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Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity

Primary Purpose

Cardiovascular Diseases, Glucose Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Hazelnut
Cocoa
No hazelnuts / No cocoa
Cream
Snack
Sponsored by
Ospedale San Donato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Diseases focused on measuring Hazelnut, Cocoa, Flavonoid, Lipids, Vascular Reactivity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 18.5-24.9 kg/m2

Exclusion Criteria:

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

Sites / Locations

  • San Donato Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

30g peeled hazelnuts cream

30g unpeeled hazelnuts cream

snack w/ 30g peeled hazelnuts

snack w/ 2.5g cocoa powder

snack w/ 30g peeled hazelnuts+2.5g cocoa

empty snack

Arm 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.

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.

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.

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.

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.

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.

Outcomes

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.
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.
Effects of a breakfast integration on high-density lipoprotein-cholesterol (mg/dL) in healthy subjects.
Effects of a breakfast integration on low-density lipoprotein-cholesterol (mg/dL) in healthy subjects.
Effects of a breakfast integration on triglycerides (mg/dL) in healthy subjects.
Effects of a breakfast integration on glucose (mg/dL) in healthy subjects.
Effects of a breakfast integration on insulin (uU/mL) in healthy subjects.
Effects of a breakfast integration on glucagon (pg/mL) in healthy subjects.
Effects of a breakfast integration on leptin (ng/mL) in healthy subjects.
Effects of a breakfast integration on ghrelin (ng/mL) in healthy subjects.
Effects of a breakfast integration on uric acid (mg/dL) in healthy subjects.
Effects of a breakfast integration on homocysteine (umol/L) in healthy subjects.
Effects of a breakfast integration on ESR (mm/h) in healthy subjects.
Effects of a breakfast integration on hs-CRP (mg/dL) in healthy subjects.

Full Information

First Posted
July 21, 2016
Last Updated
September 7, 2016
Sponsor
Ospedale San Donato
Collaborators
Soremartec Italia S.r.l.
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1. Study Identification

Unique Protocol Identification Number
NCT02845622
Brief Title
Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity
Official Title
Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity in Healthy Subjects: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Donato
Collaborators
Soremartec Italia S.r.l.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Glucose Metabolism Disorders
Keywords
Hazelnut, Cocoa, Flavonoid, Lipids, Vascular Reactivity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
30g peeled hazelnuts cream
Arm Type
Experimental
Arm 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.
Arm Title
30g unpeeled hazelnuts cream
Arm Type
Experimental
Arm 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.
Arm Title
snack w/ 30g peeled hazelnuts
Arm Type
Experimental
Arm 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.
Arm Title
snack w/ 2.5g cocoa powder
Arm Type
Experimental
Arm 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.
Arm Title
snack w/ 30g peeled hazelnuts+2.5g cocoa
Arm Type
Experimental
Arm 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.
Arm Title
empty snack
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Hazelnut
Intervention Description
This dietary supplement contains 30 g of hazelnut.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cocoa
Intervention Description
This dietary supplement contains 2.5 g of cocoa powder.
Intervention Type
Dietary Supplement
Intervention Name(s)
No hazelnuts / No cocoa
Intervention Description
This dietary supplement does not contain hazelnut nor cocoa powder.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cream
Intervention Description
This dietary supplement is just a cream obtained by grinding hazelnuts.
Intervention Type
Dietary Supplement
Intervention Name(s)
Snack
Intervention Description
This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.
Primary Outcome Measure Information:
Title
Effects of a breakfast integration on vascular reactivity, assessed by the variation of peak systolic velocity of the brachial artery, in healthy subjects.
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Effects of a breakfast integration on total cholesterol (mg/dL) in healthy subjects.
Time Frame
2 weeks
Title
Effects of a breakfast integration on high-density lipoprotein-cholesterol (mg/dL) in healthy subjects.
Time Frame
2 weeks
Title
Effects of a breakfast integration on low-density lipoprotein-cholesterol (mg/dL) in healthy subjects.
Time Frame
2 weeks
Title
Effects of a breakfast integration on triglycerides (mg/dL) in healthy subjects.
Time Frame
2 weeks
Title
Effects of a breakfast integration on glucose (mg/dL) in healthy subjects.
Time Frame
2 weeks
Title
Effects of a breakfast integration on insulin (uU/mL) in healthy subjects.
Time Frame
2 weeks
Title
Effects of a breakfast integration on glucagon (pg/mL) in healthy subjects.
Time Frame
2 weeks
Title
Effects of a breakfast integration on leptin (ng/mL) in healthy subjects.
Time Frame
2 weeks
Title
Effects of a breakfast integration on ghrelin (ng/mL) in healthy subjects.
Time Frame
2 weeks
Title
Effects of a breakfast integration on uric acid (mg/dL) in healthy subjects.
Time Frame
2 weeks
Title
Effects of a breakfast integration on homocysteine (umol/L) in healthy subjects.
Time Frame
2 weeks
Title
Effects of a breakfast integration on ESR (mm/h) in healthy subjects.
Time Frame
2 weeks
Title
Effects of a breakfast integration on hs-CRP (mg/dL) in healthy subjects.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 18.5-24.9 kg/m2 Exclusion Criteria: diabetes mellitus glucose intolerance dyslipidemia metabolic syndrome allergies
Facility Information:
Facility Name
San Donato Hospital
City
San Donato Milanese
ZIP/Postal Code
20097
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20539845
Citation
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.
Results Reference
result
PubMed Identifier
17386093
Citation
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.
Results Reference
result
PubMed Identifier
15276091
Citation
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.
Results Reference
result
PubMed Identifier
21778615
Citation
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.
Results Reference
result

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Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity

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