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The Cognitive Ageing Nutrition and Neurogenesis (CANN) Trial (CANN)

Primary Purpose

Mild Cognitive Impairment, Subjective Memory Impairment

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

fatty acid/flavonoid blend

Placebo

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild cognitive impairment, Subjective memory impairment, Dementia, Flavonoids, Fatty acids, Cognition, Gut microflora

Eligibility Criteria

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

Inclusion Criteria:

Male and female, aged ≥ 55 years
Mild cognitive impairment (MCI) or subjective memory impairment (SMI) with no indication of clinical dementia or depression
Willing and able to provide written informed consent.
Understands and is willing and able to comply with all study procedures.
Fluent in written and spoken English.
In good general health including blood biochemical, haematological and urinalysis within the normal range at screening (as judged by the clinical advisor)
Normal, or corrected to normal vision and hearing
Right handed, for MRI
Stable use of any prescribed medication for at least four weeks

Exclusion Criteria:

Diagnosis of Alzheimer's disease (AD) or other form of dementia or significant neurological disorder
Parent or sibling who developed premature dementia <60y (suggestive of a familial monogenic form of cognitive decline)
Past history or MRI evidence of brain damage including significant trauma, stroke, learning difficulties or serious neurological disorder, including loss of consciousness > 24 hours
History of alcohol or drug dependency within the last 2 years
Other clinically diagnosed psychiatric disorder likely to affect the cognitive measures (as judged by clinical adviser)
Existing diagnosed gastrointestinal disorders likely to impact on absorption of flavonoids and fatty acids (as judged by clinical adviser)
Major cardiovascular event, e.g. myocardial infarction or stroke, in the last 12 months
Carotid stents or severe stenosis
Known allergy to fish or any other component in the intervention supplements
Existing medical conditions likely to affect the study measures (as judged by clinical adviser)
Uncontrolled hypertension (Systolic Blood Pressure (SBP) >140mmHg, Diastolic Blood Pressure (DBP) >90mmHg)
BMI >40kg/m2

Sites / Locations

Beckman Institute, University of Illinois
Centre for Human Psychopharmacology, Swinburne Univerity of Technology
Department of Nutrition, University of East AngliaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

fatty acid/flavonoid blend

Arm Description

Placebo group: 12 month daily ingestion of placebo oil and flavonoid-poor matched extract

Experimental group: 12 month daily ingestion of 1.5 g EPA+DHA and 500 mg flavonoids

Outcomes

Primary Outcome Measures

Number of false positive responses during the picture recognition task of the CDR Computerized Cognitive Assessment System

The CDR Computerized Cognitive Assessment System will be used to measure the cognitive effects of the treatments. The battery is sensitive to bidirectional cognitive change including trials in MCI, dementia and SMI. There is strong converging evidence that one particular aspect of performance, namely the number of false positive responses during a picture recognition task, is particularly sensitive to hippocampal integrity (based on activation of the dentate gyrus during the task, and specific decrements in conditions associated with poorer hippocampal function). This will form the primary outcome in this study.

Secondary Outcome Measures

Hippocampal volume

To be measured on magnetic resonance imaging

Gut microflora speciation and metabolism

Measured in faecal samples. By extension, we also seek to consider the contribution of the microflora to cognition function and its response to treatment.

Association between baseline APOE status and number of false positive responses during the picture recognition task of the CDR Computerized Cognitive Assessment System

We will assess the impact of intervention in respect to presence or absence of APOE 4 gene across participants, which is a risk factor for dementia.

Circulating biomarkers of cognition

Biomarkers to include BDNF, β-amyloid, plasma lipids, inflammatory markers, nitric oxide and fatty acids, flavonoids and their metabolites (plasma and urine)

Circulating biomarkers of cardiovascular health

Biomarkers to include BDNF, β-amyloid, plasma lipids, inflammatory markers, nitric oxide and fatty acids, flavonoids and their metabolites (plasma and urine)

Language ability on the Boston Naming Test

Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)

Visuospatial ability on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Figure Copy test

Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)

Attention ability on the Digit Span task

Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)

Executive function on the Trail Making Task

Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)

Cerebrovascular blood flow

To be measured on spectroscopy

Measurement of blood brain barrier permeability

Allows testing of the hypothesis that the test food will help improve BBB permeability through its action on endothelial function. Six axial slices will be measured every 1.34 seconds for 8 minutes.

Full Information

NCT ID

NCT02525198

First Posted

May 11, 2015

Last Updated

November 17, 2016

Sponsor

University of East Anglia

Collaborators

Swinburne University of Technology, University of Illinois at Chicago

1. Study Identification

Unique Protocol Identification Number

NCT02525198

Brief Title

The Cognitive Ageing Nutrition and Neurogenesis (CANN) Trial

Acronym

CANN

Official Title

A Randomised Controlled Trial in 'At Risk' Humans Investigating the Cognitive Benefits of a Combined Flavonoid/Fatty Acid Intervention and Underlying Mechanisms of Action: The COGNITIVE AGING NUTRITION and NEUROGENESIS (CANN) Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of East Anglia

Collaborators

Swinburne University of Technology, University of Illinois at Chicago

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

There is a dearth of research which takes a multi-compound approach to dietary interventions, in humans, aimed at improving outcome measures of cognition. Animal research in particular points towards fatty acids and flavonoids having a potentiating effect on each other, and possibly even being synergistic. Thus, study products will be administered in the present trial comprising both of these compounds, with a view to investigating their potential effects on cognition in older adults with mild cognitive impairment (MCI) or subjective memory impairment (SMI).

Detailed Description

240 participants, aged 55 or above, will be recruited (120 Norwich, 120 Melbourne; to include both MCI and SCI participants). Participants will be asked to take the study food each day for 12 months, and to come to the clinical assessment unit on 3 occasions, at baseline, 3 months and 12 months, to complete a cognitive task battery such that their performance may be investigated in the context of the intervention. Urine, blood and faecal samples will be collected and magnetic resonance imaging (MRI) will be applicable to half of each population (i.e to 60 MCI and 60 SCI, 30 of each at Norwich and Melbourne).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment, Subjective Memory Impairment

Keywords

Mild cognitive impairment, Subjective memory impairment, Dementia, Flavonoids, Fatty acids, Cognition, Gut microflora

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo group: 12 month daily ingestion of placebo oil and flavonoid-poor matched extract

Arm Title

fatty acid/flavonoid blend

Arm Type

Experimental

Arm Description

Experimental group: 12 month daily ingestion of 1.5 g EPA+DHA and 500 mg flavonoids

Intervention Type

Dietary Supplement

Intervention Name(s)

fatty acid/flavonoid blend

Intervention Description

see arm description

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

see arm description

Primary Outcome Measure Information:

Title

Number of false positive responses during the picture recognition task of the CDR Computerized Cognitive Assessment System

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Hippocampal volume

Description

To be measured on magnetic resonance imaging

Time Frame

12 months

Title

Gut microflora speciation and metabolism

Description

Measured in faecal samples. By extension, we also seek to consider the contribution of the microflora to cognition function and its response to treatment.

Time Frame

12 months

Title

Association between baseline APOE status and number of false positive responses during the picture recognition task of the CDR Computerized Cognitive Assessment System

Description

We will assess the impact of intervention in respect to presence or absence of APOE 4 gene across participants, which is a risk factor for dementia.

Time Frame

12 months

Title

Circulating biomarkers of cognition

Description

Biomarkers to include BDNF, β-amyloid, plasma lipids, inflammatory markers, nitric oxide and fatty acids, flavonoids and their metabolites (plasma and urine)

Time Frame

12 months

Title

Circulating biomarkers of cardiovascular health

Description

Biomarkers to include BDNF, β-amyloid, plasma lipids, inflammatory markers, nitric oxide and fatty acids, flavonoids and their metabolites (plasma and urine)

Time Frame

12 months

Title

Language ability on the Boston Naming Test

Description

Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)

Time Frame

12 months

Title

Visuospatial ability on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Figure Copy test

Description

Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)

Time Frame

12 months

Title

Attention ability on the Digit Span task

Description

Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)

Time Frame

12 months

Title

Executive function on the Trail Making Task

Description

Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)

Time Frame

12 months

Title

Cerebrovascular blood flow

Description

To be measured on spectroscopy

Time Frame

12 months

Title

Measurement of blood brain barrier permeability

Description

Allows testing of the hypothesis that the test food will help improve BBB permeability through its action on endothelial function. Six axial slices will be measured every 1.34 seconds for 8 minutes.

