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

March 1, 2018 updated by: Romain Meeusen, Vrije Universiteit Brussel

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high cocoa flavanol drink
high cocoa flavanol drink (900 mg cocoa flavanol dissolved in 300 ml skimmed milk) 2h pre-fMRI
Dietary supplement: cocoa flavanol supplementation
cocoa flavanols (containing 196 mg epicatechin)
Placebo Comparator: 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
Dietary supplement: cocoa flavanol supplementation
cocoa flavanols (containing 196 mg epicatechin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive function
Time Frame: 5 min
reaction time (milliseconds) on the flanker task
5 min
BOLD fmri response
Time Frame: 5 min
blood oxygenation level dependent response during flanker test
5 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vrije Universiteit Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2015

Primary Completion (Actual)

March 15, 2017

Study Completion (Actual)

March 15, 2017

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

March 1, 2018

First Posted (Actual)

March 2, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T1DCFMRI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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