The Effect of Cocoa Flavanol on the BOLD Response and Cognitive Function in Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Acute Cocoa Flavanol Intake on the BOLD Response and Cognitive Function in Patients With Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: cocoa flavanol supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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) 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high cocoa flavanol drink<br>high cocoa flavanol drink (900 mg cocoa flavanol dissolved in 300 ml skimmed milk) 2h pre-fMRI | Dietary Supplement: cocoa flavanol supplementation<br>* cocoa flavanols (containing 196 mg epicatechin)<br>|
| Placebo Comparator: low cocoa flavanol drink<br>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 | Dietary Supplement: cocoa flavanol supplementation<br>* cocoa flavanols (containing 196 mg epicatechin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function | reaction time (milliseconds) on the flanker task | 5 min | 
| BOLD fmri response | blood oxygenation level dependent response during flanker test | 5 min |