Cardiovascular Diseases, Glucose Metabolism Disorders
Conditions
Keywords
Hazelnut, Cocoa, Flavonoid, Lipids, Vascular Reactivity
Brief 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 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.
Interventions
DIETARY_SUPPLEMENTHazelnut
This dietary supplement contains 30 g of hazelnut.
DIETARY_SUPPLEMENTCocoa
This dietary supplement contains 2.5 g of cocoa powder.
DIETARY_SUPPLEMENTNo hazelnuts / No cocoa
This dietary supplement does not contain hazelnut nor cocoa powder.
DIETARY_SUPPLEMENTCream
This dietary supplement is just a cream obtained by grinding hazelnuts.
DIETARY_SUPPLEMENTSnack
This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.
Sponsors
Soremartec Italia S.r.l.
Ospedale San Donato
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 18.5-24.9 kg/m2
Exclusion criteria
* diabetes mellitus * glucose intolerance * dyslipidemia * metabolic syndrome * allergies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of a breakfast integration on vascular reactivity, assessed by the variation of peak systolic velocity of the brachial artery, in healthy subjects. | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Effects of a breakfast integration on uric acid (mg/dL) in healthy subjects. | 2 weeks |
| Effects of a breakfast integration on homocysteine (umol/L) in healthy subjects. | 2 weeks |
| Effects of a breakfast integration on ESR (mm/h) in healthy subjects. | 2 weeks |
| Effects of a breakfast integration on hs-CRP (mg/dL) in healthy subjects. | 2 weeks |
| Effects of a breakfast integration on total cholesterol (mg/dL) in healthy subjects. | 2 weeks |
| Effects of a breakfast integration on high-density lipoprotein-cholesterol (mg/dL) in healthy subjects. | 2 weeks |
| Effects of a breakfast integration on ghrelin (ng/mL) in healthy subjects. | 2 weeks |
| Effects of a breakfast integration on triglycerides (mg/dL) in healthy subjects. | 2 weeks |
| Effects of a breakfast integration on glucose (mg/dL) in healthy subjects. | 2 weeks |
| Effects of a breakfast integration on insulin (uU/mL) in healthy subjects. | 2 weeks |
| Effects of a breakfast integration on glucagon (pg/mL) in healthy subjects. | 2 weeks |
| Effects of a breakfast integration on leptin (ng/mL) in healthy subjects. | 2 weeks |
| Effects of a breakfast integration on low-density lipoprotein-cholesterol (mg/dL) in healthy subjects. | 2 weeks |
Countries
Italy
Outcome results
None listed