Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity

NCT02845622 | Completed DMC

• 1 other identifier: Nocciola/1
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Glucose Metabolism Disorders

Keywords

Hazelnut; Cocoa; Flavonoid; Lipids; Vascular Reactivity

Outcome Measures

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.

  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 Outcomes (13)

• 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

Study Arms (6)

30g peeled hazelnuts cream

EXPERIMENTAL

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; Dietary Supplement: Cream

30g unpeeled hazelnuts cream

EXPERIMENTAL

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; Dietary Supplement: Cream

snack w/ 30g peeled hazelnuts

EXPERIMENTAL

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; Dietary Supplement: Snack

snack w/ 2.5g cocoa powder

EXPERIMENTAL

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; Dietary Supplement: Snack

snack w/ 30g peeled hazelnuts+2.5g cocoa

EXPERIMENTAL

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; Dietary Supplement: Cocoa; Dietary Supplement: Snack

empty snack

PLACEBO COMPARATOR

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; Dietary Supplement: Snack

Interventions

Hazelnut DIETARY_SUPPLEMENT

This dietary supplement contains 30 g of hazelnut.

30g peeled hazelnuts cream; 30g unpeeled hazelnuts cream; snack w/ 30g peeled hazelnuts; snack w/ 30g peeled hazelnuts+2.5g cocoa

Cocoa DIETARY_SUPPLEMENT

This dietary supplement contains 2.5 g of cocoa powder.

snack w/ 2.5g cocoa powder; snack w/ 30g peeled hazelnuts+2.5g cocoa

No hazelnuts / No cocoa DIETARY_SUPPLEMENT

This dietary supplement does not contain hazelnut nor cocoa powder.

empty snack

Cream DIETARY_SUPPLEMENT

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

30g peeled hazelnuts cream; 30g unpeeled hazelnuts cream

Snack DIETARY_SUPPLEMENT

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

empty snack; snack w/ 2.5g cocoa powder; snack w/ 30g peeled hazelnuts; snack w/ 30g peeled hazelnuts+2.5g cocoa

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18.5-24.9 kg/m2

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale San Donato: lead
• Soremartec Italia S.r.l.: collaborator

Study Sites (1)

San Donato Hospital

San Donato Milanese, 20097, Italy

Location

Related Publications (4)

• 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.

  PMID: 20539845 RESULT

• 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.

  PMID: 17386093 RESULT

• 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.

  PMID: 15276091 RESULT

• 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.

  PMID: 21778615 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Glucose Metabolism Disorders

Interventions

Chocolate; Snacks

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Meals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 27, 2016
• Study Start: June 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

IT (1)