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

NCT03452605 | Completed

• 1 other identifier: T1DCFMRI
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• cognitive function

  reaction time (milliseconds) on the flanker task

  5 min

• BOLD fmri response

  blood oxygenation level dependent response during flanker test

  5 min

Study Arms (2)

high cocoa flavanol drink

EXPERIMENTAL

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

Dietary Supplement: cocoa flavanol supplementation

low cocoa flavanol drink

PLACEBO COMPARATOR

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

Interventions

cocoa flavanol supplementation DIETARY_SUPPLEMENT

cocoa flavanols (containing 196 mg epicatechin)

high cocoa flavanol drink; low cocoa flavanol drink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 2, 2018
• Study Start: November 20, 2015
• Primary Completion: March 15, 2017
• Study Completion: March 15, 2017
• Last Updated: March 2, 2018

Record last verified: 2018-03