NCT01507259

Brief Summary

The popularity of chocolate can largely be attributed to its mood elevating properties, research shows that it contains antioxidants that also provide physical health benefits. Dark chocolate, in particular, contains high levels of an antioxidant called epicatechin, which is known to cause changes in blood vessels by relaxing them and increasing blood flow. Little is know about the immediate effects of chocolate consumption, or the differences between milk and dark chocolate with regards to these effects. The project will investigate the effect of a single bar of dark or milk chocolate upon blood flow to the brain, using simple ultrasound tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2012

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

First Submitted

Initial submission to the registry

January 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

July 27, 2012

Status Verified

July 1, 2012

First QC Date

January 6, 2012

Last Update Submit

July 26, 2012

Conditions

Keywords

Determine effect on cerebral vasculature

Study Arms (1)

100 g containing 70% or 34% cocoa

Healthy controls

Other: cocoa

Interventions

cocoaOTHER

70% versus 34%

100 g containing 70% or 34% cocoa

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy controls

You may qualify if:

  • No regular medication including vitamins/antioxidants
  • Able to provide informed consent

You may not qualify if:

  • Inability to perform breath-hold test
  • Any known cardiovascular disease, diabetes, throid disease, high blood pressure, hyperlipidaemia or pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

MeSH Terms

Interventions

Chocolate

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sponsor's representative

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 10, 2012

Study Start

February 1, 2012

Study Completion

February 1, 2012

Last Updated

July 27, 2012

Record last verified: 2012-07

Locations