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

NCT ID: NCT03452605

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-20
• Study Completion Date: 2017-03-15

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

high cocoa flavanol drink

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

Group Type: EXPERIMENTAL

cocoa flavanol supplementation

Intervention Type: DIETARY_SUPPLEMENT

cocoa flavanols (containing 196 mg epicatechin)

low cocoa flavanol drink

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

Group Type: PLACEBO_COMPARATOR

cocoa flavanol supplementation

Intervention Type: DIETARY_SUPPLEMENT

cocoa flavanols (containing 196 mg epicatechin)

Interventions

cocoa flavanol supplementation

cocoa flavanols (containing 196 mg epicatechin)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: lead

Responsible Party

Romain Meeusen

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

T1DCFMRI

Identifier Type: -

Identifier Source: org_study_id