Time Frame

8 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female, aged ≥ 55 years Mild cognitive impairment (MCI) or subjective memory impairment (SMI) with no indication of clinical dementia or depression Willing and able to provide written informed consent. Understands and is willing and able to comply with all study procedures. Fluent in written and spoken English. In good general health including blood biochemical, haematological and urinalysis within the normal range at screening (as judged by the clinical advisor) Normal, or corrected to normal vision and hearing Right handed, for MRI Stable use of any prescribed medication for at least four weeks Exclusion Criteria: Diagnosis of Alzheimer's disease (AD) or other form of dementia or significant neurological disorder Parent or sibling who developed premature dementia <60y (suggestive of a familial monogenic form of cognitive decline) Past history or MRI evidence of brain damage including significant trauma, stroke, learning difficulties or serious neurological disorder, including loss of consciousness > 24 hours History of alcohol or drug dependency within the last 2 years Other clinically diagnosed psychiatric disorder likely to affect the cognitive measures (as judged by clinical adviser) Existing diagnosed gastrointestinal disorders likely to impact on absorption of flavonoids and fatty acids (as judged by clinical adviser) Major cardiovascular event, e.g. myocardial infarction or stroke, in the last 12 months Carotid stents or severe stenosis Known allergy to fish or any other component in the intervention supplements Existing medical conditions likely to affect the study measures (as judged by clinical adviser) Uncontrolled hypertension (Systolic Blood Pressure (SBP) >140mmHg, Diastolic Blood Pressure (DBP) >90mmHg) BMI >40kg/m2

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anne Marie Minihane, PhD

Phone

+44-1603592389

a.minihane@uea.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

David Vauzour, PhD

Phone

+44-1603 591732

D.Vauzour@uea.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Marie Minihane, PhD

Organizational Affiliation

Department of Nutrition, University of East Anglia, Norwich, U.K.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Andrew Scholey, PhD

Organizational Affiliation

Centre for Human Psychopharmacology, Swinburne University of Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Neal J Cohen, PhD

Organizational Affiliation

Beckman Institute, University of Illinois

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beckman Institute, University of Illinois

City

Urbana

State/Province

Illinois

ZIP/Postal Code

61801

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neal J Cohen, PhD

Phone

217-244-4339

njc@illinois.edu

Facility Name

Centre for Human Psychopharmacology, Swinburne Univerity of Technology

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3122

Country

Australia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrew Scholey, PhD

Phone

+613 9214 8932

ascholey@swin.edu.au

First Name & Middle Initial & Last Name & Degree

Andrew Scholey, PhD

Facility Name

Department of Nutrition, University of East Anglia

City

Norwich

State/Province

Norfolk

ZIP/Postal Code

NR4 7TJ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne Marie Minihane, PhD

Phone

+44-1603592389

A.Minihane@uea.ac.uk

First Name & Middle Initial & Last Name & Degree

Anne Marie Minihane, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

30426067

Citation

Irvine MA, Scholey A, King R, Gillings R, Vauzour D, Demichele SJ, Das T, Wesnes KA, Sutton BP, Cassidy A, Pipingas A, Potter JF, Johnson G, White D, Larsen R, Cohen NJ, Minihane AM. The Cognitive Ageing, Nutrition and Neurogenesis (CANN) trial: Design and progress. Alzheimers Dement (N Y). 2018 Sep 5;4:591-601. doi: 10.1016/j.trci.2018.08.001. eCollection 2018.

Results Reference

derived

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The Cognitive Ageing Nutrition and Neurogenesis (CANN) Trial

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