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Completed

NCT Number: NCT02845622

Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity

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.

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Key information

Conditions

Cardiovascular Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Donato Hospital

San Donato Milanese, 20097, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI 18.5-24.9 kg/m2

Exclusion criteria

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

Treatment and study plan

Hazelnut

Dietary Supplement

This dietary supplement contains 30 g of hazelnut.

cocoa

Dietary Supplement

This dietary supplement contains 2.5 g of cocoa powder.

No hazelnuts / No cocoa

Dietary Supplement

This dietary supplement does not contain hazelnut nor cocoa powder.

Cream

Dietary Supplement

This dietary supplement is just a cream obtained by grinding hazelnuts.

Snack

Dietary Supplement

This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.

Primary outcomes

  1. Effects of a breakfast integration on vascular reactivity, assessed by the variation of peak systolic velocity of the brachial artery, in healthy subjects.

    Time frame: 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 outcomes

  1. Effects of a breakfast integration on total cholesterol (mg/dL) in healthy subjects.

    Time frame: 2 weeks

  2. Effects of a breakfast integration on high-density lipoprotein-cholesterol (mg/dL) in healthy subjects.

    Time frame: 2 weeks

  3. Effects of a breakfast integration on low-density lipoprotein-cholesterol (mg/dL) in healthy subjects.

    Time frame: 2 weeks

  4. Effects of a breakfast integration on triglycerides (mg/dL) in healthy subjects.

    Time frame: 2 weeks

  5. Effects of a breakfast integration on glucose (mg/dL) in healthy subjects.

    Time frame: 2 weeks

  6. Effects of a breakfast integration on insulin (uU/mL) in healthy subjects.

    Time frame: 2 weeks

  7. Effects of a breakfast integration on glucagon (pg/mL) in healthy subjects.

    Time frame: 2 weeks

  8. Effects of a breakfast integration on leptin (ng/mL) in healthy subjects.

    Time frame: 2 weeks

  9. Effects of a breakfast integration on ghrelin (ng/mL) in healthy subjects.

    Time frame: 2 weeks

  10. Effects of a breakfast integration on uric acid (mg/dL) in healthy subjects.

    Time frame: 2 weeks

  11. Effects of a breakfast integration on homocysteine (umol/L) in healthy subjects.

    Time frame: 2 weeks

  12. Effects of a breakfast integration on ESR (mm/h) in healthy subjects.

    Time frame: 2 weeks

  13. Effects of a breakfast integration on hs-CRP (mg/dL) in healthy subjects.

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Ospedale San Donato

Other

Collaborators

  • Soremartec Italia S.r.l.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 27, 2016
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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