Effect on Cerebrovascular ReactivityNCT01918137
The Effect of a Deep-fried Chocolate Bar or Porridge on Cerebral Blood Flow
A study testing chocolate bar and Porridge in people with Effect on Cerebrovascular Reactivity, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
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". Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect on Cerebrovascular Reactivity
- What is being tested?
- chocolate bar and Porridge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18 and 30
- No regular medication
- Able to provide informed consent
Who cannot join
- Distaste for or contraindication to deep-fried chocolate bar or porridge ingestion
- inability to perform breath-hold
Trial locations and contacts
1 site in 1 country.
Matthew Walter, MBChB, MSc, FRCP, MD contact
Erica Packard, PhD contact
United Kingdom1 site
Western Infirmary
Glasgow, G11 6NT
Matthew Walters, MBChB, MSc, FRCP, MD, matthew.waltyers@glasgow.ac.uk
Matthew Walters, MBChB, MSc, FRCP, MD
About this study
Official title: 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.
Read more
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.
- Conditions
- Effect on Cerebrovascular Reactivity
- Being tested
- chocolate bar, Porridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chocolate barDietary supplement
PorridgeDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| chocolate bar | Experimental | Not described Receives: Dietary Supplement: chocolate bar |
| porridge | Experimental | Not described Receives: Dietary Supplement: Porridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breath hold index after ingestion of deep-fried chocolate bar compared with change after porridge ingestion
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect on Cerebrovascular ReactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918137
- Sponsor's protocol ID
- GN13MT357
- Status last verified
- Aug 2013
- First submitted
- 5 Aug 2013
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of Effect of Deep-fried Chocolate Bar and Porridge Upon Cerebrovascular Reactivity in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01918137
- Acronym / sponsor ID
- GN13MT357
- Conditions
- Effect on Cerebrovascular Reactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- Aug 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chocolate bar | Experimental | Dietary Supplement: chocolate bar |
| porridge | Experimental | Dietary Supplement: Porridge |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI between 18 and 30
- No regular medication
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Distaste for or contraindication to deep-fried chocolate bar or porridge ingestion
- inability to perform breath-hold
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chocolate bar | Dietary supplement | chocolate bar |
| Porridge | Dietary supplement | porridge |
Primary outcome
Change in breath hold index after ingestion of deep-fried chocolate bar compared with change after porridge ingestion
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Walter, MBChB, MSc, FRCP, MD contact
Erica Packard, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chocolate bar and Porridge in people with Effect on Cerebrovascular Reactivity, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Walter, MBChB, MSc, FRCP, MD (matthew.walters@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in breath hold index after ingestion of deep-fried chocolate bar compared with change after porridge ingestion (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.