Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity

NCT ID: NCT02845622

Last Updated: 2016-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases Glucose Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Hazelnut

Intervention Type DIETARY_SUPPLEMENT

This dietary supplement contains 30 g of hazelnut.

Cream

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

Hazelnut

Intervention Type DIETARY_SUPPLEMENT

This dietary supplement contains 30 g of hazelnut.

Cream

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

Hazelnut

Intervention Type DIETARY_SUPPLEMENT

This dietary supplement contains 30 g of hazelnut.

Snack

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

Cocoa

Intervention Type DIETARY_SUPPLEMENT

This dietary supplement contains 2.5 g of cocoa powder.

Snack

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

Hazelnut

Intervention Type DIETARY_SUPPLEMENT

This dietary supplement contains 30 g of hazelnut.

Cocoa

Intervention Type DIETARY_SUPPLEMENT

This dietary supplement contains 2.5 g of cocoa powder.

Snack

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type PLACEBO_COMPARATOR

No hazelnuts / No cocoa

Intervention Type DIETARY_SUPPLEMENT

This dietary supplement does not contain hazelnut nor cocoa powder.

Snack

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Hazelnut

This dietary supplement contains 30 g of hazelnut.

Intervention Type DIETARY_SUPPLEMENT

Cocoa

This dietary supplement contains 2.5 g of cocoa powder.

Intervention Type DIETARY_SUPPLEMENT

No hazelnuts / No cocoa

This dietary supplement does not contain hazelnut nor cocoa powder.

Intervention Type DIETARY_SUPPLEMENT

Cream

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

Intervention Type DIETARY_SUPPLEMENT

Snack

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI 18.5-24.9 kg/m2

Exclusion Criteria

* diabetes mellitus
* glucose intolerance
* dyslipidemia
* metabolic syndrome
* allergies
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soremartec Italia S.r.l.

UNKNOWN

Sponsor Role collaborator

Ospedale San Donato

OTHER

Sponsor Role lead

Responsible Party

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Anna Ferrulli

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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San Donato Hospital

San Donato Milanese, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 20539845 (View on PubMed)

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.

Reference Type RESULT
PMID: 17386093 (View on PubMed)

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.

Reference Type RESULT
PMID: 15276091 (View on PubMed)

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.

Reference Type RESULT
PMID: 21778615 (View on PubMed)

Other Identifiers

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Nocciola/1

Identifier Type: -

Identifier Source: org_study_id

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