The Impact of Cranberries On the Microbiome and the Brain in Healthy Ageing sTudy (COMBAT)

NCT ID: NCT03679533

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-02
• Study Completion Date: 2020-05-22

Brief Summary

Tremendous progress has been made in characterizing the interactions between the central nervous system and the gastrointestinal tract. This concept of a gut-brain axis suggests that influencing bacteria in the gut is a promising approach for developing new ways of benefiting brain function. This is particularly relevant for an ageing population for which cognitive decline is a common symptom and can be an indicator for the development of neurodegenerative conditions such as dementia. There is good evidence already that nutrition can delay the development of cognitive decline in ageing, in particular for ageing-sensitive brain regions such as the medial temporal lobe, however this has been little explored for cranberry intake. Cranberries are high in plant-derived nutrients called polyphenols, which have been suggested to promote brain function and protect against disease-causing mechanisms. In the proposed project we will pioneer work to investigate the impact of cranberry intake on gut bacteria and how it relates to cognitive performance in ageing and associated regions in the brain.

This study is being conducted by Chief Investigators Dr David Vauzour and Prof Michael Hornberger at the University of East Anglia. Sixty participants (i.e. n=30 control and treatment groups) aged 50-80 years old, with no memory complaints will be recruited for this 12-week double-blind placebo-controlled parallel intervention of cranberry flavonoids. Freeze-dried cranberry or a matched placebo will be taken twice daily for the duration of the trial. Blood, urine and faecal samples will be collected for microbiome, DNA, biochemical and nutritional analysis. Participants will also undergo cognitive testing, as well as MRI scanning to detect changes in brain physiology.

Conditions

Aging; Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Active Cranberry Study Food

Group Type: ACTIVE_COMPARATOR

Freeze-Dried Cranberry Powder

Intervention Type: DIETARY_SUPPLEMENT

Freeze-dried cranberry powder (or matched placebo), approximating 500mg active flavonoids per day, taken twice daily for 12 weeks.

Placebo Study Food

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo food powder matched for taste, colour, energy and macronutrient content to the active cranberry powder.

Interventions

Freeze-Dried Cranberry Powder

Freeze-dried cranberry powder (or matched placebo), approximating 500mg active flavonoids per day, taken twice daily for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo food powder matched for taste, colour, energy and macronutrient content to the active cranberry powder.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Aged between 50 and 80 years old.
• Willing and able to provide written informed consent.
• Fluent in written and spoken English.
• Normal or corrected to normal vision and hearing.
• Understands and is willing and able to comply with all study procedures.

Exclusion Criteria

• Diagnosis of any form of dementia or significant neurological condition.
• Significant memory complaints.
• Past 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.
• Existing diagnosed gastrointestinal disorders likely to impact on absorption of flavonoids.
• Known allergy to the intervention supplement.
• Any significant medical condition likely to affect participation.
• Currently a participant or have been a participant in any other study involving an investigational product within the last 4 weeks.
• Uncontrolled hypertension (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg).
• Major cardiovascular event, such as myocardial infarction, within the last 12 months.
• On a stable prescription of blood pressure lowering medication or non-steroidal anti-inflammatory drugs. for fewer than 2 months.
• Prescribed anti-coagulant/blood thinning medication (eg. warfarin).
• Taking flavonoid containing supplements (and unwilling to cease intake during, and 1 month preceding the trial) or unwilling to maintain existing intake of other supplements.
• High flavonoid intake defined as > 15 portions of flavonoid rich foods per day
• Are currently taking medication or supplements which have a significant impact on the outcome measures.

In addition, any participants with claustrophobia will not be invited to participate in the neuroimaging component of the study. Likewise for metal implants, e.g. pacemaker that precludes MRI.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

OTHER

Sponsor Role: collaborator

University of East Anglia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Vauzour, PhD

Role: PRINCIPAL_INVESTIGATOR

University of East Anglia

Michael Hornberger, PhD

Role: PRINCIPAL_INVESTIGATOR

University of East Anglia

Locations

University of East Anglia

Norwich, Norfolk, United Kingdom

Countries

United Kingdom

References

Flanagan E, Cameron D, Sobhan R, Wong C, Pontifex MG, Tosi N, Mena P, Del Rio D, Sami S, Narbad A, Muller M, Hornberger M, Vauzour D. Chronic Consumption of Cranberries (Vaccinium macrocarpon) for 12 Weeks Improves Episodic Memory and Regional Brain Perfusion in Healthy Older Adults: A Randomised, Placebo-Controlled, Parallel-Groups Feasibility Study. Front Nutr. 2022 May 19;9:849902. doi: 10.3389/fnut.2022.849902. eCollection 2022.

Reference Type: DERIVED

PMID: 35662954 (View on PubMed)

Other Identifiers

R204719

Identifier Type: -

Identifier Source: org_study_id