Type 1 Diabetes MellitusNCT03452605
The Effect of Cocoa Flavanol on the BOLD Response and Cognitive Function in Type 1 Diabetes
A study testing cocoa flavanol supplementation in people with Type 1 Diabetes Mellitus, run by Vrije Universiteit Brussel.
Trial summary
Type 1 Diabetes (T1D) is associated with microvascular changes in the brain, which can cause cognitive dysfunction. Cocoa flavanols (CF) can stimulate vasodilation, resulting in enhanced cerebral blood flow and better cognitive function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- cocoa flavanol supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2015to 15 Mar 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non-smoking T1D patients or matched healthy controls
- having diabetes for more than 1 year
- males and females older than 18 years
- stable medications for more than 6 months (no use of cholinesterase inhibitors or prior use of multivitamins was allowed)
- adequate visual and auditory acuity to allow neuropsychological testing.
Who cannot join
- participant enrolled in any investigational drug study within 2 months or longer, depending on the investigational drug half-life
- history in the past 2 years of epileptic seizures or any major psychiatric disorder
- history or MRI evidence of brain damage, including significant trauma, stroke, hydrocephalus, mental retardation, or serious neurological disorder,
- significant history of alcoholism or drug abuse
- unstable cardiac, renal, lung, liver, or other severe chronic disease
- hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pres-sure ≥100 mmHg) or hypotension (systolic blood pressure <100 mmHg)
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- pacemaker or other medical metal devices that precludes performing MRI,
- chronic inflammatory diseases, including lupus, rheumatoid arthritis, or polymyalgia rheumatic
- macrovascular complications
- retinopathy, nephropathy or neuropathy (microvascular complications)
About this study
Official title: Effect of Acute Cocoa Flavanol Intake on the BOLD Response and Cognitive Function in Patients With Type 1 Diabetes
Type 1 Diabetes (T1D) is associated with microvascular changes in the brain, which can cause cognitive dysfunction. Cocoa flavanols (CF) can stimulate vasodilation, resulting in enhanced cerebral blood flow and better cognitive function. This study aimed to investigate whether acute CF supplementation can improve cognitive function and the hemodynamic (BOLD) response in T1D patients.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- cocoa flavanol supplementation
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cocoa flavanol supplementationDietary supplement
cocoa flavanols (containing 196 mg epicatechin)
| Study group | Role | What they receive |
|---|---|---|
| high cocoa flavanol drink | Experimental | high cocoa flavanol drink (900 mg cocoa flavanol dissolved in 300 ml skimmed milk) 2h pre-fMRI Receives: Dietary Supplement: cocoa flavanol supplementation |
| low cocoa flavanol drink | Placebo comparator | low cocoa flavanol drink (30 mg cocoa flavanol dissolved in 300 ml skimmed milk), matched for theobromine, caffeine and macronutrients with the high cocoa flavanol drink 2h-pre fMRI Receives: Dietary Supplement: cocoa flavanol supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function
reaction time (milliseconds) on the flanker task
Measured: 5 min
BOLD fmri response
blood oxygenation level dependent response during flanker test
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start20 Nov 2015
- Primary completion15 Mar 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romain Meeusen, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452605
- Sponsor's protocol ID
- T1DCFMRI
- Status last verified
- Mar 2018
- First submitted
- 23 Feb 2018
- Last updated
- 2 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Cocoa Flavanol Intake on the BOLD Response and Cognitive Function in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03452605
- Acronym / sponsor ID
- T1DCFMRI
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 2 Mar 2018 (actual)
- 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.
Type 1 Diabetes (T1D) is associated with microvascular changes in the brain, which can cause cognitive dysfunction. Cocoa flavanols (CF) can stimulate vasodilation, resulting in enhanced cerebral blood flow and better cognitive function. This study aimed to investigate whether acute CF supplementation can improve cognitive function and the hemodynamic (BOLD) response in T1D patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high cocoa flavanol drink | Experimental | Dietary Supplement: cocoa flavanol supplementationhigh cocoa flavanol drink (900 mg cocoa flavanol dissolved in 300 ml skimmed milk) 2h pre-fMRI |
| low cocoa flavanol drink | Placebo comparator | Dietary Supplement: cocoa flavanol supplementationlow cocoa flavanol drink (30 mg cocoa flavanol dissolved in 300 ml skimmed milk), matched for theobromine, caffeine and macronutrients with the high cocoa flavanol drink 2h-pre fMRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- non-smoking T1D patients or matched healthy controls
- having diabetes for more than 1 year
- males and females older than 18 years
- stable medications for more than 6 months (no use of cholinesterase inhibitors or prior use of multivitamins was allowed)
- adequate visual and auditory acuity to allow neuropsychological testing.
Key exclusion criteria (10 listed)
- participant enrolled in any investigational drug study within 2 months or longer, depending on the investigational drug half-life
- history in the past 2 years of epileptic seizures or any major psychiatric disorder
- history or MRI evidence of brain damage, including significant trauma, stroke, hydrocephalus, mental retardation, or serious neurological disorder,
- significant history of alcoholism or drug abuse
- unstable cardiac, renal, lung, liver, or other severe chronic disease
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 |
|---|---|---|
| cocoa flavanol supplementationcocoa flavanols (containing 196 mg epicatechin) | Dietary supplement | high cocoa flavanol drink, low cocoa flavanol drink |
Primary outcome
cognitive function
Time frame: 5 min
reaction time (milliseconds) on the flanker task
BOLD fmri response
Time frame: 5 min
blood oxygenation level dependent response during flanker test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cocoa flavanol supplementation in people with Type 1 Diabetes Mellitus, run by Vrije Universiteit Brussel.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive function (time frame: 5 min). The study lists 2 primary outcomes in all. 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 2 Mar 2018.