Ageing Gut Brain Interactions

NCT03593941 | Completed

• 1 other identifier: 2/103/17
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia Alzheimers

Keywords

Ageing; Gut Microbiota; Challenging behaviour; Dementia

Outcome Measures

Primary Outcomes (2)

• Faecal sample Short chain fatty acid (SCFA) profile

  Indicator of gut microbiota metabolic activity

  4 months

• Faecal sample Microbiota DNA profile

  Indicator of gut microbiota composition

  4 months

Secondary Outcomes (2)

• Macronutrient composition of care home menu

  4 months

• Frequency of challenging behaviours

  4 months

Other Outcomes (2)

• Willingness to participate in future clinical trial survey

  1 month

• Post-study survey

  1 month

Study Arms (3)

Alzheimer's dementia and challenging behaviour symptoms

Care home residents \>65y No interventions as this is a pilot project

Other: Standard Diet

Alzheimer's dementia and no challenging behavioural symptoms

Care home residents \>65y No interventions as this is a pilot project

Other: Standard Diet

Older adults without dementia

Care home residents \>65y No interventions as this is a pilot project

Other: Standard Diet

Interventions

Standard Diet OTHER

Participants will consume the standard diet provided in care home

Alzheimer's dementia and challenging behaviour symptoms; Alzheimer's dementia and no challenging behavioural symptoms; Older adults without dementia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Care home residents

You may qualify if:

• Resident in a care home

You may not qualify if:

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

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator
• Tenovus Scotland: collaborator

Study Sites (1)

University of Aberdeen

Aberdeen, Grampian, AB25 2ZD, United Kingdom

Location

Related Publications (10)

• Blennow K, de Leon MJ, Zetterberg H. Alzheimer's disease. Lancet. 2006 Jul 29;368(9533):387-403. doi: 10.1016/S0140-6736(06)69113-7.

  PMID: 16876668 BACKGROUND

• Claesson MJ, Jeffery IB, Conde S, Power SE, O'Connor EM, Cusack S, Harris HM, Coakley M, Lakshminarayanan B, O'Sullivan O, Fitzgerald GF, Deane J, O'Connor M, Harnedy N, O'Connor K, O'Mahony D, van Sinderen D, Wallace M, Brennan L, Stanton C, Marchesi JR, Fitzgerald AP, Shanahan F, Hill C, Ross RP, O'Toole PW. Gut microbiota composition correlates with diet and health in the elderly. Nature. 2012 Aug 9;488(7410):178-84. doi: 10.1038/nature11319.

  PMID: 22797518 BACKGROUND

• Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli M, Hall K, Hasegawa K, Hendrie H, Huang Y, Jorm A, Mathers C, Menezes PR, Rimmer E, Scazufca M; Alzheimer's Disease International. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005 Dec 17;366(9503):2112-7. doi: 10.1016/S0140-6736(05)67889-0.

  PMID: 16360788 BACKGROUND

• Fratiglioni L, De Ronchi D, Aguero-Torres H. Worldwide prevalence and incidence of dementia. Drugs Aging. 1999 Nov;15(5):365-75. doi: 10.2165/00002512-199915050-00004.

  PMID: 10600044 BACKGROUND

• Goyal MS, Venkatesh S, Milbrandt J, Gordon JI, Raichle ME. Feeding the brain and nurturing the mind: Linking nutrition and the gut microbiota to brain development. Proc Natl Acad Sci U S A. 2015 Nov 17;112(46):14105-12. doi: 10.1073/pnas.1511465112.

  PMID: 26578751 BACKGROUND

• Lobo A, Launer LJ, Fratiglioni L, Andersen K, Di Carlo A, Breteler MM, Copeland JR, Dartigues JF, Jagger C, Martinez-Lage J, Soininen H, Hofman A. Prevalence of dementia and major subtypes in Europe: A collaborative study of population-based cohorts. Neurologic Diseases in the Elderly Research Group. Neurology. 2000;54(11 Suppl 5):S4-9.

  PMID: 10854354 BACKGROUND

• Mariat D, Firmesse O, Levenez F, Guimaraes V, Sokol H, Dore J, Corthier G, Furet JP. The Firmicutes/Bacteroidetes ratio of the human microbiota changes with age. BMC Microbiol. 2009 Jun 9;9:123. doi: 10.1186/1471-2180-9-123.

  PMID: 19508720 BACKGROUND

• Marchesi JR, Adams DH, Fava F, Hermes GD, Hirschfield GM, Hold G, Quraishi MN, Kinross J, Smidt H, Tuohy KM, Thomas LV, Zoetendal EG, Hart A. The gut microbiota and host health: a new clinical frontier. Gut. 2016 Feb;65(2):330-9. doi: 10.1136/gutjnl-2015-309990. Epub 2015 Sep 2.

  PMID: 26338727 BACKGROUND

• Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007.

  PMID: 23305823 BACKGROUND

• Solfrizzi V, Capurso C, D'Introno A, Colacicco AM, Santamato A, Ranieri M, Fiore P, Capurso A, Panza F. Lifestyle-related factors in predementia and dementia syndromes. Expert Rev Neurother. 2008 Jan;8(1):133-58. doi: 10.1586/14737175.8.1.133.

  PMID: 18088206 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 20, 2018
• Study Start: August 2, 2018
• Primary Completion: August 6, 2019
• Study Completion: January 31, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)