Clinical trial NCT02845622: Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity
Official title: Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity in Healthy Subjects: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Glucose Metabolism Disorders
Keywords: Hazelnut
Cocoa
Flavonoid
Lipids
Vascular Reactivity
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
Collaborators: name: Soremartec Italia S.r.l.
First posted: 2016-07-27
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* BMI 18.5-24.9 kg/m2

Exclusion Criteria:

* diabetes mellitus
* glucose intolerance
* dyslipidemia
* metabolic syndrome
* allergies

Primary outcomes:
measure: Effects of a breakfast integration on vascular reactivity, assessed by the variation of peak systolic velocity of the brachial artery, in healthy subjects.
timeFrame: 2 weeks
Secondary outcomes:
measure: Effects of a breakfast integration on total cholesterol (mg/dL) in healthy subjects.
timeFrame: 2 weeks
measure: Effects of a breakfast integration on high-density lipoprotein-cholesterol (mg/dL) in healthy subjects.
timeFrame: 2 weeks
measure: Effects of a breakfast integration on low-density lipoprotein-cholesterol (mg/dL) in healthy subjects.
timeFrame: 2 weeks
measure: Effects of a breakfast integration on triglycerides (mg/dL) in healthy subjects.
timeFrame: 2 weeks
measure: Effects of a breakfast integration on glucose (mg/dL) in healthy subjects.
timeFrame: 2 weeks
measure: Effects of a breakfast integration on insulin (uU/mL) in healthy subjects.
timeFrame: 2 weeks
measure: Effects of a breakfast integration on glucagon (pg/mL) in healthy subjects.
timeFrame: 2 weeks
measure: Effects of a breakfast integration on leptin (ng/mL) in healthy subjects.
timeFrame: 2 weeks
measure: Effects of a breakfast integration on ghrelin (ng/mL) in healthy subjects.
timeFrame: 2 weeks
measure: Effects of a breakfast integration on uric acid (mg/dL) in healthy subjects.
timeFrame: 2 weeks
measure: Effects of a breakfast integration on homocysteine (umol/L) in healthy subjects.
timeFrame: 2 weeks
measure: Effects of a breakfast integration on ESR (mm/h) in healthy subjects.
timeFrame: 2 weeks
measure: Effects of a breakfast integration on hs-CRP (mg/dL) in healthy subjects.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: San Donato Hospital
Study officials:
References:
citation: 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.
citation: Acree 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.
citation: Papaioannou 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.
citation: Chandran 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.