DIetary plAnt Extracts, Colonic MicrObes, and Apoe geNetics Interactions stuDy

NCT05905822 | Completed

• 1 other identifier: 319832
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This study will involve donating a salivary sample and a faecal (stool) sample. These will be analysed in the laboratory to determine the forms of the APOE gene you are carrying (your APOE genotype) and the response of the bacteria in your colon to reactive compounds extracted from edible plants (dietary bioactives).

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease Risks; Microbiome; APOE genotype; Metabolism; Cognition

Outcome Measures

Primary Outcomes (2)

• Whether there is a significant difference between the in vitro metabolism of flavan-3-ols using a human colon model

  Participants will be genotyped for their APOE genotype. They will then be requested to donate a stool sample. This stool sample will be run through a colon.model inoculated with flavan-3-ols to determine whether there is a significant difference between the genotypes. Flavan-3-ol metabolism will be measured with LCMS

  09/2025

• Determine whether there are significant differences between the composition of the gut microbiome of each APOE genotype.

  Participants will be genotyped for their APOE genotype. Their stool sample will then have its gut microbiome analysed. Metagenomic techniques will be utilised to analyse the microbiome

  09/2025

Study Arms (2)

Prospectively genotyped participants

These participants will be advertised to in the local area. They will be genotyped for their APOE genotype, and then the stool sample will be collected.

Database participants

Participants from the previously genotyped cohort "Early sleep and circadian markers of Alzheimer's disease: the impact of APOE-ε4 on circadian rhythm and sleep-wake homeostasis in humans" (Reference: 2017/18-135) who have consented to be contacted will be contacted to collect a stool sample.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults who fit the above inclusion and exclusion criteria. Able to donate a stool and salivary sample.

You may qualify if:

• Aged between 18-35 years old or aged 55+ years old
• Fluent in written and spoken English and capacity to consent
• Availability to take part in the study

You may not qualify if:

• Participants will be excluded from donating if they have been diagnosed with any gastrointestinal conditions such as inflammatory bowel disease.
• They will also be excluded if they have a diagnosis of any form of dementia or severe cognitive impairment.
• They currently consume a high flavonoid intake defined as \>15 portions of flavonoid rich food per day.
• History or MRI evidence of brain damage, including significant trauma, stroke, learning difficulties or serious neurological disorder, including a loss of consciousness for more than 24 hours.
• Currently smoking or ceased smoking less than 6 months ago.
• Chronic fatigue syndrome, liver disease, diabetes mellitus, or gall bladder abnormalities.
• History of alcohol or drug dependency.
• Clinically diagnosed psychiatric disorder.
• Currently a participant or have been a participant in any other study involving an investigational product within the last 4 weeks.
• Received a COVID-19 diagnosis within the last 30 days

Sponsors & Collaborators

• University of East Anglia: lead
• Quadram Institute Bioscience: collaborator

Study Sites (1)

Norwich and Norfolk University Hospital Clinical Research Facility

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Related Publications (2)

• Raulin AC, Doss SV, Trottier ZA, Ikezu TC, Bu G, Liu CC. ApoE in Alzheimer's disease: pathophysiology and therapeutic strategies. Mol Neurodegener. 2022 Nov 8;17(1):72. doi: 10.1186/s13024-022-00574-4.

  PMID: 36348357 BACKGROUND

• Seals RR Jr, Morrow RM, Kuebker WA. The dentist's role in Texas high school mouthguard programs. Tex Dent J. 1984 Oct;101(10):6-9. No abstract available.

  PMID: 6593891 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Salivary sample Stool sample

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• David Vauzour, PhD

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: June 19, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-10

Locations

GB (1)