search
Back to results

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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cocoa flavanol supplementation
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    high cocoa flavanol drink

    low cocoa flavanol drink

    Arm Description

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

    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

    Outcomes

    Primary Outcome Measures

    cognitive function
    reaction time (milliseconds) on the flanker task
    BOLD fmri response
    blood oxygenation level dependent response during flanker test

    Secondary Outcome Measures

    Full Information

    First Posted
    February 23, 2018
    Last Updated
    March 1, 2018
    Sponsor
    Vrije Universiteit Brussel
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03452605
    Brief Title
    The Effect of Cocoa Flavanol on the BOLD Response and Cognitive Function in Type 1 Diabetes
    Official Title
    Effect of Acute Cocoa Flavanol Intake on the BOLD Response and Cognitive Function in Patients With Type 1 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 20, 2015 (Actual)
    Primary Completion Date
    March 15, 2017 (Actual)
    Study Completion Date
    March 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vrije Universiteit Brussel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    high cocoa flavanol drink
    Arm Type
    Experimental
    Arm Description
    high cocoa flavanol drink (900 mg cocoa flavanol dissolved in 300 ml skimmed milk) 2h pre-fMRI
    Arm Title
    low cocoa flavanol drink
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    cocoa flavanol supplementation
    Intervention Description
    cocoa flavanols (containing 196 mg epicatechin)
    Primary Outcome Measure Information:
    Title
    cognitive function
    Description
    reaction time (milliseconds) on the flanker task
    Time Frame
    5 min
    Title
    BOLD fmri response
    Description
    blood oxygenation level dependent response during flanker test
    Time Frame
    5 min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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)

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs