Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Glucose Metabolism Disorders
• Intervention / Treatment: Dietary supplement: Hazelnut; Dietary supplement: Cream; Dietary supplement: Snack; Dietary supplement: Cocoa; Dietary supplement: No hazelnuts / No cocoa

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • San Donato Milanese, Italy, 20097
    • San Donato Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI 18.5-24.9 kg/m2

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 30g peeled hazelnuts cream; 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.	Dietary supplement: Hazelnut; This dietary supplement contains 30 g of hazelnut.; Dietary supplement: Cream; This dietary supplement is just a cream obtained by grinding hazelnuts.
EXPERIMENTAL: 30g unpeeled hazelnuts cream; 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.	Dietary supplement: Hazelnut; This dietary supplement contains 30 g of hazelnut.; Dietary supplement: Cream; This dietary supplement is just a cream obtained by grinding hazelnuts.
EXPERIMENTAL: snack w/ 30g peeled hazelnuts; 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.	Dietary supplement: Hazelnut; This dietary supplement contains 30 g of hazelnut.; Dietary supplement: Snack; This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.
EXPERIMENTAL: snack w/ 2.5g cocoa powder; 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.	Dietary supplement: Snack; This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.; Dietary supplement: Cocoa; This dietary supplement contains 2.5 g of cocoa powder.
EXPERIMENTAL: snack w/ 30g peeled hazelnuts+2.5g cocoa; 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.	Dietary supplement: Hazelnut; This dietary supplement contains 30 g of hazelnut.; Dietary supplement: Snack; This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.; Dietary supplement: Cocoa; This dietary supplement contains 2.5 g of cocoa powder.
PLACEBO_COMPARATOR: empty snack; 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.	Dietary supplement: Snack; This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.; Dietary supplement: No hazelnuts / No cocoa; This dietary supplement does not contain hazelnut nor cocoa powder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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 low-density lipoprotein-cholesterol (mg/dL) 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 ghrelin (ng/mL) in healthy subjects.	2 weeks
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

Collaborators and Investigators

• Sponsor: Ospedale San Donato
• Collaborators: Soremartec Italia S.r.l.

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: July 23, 2016
• First Posted (ESTIMATE): July 27, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 9, 2016
• Last Update Submitted That Met QC Criteria: September 7, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Lipids; Cocoa; Flavonoid; Vascular Reactivity; Hazelnut
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: Nocciola/1