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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452605
• Other study ID #: T1DCFMRI
• Status: Completed
• Phase: N/A
• First received: February 23, 2018
• Last updated: March 1, 2018
• Start date: November 20, 2015
• Est. completion date: March 15, 2017

Study information

• Verified date: March 2018
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 15, 2017
• Est. primary completion date: March 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Dietary Supplement:
• cocoa flavanol supplementation
cocoa flavanols (containing 196 mg epicatechin)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive function	reaction time (milliseconds) on the flanker task	5 min
Primary	BOLD fmri response	blood oxygenation level dependent response during flanker test	5 min