The Impact of Cranberries On the Microbiome and the Brain in Healthy Ageing sTudy (COMBAT) (COMBAT)
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|ClinicalTrials.gov Identifier: NCT03679533|
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : January 24, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Aging Cognitive Decline||Dietary Supplement: Freeze-Dried Cranberry Powder Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind placebo-controlled parallel intervention|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Impact of Cranberries on the Microbiome and the Brain in Healthy Ageing: A Feasibility Intervention|
|Actual Study Start Date :||October 2, 2018|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
|Active Comparator: Active Cranberry Study Food||
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.
|Placebo Comparator: Placebo Study Food||
Dietary Supplement: Placebo
Placebo food powder matched for taste, colour, energy and macronutrient content to the active cranberry powder.
- Gut microflora speciation and metabolism [ Time Frame: 12 weeks ]Measured in faecal and serum samples.
- Change in volumes of hippocampus and other key brain structures [ Time Frame: 12 weeks ]Structural magnetic resonance imaging
- Change in cerebrovascular blood flow [ Time Frame: 12 weeks ]Measured using spectroscopy
- Change in global cognition [ Time Frame: 12 weeks ]Global cognition to be measured using the Addenbrooke's Cognitive Examination - III, from 0-100, with higher scores indicating better global cognitive performance.
- Change in spatial navigation abilities [ Time Frame: 12 weeks ]The Supermarket Test, with outcomes including accurate reporting of starting direction, and accurate indication of end position and direction.
- Change in executive function and attention [ Time Frame: 12 weeks ]Trail Making Test, with scores including time taken to complete and number of errors made.
- Change in memory performance [ Time Frame: 12 weeks ]The Rey Complex Figure Test, with outcomes including time taken to complete copy, accuracy out of a possible 36 of copy and accuracy out of 36 of 3-minute recall.
- Change in spatial navigation abilities [ Time Frame: 12 weeks ]SeaHero Quest Test, with outcomes including time taken to complete, accuracy of path taken and number of errors made.
- Change in executive function and attention [ Time Frame: 12 Weeks ]Digit Span Backwards, scored out of a possible 14 for numbers recited backwards in the correct order.
- Change in presence of circulating inflammatory biomarkers (hs-CRP) [ Time Frame: 12 weeks ]Blood samples analysed for presence of inflammatory cytokines
- Change in circulating biomarkers of neuronal functioning and cognitive decline (BDNF) [ Time Frame: 12 weeks ]Blood samples analysed for presence of circulating biomarkers of neural function
- Change in circulating biomarkers of lipid metabolism (total-, HDL-, LDL-cholesterol) [ Time Frame: 12 weeks ]Blood samples analysed for presence of circulating biomarkers of lipid metabolism
- Change in circulating biomarkers of lipid metabolism (triglycerides) [ Time Frame: 12 weeks ]Blood samples analysed for presence of circulating biomarkers of lipid metabolism
- Changes in energy expenditure and sleep [ Time Frame: 12 weeks ]Actigraphs to be used to measure changes in activity and sleep patterns of participants.
- Genetics related to neurodegenerative disease [ Time Frame: Baseline ]Blood samples to be analysed for genes associated with neurodegenerative disease and dementia (eg. C9ORF72, APOE-4)
- Biomarkers of gut permability and endotoxemia (LPS) [ Time Frame: 12 weeks ]Blood serum/plasma samples to be analysed for presence of lipopolysaccharide (LPS) as a biomarker of gut permability and possible endotoxemia
- Levels of sunlight exposure [ Time Frame: Baseline, Follow-up ]Self-reported levels of daily sunlight exposure to be measured using a brief questionnaire
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): NCT03679533
|Contact: Emma Flanagan, BSc||+44 firstname.lastname@example.org|
|Contact: David Vauzour, PhDemail@example.com|
|University of East Anglia||Recruiting|
|Norwich, Norfolk, United Kingdom, NR4 7UQ|
|Contact: Emma Flanagan, BSc +4401603591623 firstname.lastname@example.org|
|Principal Investigator:||David Vauzour, PhD||University of East Anglia|
|Principal Investigator:||Michael Hornberger, PhD||University of East Anglia|