects.
Measured: 2 weeks
Effects of a breakfast integration on triglycerides (mg/dL) in healthy subjects.
Measured: 2 weeks
Effects of a breakfast integration on glucose (mg/dL) in healthy subjects.
Measured: 2 weeks
Effects of a breakfast integration on insulin (uU/mL) in healthy subjects.
Measured: 2 weeks
Effects of a breakfast integration on glucagon (pg/mL) in healthy subjects.
Measured: 2 weeks
Effects of a breakfast integration on leptin (ng/mL) in healthy subjects.
Measured: 2 weeks
Effects of a breakfast integration on ghrelin (ng/mL) in healthy subjects.
Measured: 2 weeks
Effects of a breakfast integration on uric acid (mg/dL) in healthy subjects.
Measured: 2 weeks
Effects of a breakfast integration on homocysteine (umol/L) in healthy subjects.
Measured: 2 weeks
Effects of a breakfast integration on ESR (mm/h) in healthy subjects.
Measured: 2 weeks
Effects of a breakfast integration on hs-CRP (mg/dL) in healthy subjects.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Collaborators
- Soremartec Italia S.r.l.
- Responsible party
- Principal investigator, Anna Ferrulli, Ospedale San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845622
- Sponsor's protocol ID
- Nocciola/1
- Status last verified
- Sep 2016
- First submitted
- 21 Jul 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sartori TE, Nunes RA, da Silva GT, da Silva SC, Rondon MU, Negrao CE, Mansur AJ. Influence of demographic and metabolic variables on forearm blood flow and vascular conductance in individuals without overt heart disease. Vasc Health Risk Manag. 2010 Jun 1;6:431-7. doi: 10.2147/vhrm.s10683.
PubMed 20539845Acree LS, Comp PC, Whitsett TL, Montgomery PS, Nickel KJ, Fjeldstad AS, Fjeldstad C, Gardner AW. The influence of obesity on calf blood flow and vascular reactivity in older adults. Dyn Med. 2007 Mar 26;6:4. doi: 10.1186/1476-5918-6-4.
PubMed 17386093Papaioannou GI, Seip RL, Grey NJ, Katten D, Taylor A, Inzucchi SE, Young LH, Chyun DA, Davey JA, Wackers FJ, Iskandrian AE, Ratner RE, Robinson EC, Carolan S, Engel S, Heller GV. Brachial artery reactivity in asymptomatic patients with type 2 diabetes mellitus and microalbuminuria (from the Detection of Ischemia in Asymptomatic Diabetics-brachial artery reactivity study). Am J Cardiol. 2004 Aug 1;94(3):294-9. doi: 10.1016/j.amjcard.2004.04.022.
PubMed 15276091Chandran DS, Jaryal AK, Jyotsna VP, Deepak KK. Impaired endothelium mediated vascular reactivity in endogenous Cushing's syndrome. Endocr J. 2011;58(9):789-99. doi: 10.1507/endocrj.ej11-0030. Epub 2011 Jul 21.
PubMed 21778615
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity in Healthy Subjects: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02845622
- Acronym / sponsor ID
- Nocciola/1
- Keywords
- Hazelnut, Cocoa, Flavonoid, Lipids, Vascular Reactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Collaborators
- Soremartec Italia S.r.l.
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Jul 2016 (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.
This study aims to assess the effects of hazelnuts, cocoa, and the combination of both on vascular reactivity and metabolic profile. Participants, divided in six groups, will receive one of these breakfast integrations for 14 days:
group 1) 30 g peeled hazelnuts;
group 2) 30 g unpeeled hazelnuts;
group 3) snack with 30 g peeled hazelnuts;
group 4) snack with 2.5 g cocoa powder;
group 5) snack with 30 g peeled hazelnuts and 2.5 g cocoa;
group 6) empty snack, control group.
