The Effect of a Deep-fried Chocolate Bar or Porridge on Cerebral Blood Flow

August 6, 2013 updated by: NHS Greater Glasgow and Clyde

A Randomised Trial of Effect of Deep-fried Chocolate Bar and Porridge Upon Cerebrovascular Reactivity in Healthy Adult Volunteers

The deep fried chocolate bar is a snack that the international community strongly associates with Scotland. It has previously been cited as being "a symbol of all that is wrong with the high-fat, high-sugar Scottish diet". Despite the snack's reputation, no medical research has been performed to examine the effects of consuming a deep fried chocolate bar on the human body.

In contrast to the deep fried chocolate bar, porridge has been shown to reduce the risk of cardiovascular disease, but its effect on cerebral blood flow has yet to be directly assessed.

This study will focus on the potential (patho)physiological cerebrovascular effects of the deep fried chocolate bar and porridge. The research question to be addressed in this study is "Does eating a deep fried chocolate bar or bowl of porridge induce changes in cerebral blood flow and cereborvascular reactivity in healthy adults?"

To assess the acute effects on eating either food on blood flow through the largest artery in the brain, the investigators will give healthy volunteers one regular-sized deep-fried chocolate bar or a bowl of porridge. Blood flow through the largest artery in the brain will be assessed using simple ultrasounds tests. The investigators aim to recruit 24 volunterrs who will visit twice, consuming a different food on each visit.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI between 18 and 30
  • No regular medication
  • Able to provide informed consent

Exclusion Criteria:

  • Distaste for or contraindication to deep-fried chocolate bar or porridge ingestion
  • inability to perform breath-hold

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: chocolate bar
Dietary supplement: chocolate bar
EXPERIMENTAL: porridge
Dietary supplement: Porridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in breath hold index after ingestion of deep-fried chocolate bar compared with change after porridge ingestion
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

September 1, 2013

Study Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

August 5, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (ESTIMATE)

August 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • GN13MT357

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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