NCT01681394

Brief Summary

It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce blood pressure. However, the mechanisms implicated in these effects have not been elucidated yet. The purpose of this study is to evaluate changes in gene expression induced by the administration of a polyphenol-rich cocoa extract in peripheral blood mononuclear cells (PBMC) in humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

6 months

First QC Date

September 5, 2012

Last Update Submit

July 2, 2013

Conditions

Cardiovascular FunctionGene Expression

Outcome Measures

Primary Outcomes (1)

  • Gene expression changes in PBMCs (using a microarray)

    0-6 hours

Secondary Outcomes (3)

  • Blood pressure

    0-2-3-6 hours

  • Endothelial function (assessed by ischemic reactive hyperemia)

    0-2-3-6 hours

  • Plasma levels of procyanidins metabolites

    0-6 hours

Study Arms (2)

Product 1

ACTIVE COMPARATOR

250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)

Dietary Supplement: Polyphenol-rich cocoa extract

Control product

PLACEBO COMPARATOR

250 g of chocolate cream

Dietary Supplement: Chocolate cream

Interventions

Polyphenol-rich cocoa extractDIETARY_SUPPLEMENT

250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)

Product 1
Chocolate creamDIETARY_SUPPLEMENT
Control product

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Body mass index (BMI) lower than 18 or greater than 27 Kg/m2
  • Smokers
  • Regular medication
  • Consumption of medication during the last week
  • Following a weight-loss diet
  • Vegetarians
  • Abnormal glucose levels
  • Diabetes
  • Cardiovascular disease
  • Gastrointestinal disease
  • Anemia
  • Allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technological Center of Nutrition and Health (CTNS)

Reus, Tarragona, 43204, Spain

Location

Study Officials

  • Rosa Solà, PhD

    University Rovira i Virgili

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 7, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

July 3, 2013

Record last verified: 2013-07

Locations

ES(1)