Detailed description
In the last few years, the prevalence of overweight and obesity has increased in all age groups. The European Food Safety Authority stated "cocoa flavanols help maintain endothelium-dependent vasodilation, which contributes to normal blood flow". Several studies reported that a daily consumption of hazelnuts reduces the risk of cardiovascular disease. The hypothesis of this study is to demonstrate a beneficial effect of hazelnut and cocoa diet integrations on vascular reactivity and endocrine-metabolic parameters.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 30g peeled hazelnuts cream | Experimental | Dietary Supplement: Hazelnut, Dietary Supplement: CreamEvery person in this group will receive a 30 g peeled hazelnuts cream as an integration to his usual breakfast, and will be asked not to change his diet and physical activity during the 2-week trial. |
| 30g unpeeled hazelnuts cream | Experimental | Dietary Supplement: Hazelnut, Dietary Supplement: CreamEvery person in this group will receive a 30 g unpeeled hazelnuts cream as an integration to his usual breakfast, and will be asked not to change his diet and physical activity during the 2-week trial. |
| snack w/ 30g peeled hazelnuts | Experimental | Dietary Supplement: Hazelnut, Dietary Supplement: SnackEvery person in this group will receive a snack with 30 g peeled hazelnuts as an integration to his usual breakfast, and will be asked not to change his diet and physical activity during the 2-week trial. |
| snack w/ 2.5g cocoa powder | Experimental | Dietary Supplement: Cocoa, Dietary Supplement: SnackEvery person in this group will receive a snack with 2.5 g cocoa powder as an integration to his usual breakfast, and will be asked not to change his diet and physical activity during the 2-week trial. |
| snack w/ 30g peeled hazelnuts+2.5g cocoa | Experimental | Dietary Supplement: Hazelnut, Dietary Supplement: Cocoa, Dietary Supplement: SnackEvery person in this group will receive a snack with 30 g peeled hazelnuts and 2.5 g cocoa powder as an integration to his usual breakfast, and will be asked not to change his diet and physical activity during the 2-week trial. |
| empty snack | Placebo comparator | Dietary Supplement: No hazelnuts / No cocoa, Dietary Supplement: SnackEvery person in this group will receive an empty snack as an integration to his usual breakfast, and will be asked not to change his diet and physical activity during the 2-week trial. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 18.5-24.9 kg/m2
Key exclusion criteria (5 listed)
- diabetes mellitus
- glucose intolerance
- dyslipidemia
- metabolic syndrome
- allergies
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 |
|---|---|---|
| HazelnutThis dietary supplement contains 30 g of hazelnut. | Dietary supplement | 30g peeled hazelnuts cream, 30g unpeeled hazelnuts cream, snack w/ 30g peeled hazelnuts, snack w/ 30g peeled hazelnuts+2.5g cocoa |
| CocoaThis dietary supplement contains 2.5 g of cocoa powder. | Dietary supplement | snack w/ 2.5g cocoa powder, snack w/ 30g peeled hazelnuts+2.5g cocoa |
| No hazelnuts / No cocoaThis dietary supplement does not contain hazelnut nor cocoa powder. | Dietary supplement | empty snack |
| CreamThis dietary supplement is just a cream obtained by grinding hazelnuts. | Dietary supplement | 30g peeled hazelnuts cream, 30g unpeeled hazelnuts cream |
| SnackThis dietary supplement is a commercial snack containing either hazelnut or cocoa or both. | Dietary supplement | empty snack, snack w/ 2.5g cocoa powder, snack w/ 30g peeled hazelnuts, snack w/ 30g peeled hazelnuts+2.5g cocoa |
Primary outcome
Effects of a breakfast integration on vascular reactivity, assessed by the variation of peak systolic velocity of the brachial artery, in healthy subjects.
Time frame: 2 weeks
Vascular reactivity is measured by assessing the peak systolic velocity (PSV in cm/s) of the brachial artery at rest and after 3 minutes of arterial occlusion using an echographer in Doppler mode. To occlude arterial inflow, a sphygmomanometric cuff is placed above the antecubital fossa and inflated to at least 50 mmHg above systolic pressure for 3 minutes.
