Skip to main content
OpenTrials
Completed

NCT Number: NCT03452605

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

cocoa flavanol supplementation

Dietary Supplement

cocoa flavanols (containing 196 mg epicatechin)

Primary outcomes

  1. cognitive function

    Time frame: 5 min

    reaction time (milliseconds) on the flanker task

  2. BOLD fmri response

    Time frame: 5 min

    blood oxygenation level dependent response during flanker test

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 2, 2018
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.