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

Vrije Universiteit Brussel

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Dietary Supplement: cocoa flavanol supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03452605

T1DCFMRI

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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22 participants in 2 patient groups, including a placebo group

high cocoa flavanol drink

Experimental group

Description:

high cocoa flavanol drink (900 mg cocoa flavanol dissolved in 300 ml skimmed milk) 2h pre-fMRI

Treatment:

Dietary Supplement: cocoa flavanol supplementation

low cocoa flavanol drink

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: cocoa flavanol supplementation