13 secondary outcomes
Effects of a breakfast integration on total cholesterol (mg/dL) in healthy subjects.
Time frame: 2 weeks
Effects of a breakfast integration on high-density lipoprotein-cholesterol (mg/dL) in healthy subjects.
Time frame: 2 weeks
Effects of a breakfast integration on low-density lipoprotein-cholesterol (mg/dL) in healthy subjects.
Time frame: 2 weeks
Effects of a breakfast integration on triglycerides (mg/dL) in healthy subjects.
Time frame: 2 weeks
Effects of a breakfast integration on glucose (mg/dL) in healthy subjects.
Time frame: 2 weeks
Effects of a breakfast integration on insulin (uU/mL) in healthy subjects.
Time frame: 2 weeks
Effects of a breakfast integration on glucagon (pg/mL) in healthy subjects.
Time frame: 2 weeks
Effects of a breakfast integration on leptin (ng/mL) in healthy subjects.
Time frame: 2 weeks
Effects of a breakfast integration on ghrelin (ng/mL) in healthy subjects.
Time frame: 2 weeks
Effects of a breakfast integration on uric acid (mg/dL) in healthy subjects.
Time frame: 2 weeks
Effects of a breakfast integration on homocysteine (umol/L) in healthy subjects.
Time frame: 2 weeks
Effects of a breakfast integration on ESR (mm/h) in healthy subjects.
Time frame: 2 weeks
Effects of a breakfast integration on hs-CRP (mg/dL) in healthy subjects.
Time frame: 2 weeks
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 9 Sep 2016.
- Results publication: PubMed 20539845Sartori TE, Nunes RA, da Silva GT, da Silva SC, Rondon MU, Negrao CE, Mansur AJ. Influence of demographic and metabolic variables on forearm blood flow and vascular conductance in individuals without overt heart disease. Vasc Health Risk Manag. 2010 Jun 1;6:431-7. doi: 10.2147/vhrm.s10683.
- Results publication: PubMed 17386093Acree LS, Comp PC, Whitsett TL, Montgomery PS, Nickel KJ, Fjeldstad AS, Fjeldstad C, Gardner AW. The influence of obesity on calf blood flow and vascular reactivity in older adults. Dyn Med. 2007 Mar 26;6:4. doi: 10.1186/1476-5918-6-4.
- Results publication: PubMed 15276091Papaioannou GI, Seip RL, Grey NJ, Katten D, Taylor A, Inzucchi SE, Young LH, Chyun DA, Davey JA, Wackers FJ, Iskandrian AE, Ratner RE, Robinson EC, Carolan S, Engel S, Heller GV. Brachial artery reactivity in asymptomatic patients with type 2 diabetes mellitus and microalbuminuria (from the Detection of Ischemia in Asymptomatic Diabetics-brachial artery reactivity study). Am J Cardiol. 2004 Aug 1;94(3):294-9. doi: 10.1016/j.amjcard.2004.04.022.
- Results publication: PubMed 21778615Chandran DS, Jaryal AK, Jyotsna VP, Deepak KK. Impaired endothelium mediated vascular reactivity in endogenous Cushing's syndrome. Endocr J. 2011;58(9):789-99. doi: 10.1507/endocrj.ej11-0030. Epub 2011 Jul 21.
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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 Hazelnut, Cocoa and No hazelnuts / No cocoa in people with Cardiovascular Diseases and Glucose Metabolism Disorders, run by Ospedale San Donato 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 1 inclusion and 5 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 9 Sep 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?
Effects of a breakfast integration on vascular reactivity, assessed by the variation of peak systolic velocity of the brachial artery, in healthy subjects. (time frame: 2 weeks). 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 NCT02845622, which also lists 4 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 9 Sep 2016.