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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Dietary Supplement: cocoa flavanol supplementation

• Registration Number: NCT03452605
• Lead Sponsor: Vrije Universiteit Brussel

Brief 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. This study aimed to investigate whether acute CF supplementation can improve cognitive function and the hemodynamic (BOLD) response in T1D patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-20
• Primary Completion: 2017-03-15
• Study Completion: 2017-03-15
• Study First Submitted: 2018-02-23
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-01
• Last Update Submitted: 2018-03-01
• Study First Posted: 2018-03-02
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
low cocoa flavanol drink	cocoa flavanol supplementation	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
high cocoa flavanol drink	cocoa flavanol supplementation	high cocoa flavanol drink (900 mg cocoa flavanol dissolved in 300 ml skimmed milk) 2h pre-fMRI

Primary Outcome Measures

Name	Time	Method
cognitive function	5 min	reaction time (milliseconds) on the flanker task
BOLD fmri response	5 min	blood oxygenation level dependent response during flanker test