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Ageing Gut Brain Interactions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03593941
Recruitment Status : Unknown
Verified July 2018 by University of Aberdeen.
Recruitment status was:  Recruiting
First Posted : July 20, 2018
Last Update Posted : August 1, 2018
Sponsor:
Collaborators:
NHS Grampian
Tenovus Scotland
Information provided by (Responsible Party):
University of Aberdeen

Brief Summary:

This research project will address a desperate need for evidence on how diet could be used to treat and improve symptoms of Alzheimer's disease (AD). It has been estimated that 36 million people have dementia worldwide, and in older people Alzheimer's disease accounts for 60-70% of all dementia. Research supports the hypothesis that modifiable lifestyle-related factors are associated with cognitive decline, which opens new avenues for prevention or modification of disease.

The concept that inspires this proposal 'Ageing-Gut-Brain Interactions study' is that the gut microbiota impact upon the gut-brain axis and thereby on behaviour, including challenging behaviours often associated with dementia. In the absence of available cures for Alzheimer's disease, diet is an important modifiable component but knowledge about the role of diet in clinical symptoms of dementia is currently very limited. A recent study from Ireland from the European Union funded Nu-Age cohort reported that the gut microbiota profile in the elderly was different between community-living and institutionalized individuals, with specific microbiome profiles correlating with frailty and poor health.

Changes in dietary composition and diversity were considered the main drivers of the shifts in gut bacteria profile. In this multi-disciplinary research study, the investigators will assess the gut microbiota composition in people with Alzheimer's dementia with and without challenging behaviours; test the feasibility of recruitment; and provide initial data to support a future grant application involving a dietary intervention study in patients with Alzheimer's disease.

The investigators will test the hypothesis that the gut-brain axis promotes behavioural changes in Alzheimer's dementia and is responsive to changes in gut microbiota profile, by comparing the gut microbiota profile between three participant groups (1) Alzheimer's dementia with challenging behaviour, (2) Alzheimer's dementia without challenging behaviour, and (3) a control group of healthy age-matched elderly. The investigators will also carry out a survey of care homes to assess willingness to participate in a future dietary supplementation study.


Condition or disease Intervention/treatment
Dementia Alzheimers Other: Standard Diet

Detailed Description:

Introduction

Healthy life expectancy is a key area of research. It has been estimated that 36 million people have dementia worldwide and that there are 4.6 million new cases of dementia every year. Epidemiological evidence supports the hypothesis that modifiable lifestyle-related factors are associated with cognitive decline, opening new avenues for prevention. Alzheimer's disease is the commonest cause of dementia in older people, accounting for 60-70% of all dementia cases when using traditional diagnostic criteria for dementia subtypes.

There are no available cures for AD, but an alternative approach is to use strategies that delay disease progression at an early stage. Optimal brain function results from highly complex interactions between numerous genetic and environmental factors, including food intake, physical activity, age and stress. Diet in particular has become the object of intense research in relation to cognitive aging and neurodegenerative diseases.

The gut microbiota is a large, diverse collection of microbes, collectively containing 100 times more genes than the host. It is host-specific, contains heritable components, can be modified by diet, surgery or antibiotics, and in its absence nearly all aspects of host physiology are affected. It is now realised that the human microbiota is a previously overlooked system that makes a significant contribution to human biology and development.There is a new and exciting field of research with limited published data in the elderly, that could provide a basis for the design of novel, microbiota-targeted, therapies to improve care of older people suffering from Alzheimer's dementia.

There is increasing evidence that identifies the gut microbiota as a key conduit between nutrition and brain function. Reduction in the frequency of genes encoding short chain fatty acid (SCFA) production was prominent among institutionalized older adults, as were increases in circulating pro-inflammatory cytokines tumour necrosis factor-alpha, interleukins-6 and -8, and C-reactive protein.

