Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity

Cardiovascular Diseases Clinical Trial

Official title:

Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity in Healthy Subjects: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845622
• Other study ID #: Nocciola/1
• Status: Completed
• Phase: N/A
• First received: July 21, 2016
• Last updated: September 7, 2016
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: September 2016
• Source: Ospedale San Donato
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• BMI 18.5-24.9 kg/m2

Exclusion Criteria:

• diabetes mellitus

• glucose intolerance

• dyslipidemia

• metabolic syndrome

• allergies

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Dietary Supplement:
• Hazelnut
This dietary supplement contains 30 g of hazelnut.
• Cocoa
This dietary supplement contains 2.5 g of cocoa powder.
• No hazelnuts / No cocoa
This dietary supplement does not contain hazelnut nor cocoa powder.
• Cream
This dietary supplement is just a cream obtained by grinding hazelnuts.
• Snack
This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.

Locations

Country	Name	City	State
Italy	San Donato Hospital	San Donato Milanese

Sponsors (2)

Lead Sponsor	Collaborator
Ospedale San Donato	Soremartec Italia S.r.l.

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. Epub 2011 Jul 21. — View 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 mel — View Citation

Sartori TE, Nunes RA, da Silva GT, da Silva SC, Rondon MU, Negrão 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks	Yes
Secondary	Effects of a breakfast integration on total cholesterol (mg/dL) in healthy subjects.		2 weeks	Yes
Secondary	Effects of a breakfast integration on high-density lipoprotein-cholesterol (mg/dL) in healthy subjects.		2 weeks	Yes
Secondary	Effects of a breakfast integration on low-density lipoprotein-cholesterol (mg/dL) in healthy subjects.		2 weeks	Yes
Secondary	Effects of a breakfast integration on triglycerides (mg/dL) in healthy subjects.		2 weeks	Yes
Secondary	Effects of a breakfast integration on glucose (mg/dL) in healthy subjects.		2 weeks	Yes
Secondary	Effects of a breakfast integration on insulin (uU/mL) in healthy subjects.		2 weeks	Yes
Secondary	Effects of a breakfast integration on glucagon (pg/mL) in healthy subjects.		2 weeks	Yes
Secondary	Effects of a breakfast integration on leptin (ng/mL) in healthy subjects.		2 weeks	Yes
Secondary	Effects of a breakfast integration on ghrelin (ng/mL) in healthy subjects.		2 weeks	Yes
Secondary	Effects of a breakfast integration on uric acid (mg/dL) in healthy subjects.		2 weeks	Yes
Secondary	Effects of a breakfast integration on homocysteine (umol/L) in healthy subjects.		2 weeks	Yes
Secondary	Effects of a breakfast integration on ESR (mm/h) in healthy subjects.		2 weeks	Yes
Secondary	Effects of a breakfast integration on hs-CRP (mg/dL) in healthy subjects.		2 weeks	Yes