NCT00511420

Brief Summary

The purpose of this study is to evaluate the effects of optimized composition chocolates that include natural ingredients with demonstrated biological activity are observed cardioprotectores effects in the human.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at below P25 for phase_3 cardiovascular-diseases

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_3 cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2007

Completed
Last Updated

August 3, 2007

Status Verified

August 1, 2007

First QC Date

August 2, 2007

Last Update Submit

August 2, 2007

Conditions

Cardiovascular Diseases

Keywords

cocoacardiovascular diseaseblood pressure

Outcome Measures

Primary Outcomes (1)

  • Blood pressure changes between baseline and the end of intervention

    4 weeks

Secondary Outcomes (2)

  • Plasma lipids, lipoproteins and apolipoproteins

    4 weeks

  • Endothelial dysfunction, oxidation and inflammation markers

    4 weeks

Study Arms (4)

1

PLACEBO COMPARATOR

Cocoa and other ingredients (product type 1). This product is a control of type 2.

Dietary Supplement: Cocoa product type 1

2

PLACEBO COMPARATOR

Cocoa plus hazelnuts and other ingredients (product type 2). This product is a control of type 3 and 4.

Dietary Supplement: Cocoa product type 2

3

ACTIVE COMPARATOR

Cocoa plus hazelnuts and other ingredients (cocoa product type 3).

Dietary Supplement: Cocoa product type 3

4

ACTIVE COMPARATOR

Cocoa, hazelnuts and other ingredients called LMN (cocoa product type 4).

Dietary Supplement: Cocoa product type 4

Interventions

Cocoa product type 1DIETARY_SUPPLEMENT

6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks.

1
Cocoa product type 2DIETARY_SUPPLEMENT

6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1

2
Cocoa product type 3DIETARY_SUPPLEMENT

6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1

3
Cocoa product type 4DIETARY_SUPPLEMENT

6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1

4

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible participants had systolic blood pressure (BP) of 120 to 159 mm Hg or a diastolic blood pressure of 80 to 99 mm Hg. This range includes participants with prehypertension (systolic, 120-139 mm Hg or diastolic, 80-89 mm Hg) and stage 1 hypertension (systolic, 140-159 mm Hg or diastolic, 90-99 mm Hg).
  • Moreover, participants' plasma LDL-cholesterol concentrations were ≥ 3.35 mmol/L (≥ 130 and ≤ 189 mg/dL) and triglyceride concentrations \< 4 mmol/L (350 mg/dL) in the fasting state and at least one CVD risk factor such as age (men ≥45 years; women ≥55 years), cigarette smoking, low high density lipoprotein cholesterol concentration (\<1.0 mmol/L (40 mg/dL) and \<1,18 mmol/L (46 mg/dL), men and women, respectively), family history of premature CVD (in male first-degree relative \<55 years of age, in female first-degree relative \<65 years of age.

You may not qualify if:

  • Assessed from the medical history and a complete physical examination, were plasma triglyceride concentrations ≥4 mmol/L (350 mg/dL), BMI \>35 kg/m2, CVD clinical events, use of lipid-lowering drugs at least 2 months prior to the start of study, diabetes mellitus (at least 2 fasting glucose ≥7.0 mmol/L (≥ 126 mg/dL), renal insufficiency, thyroid or other endocrine disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Rovira i Virgili and Hospital Universitari Sant Joan

Reus, Tarragona, 43201, Spain

Location

Related Publications (2)

  • Crescenti A, Sola R, Valls RM, Caimari A, Del Bas JM, Anguera A, Angles N, Arola L. Cocoa Consumption Alters the Global DNA Methylation of Peripheral Leukocytes in Humans with Cardiovascular Disease Risk Factors: A Randomized Controlled Trial. PLoS One. 2013 Jun 26;8(6):e65744. doi: 10.1371/journal.pone.0065744. Print 2013.

    PMID: 23840361DERIVED

  • Sola R, Valls RM, Godas G, Perez-Busquets G, Ribalta J, Girona J, Heras M, Cabre A, Castro A, Domenech G, Torres F, Masana L, Angles N, Reguant J, Ramirez B, Barriach JM. Cocoa, hazelnuts, sterols and soluble fiber cream reduces lipids and inflammation biomarkers in hypertensive patients: a randomized controlled trial. PLoS One. 2012;7(2):e31103. doi: 10.1371/journal.pone.0031103. Epub 2012 Feb 27.

    PMID: 22383996DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Rosa Sola, Dra/Prof

    University Rovira i Virgili

    PRINCIPAL INVESTIGATOR

  • Bartolome Ramirez, Mr

    La Morella Nuts, S.A.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2007

First Posted

August 3, 2007

Study Start

April 1, 2005

Study Completion

December 1, 2005

Last Updated

August 3, 2007

Record last verified: 2007-08

Locations

ES(1)