Rationale for Study

Hypothesis: The composition and/or diversity of the gut microbiota is different between healthy elderly and those with Alzheimer's dementia, who do or do not exhibit behaviour(s) that are challenging.

The concept that inspires Ageing-GB is that our gut microbiota impact upon the gut-brain axis and thereby on behaviour. There is a need to understand the nature of that impact, the underlying mechanisms, and how changes in diet can reprogram our gut microbiota-brain axis to resolve or reduce clinical symptoms associated with Alzheimer's dementia.

However, to the investigator's knowledge, there has been no published work to examine the gut microbiota profile in patients with Alzheimer's disease. Consequently, the investigators first need to demonstrate the differences in microbiota profile between AD patients with or without behaviours that are more challenging to manage. This work is anticipated to provide fundamental evidence to support dietary modification or supplementation as cost-effective and safe avenues for alleviating signs and symptoms of dementia in this vulnerable group and thus reduce the carer burden.

This study will require the co-operation of care home managers and staff, and investigators will thus simultaneously assess the feasibility of performing a nutritional intervention study in this group of individuals, in this setting.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Ageing Gut Brain Interactions
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018


Group/Cohort Intervention/treatment
Alzheimer's dementia and challenging behaviour symptoms
Care home residents >65y No interventions as this is a pilot project
Other: Standard Diet
Participants will consume the standard diet provided in care home

Alzheimer's dementia and no challenging behavioural symptoms
Care home residents >65y No interventions as this is a pilot project
Other: Standard Diet
Participants will consume the standard diet provided in care home

Older adults without dementia
Care home residents >65y No interventions as this is a pilot project
Other: Standard Diet
Participants will consume the standard diet provided in care home




Primary Outcome Measures :
  1. Faecal sample Short chain fatty acid (SCFA) profile [ Time Frame: 4 months ]
    Indicator of gut microbiota metabolic activity

  2. Faecal sample Microbiota DNA profile [ Time Frame: 4 months ]
    Indicator of gut microbiota composition


Secondary Outcome Measures :
  1. Macronutrient composition of care home menu [ Time Frame: 4 months ]
    The weekly care home menu will be analysed for the macronutrient contents (carbohydrate, fat and protein)

  2. Frequency of challenging behaviours [ Time Frame: 4 months ]
    Log of the number of incidents of participant displaying challenging behaviours requiring care home staff intervention


Other Outcome Measures:
  1. Willingness to participate in future clinical trial survey [ Time Frame: 1 month ]
    Survey Monkey questionnaire

  2. Post-study survey [ Time Frame: 1 month ]
    Feedback survey on how participants found their experience



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Care home residents
Criteria

Inclusion Criteria:

  • Resident in a care home

Exclusion Criteria:

  • Use of antibiotics in last 8 weeks
  • Active gastrointestinal disease
  • Unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593941


Locations
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United Kingdom
University of Aberdeen Recruiting
Aberdeen, Grampian, United Kingdom, AB25 2ZD
Contact: Alexandra Johnstone, BSc, MSc, PhD, PGCE, RNutr    01224438701    alex.johnstone@abdn.ac.uk   
Sub-Investigator: Alexandra Johnstone, BSc, MSc, PhD, PGCE, RNutr         
Principal Investigator: Phyo Myint, MBBS, MD, FRCP (Edin/Lond)         
Sub-Investigator: Karen Scott, BSc, PhD         
Sub-Investigator: Emma Law, PhD         
Sub-Investigator: Alison Donaldson, MBChB, BScMedSci, MRCP         
Sub-Investigator: Roy Soiza, MBChB MRCP         
Sponsors and Collaborators
University of Aberdeen
NHS Grampian
Tenovus Scotland
  Study Documents (Full-Text)

Documents provided by University of Aberdeen:
Publications:

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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT03593941    
Other Study ID Numbers: 2/103/17
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aberdeen:
Ageing
Gut Microbiota
Challenging behaviour
Dementia
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases