NCT03679533

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

The Impact of Cranberries on the Microbiome and the Brain in Healthy Ageing: A Feasibility Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of East Anglia · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Freeze-Dried Cranberry Powder	Freeze-dried cranberry powder (or matched placebo), approximating 500mg active flavonoids per day, taken twice daily for 12 weeks.
DIETARY_SUPPLEMENT	Placebo	Placebo food powder matched for taste, colour, energy and macronutrient content to the active cranberry powder.

Timeline

• Start date: 2018-10-02
• Primary completion: 2020-05-22
• Completion: 2020-05-22
• First posted: 2018-09-20
• Last updated: 2020-09-30

Locations

1 site across 1 country: United Kingdom