Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity

San Donato Group (GSD)

Status: Completed

Conditions: Glucose Metabolism Disorders; Cardiovascular Diseases

Treatments: Dietary Supplement: Hazelnut; Dietary Supplement: Cocoa; Dietary Supplement: No hazelnuts / No cocoa; Dietary Supplement: Cream; Dietary Supplement: Snack

Study type: Interventional

Funder types: Other

Identifiers

NCT02845622

Nocciola/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI 18.5-24.9 kg/m2

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 6 patient groups, including a placebo group

30g peeled hazelnuts cream

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Hazelnut

Dietary Supplement: Cream

30g unpeeled hazelnuts cream

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Hazelnut

Dietary Supplement: Cream

snack w/ 30g peeled hazelnuts

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Hazelnut

Dietary Supplement: Snack

snack w/ 2.5g cocoa powder

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Cocoa

Dietary Supplement: Snack

snack w/ 30g peeled hazelnuts+2.5g cocoa

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Hazelnut

Dietary Supplement: Cocoa

Dietary Supplement: Snack

empty snack

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: No hazelnuts / No cocoa

Dietary Supplement: Snack