Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity

Sponsor

Ospedale San Donato (Other)

Overall Status

Completed

CT.gov ID

NCT02845622

Collaborator

Soremartec Italia S.r.l. (Other)

Enrollment

Location

Arms

Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Glucose Metabolism Disorders	Dietary Supplement: Hazelnut Dietary Supplement: Cocoa Dietary Supplement: No hazelnuts / No cocoa Dietary Supplement: Cream Dietary Supplement: Snack	N/A

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

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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: Cocoa This dietary supplement contains 2.5 g of cocoa powder. Dietary Supplement: Snack This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.
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: Cocoa This dietary supplement contains 2.5 g of cocoa powder. Dietary Supplement: Snack This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.
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: No hazelnuts / No cocoa This dietary supplement does not contain hazelnut nor cocoa powder. Dietary Supplement: Snack This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]