The Cognitive Ageing Nutrition and Neurogenesis (CANN) Trial

NCT02525198 | Completed

• 1 other identifier: R21647
• Study Type: interventional
• Target: 259
• Locations: 3 countries
• Sites: 3

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).

Conditions

Mild Cognitive Impairment; Subjective Memory Impairment

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (11)

• Hippocampal volume

  12 months

• Gut microflora speciation and metabolism

  12 months

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

  12 months

• Circulating biomarkers of cognition

  12 months

• Circulating biomarkers of cardiovascular health

  12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

fatty acid/flavonoid blend

EXPERIMENTAL

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

Dietary Supplement: fatty acid/flavonoid blend

Interventions

fatty acid/flavonoid blend DIETARY_SUPPLEMENT

see arm description

fatty acid/flavonoid blend

Placebo DIETARY_SUPPLEMENT

see arm description

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of East Anglia: lead
• Swinburne University of Technology: collaborator
• University of Illinois at Chicago: collaborator

Study Sites (3)

Beckman Institute, University of Illinois

Urbana, Illinois, 61801, United States

Location

Centre for Human Psychopharmacology, Swinburne Univerity of Technology

Melbourne, Victoria, 3122, Australia

Location

Department of Nutrition, University of East Anglia

Norwich, Norfolk, NR4 7TJ, United Kingdom

Location

Related Publications (2)

• Vauzour D, Scholey A, White DJ, Cohen NJ, Cassidy A, Gillings R, Irvine MA, Kay CD, Kim M, King R, Legido-Quigley C, Potter JF, Schwarb H, Minihane AM. A combined DHA-rich fish oil and cocoa flavanols intervention does not improve cognition or brain structure in older adults with memory complaints: results from the CANN randomized, controlled parallel-design study. Am J Clin Nutr. 2023 Aug;118(2):369-381. doi: 10.1016/j.ajcnut.2023.06.008. Epub 2023 Jun 12.

  PMID: 37315924 DERIVED

• 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.

  PMID: 30426067 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anne Marie Minihane, PhD

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

  PRINCIPAL INVESTIGATOR

• Andrew Scholey, PhD

  Centre for Human Psychopharmacology, Swinburne University of Technology

  PRINCIPAL INVESTIGATOR

• Neal J Cohen, PhD

  Beckman Institute, University of Illinois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: August 17, 2015
• Study Start: August 1, 2015
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: May 14, 2024

Record last verified: 2023-11

Locations

GB (1); US (1); AU (1)