University of Roehampton
London, SW15 5PJ, United Kingdom
NCT Number: NCT04267731
Pilot exploratory study on the effect of a Bifidobacterium breve extract, as VMK223, on plasma inflammatory markers, saliva hormones, gut microbiota and tolerance in females over 50years old. Participants are randomised in one of 4 arms: 0.25g/d VMK223, 0.5g/d VMK223, 0.75g/d VMK223, or placebo.
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Notify Me50 year–65 year
Female
Interventional
Not applicable
London, SW15 5PJ, United Kingdom
The commensal bacteria colonising the gut and making up the microbiome perform a number of functions through their normal life cycle, which provide benefits to their human hosts in maintaining homeostasis. The relationship works both ways with the human host providing both nutrition and an environment for the bacteria to flourish.
Ageing is a natural and multifactorial phenomenon characterised by the accumulation of degenerative processes that are in turn underpinned by multiple alterations and damage within molecular pathways. The alterations and damage ultimately compromise cell and tissue functions. As such, ageing is the most profound risk factor for almost all non-communicable diseases. Amongst the key processes involved [in ageing], inflammation is of particular interest, because ageing is characterised by an increase in the concentration of a number of pro-inflammatory molecules in the circulation, a phenomenon that has been termed "inflammageing" and is a determinant of the speed of the ageing process and of lifespan.
Amongst the members of the human microbiome, Bifidobacterium spp. are resident microbiota members throughout the invesstigator's lifetime, with their levels across the life course aligning with key stages in immune maturation. Bifidobacteria influence this critical homeostatic development and programming by impacting on specific immune populations and signalling pathways associated with improved host well-being.
VMK223 is a heat treated Bifidobacterium breve extract, consisting of a low molecular weight storage polysaccharide that targets the reduction of NF-κB activation.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Heat killed and purified Bifidobacterium breve polysaccharide-based extract
Other names: Bifidobacterium breve extract/lysate
Bulking agent in food production without probiotic properties
Other names: Cellulose microcrystalline
Time frame: 3 weeks
self reported daily number of bowel movements
Time frame: 3 weeks
self reported daily using the bristol 7-point scale (1:hard to 7:watery)
Time frame: 3 weeks
self reported daily using a 4-point scale (0: none, 3: severe)
Time frame: 3 weeks
self reported daily using a 4-point scale (0: none, 3: severe)
Time frame: 3 weeks
self reported daily using a 4-point scale (0: none, 3: severe)
Time frame: 3 weeks
Plasma measurement
Time frame: 3 weeks
Plasma measurement
Time frame: 3 weeks
Plasma measurement
Time frame: 3 weeks
Plasma measurement
Time frame: 3 weeks
Plasma measurement
Time frame: 3 weeks
Plasma measurement
Time frame: 3 weeks
Saliva
Time frame: 3 weeks
saliva
Time frame: 3 weeks
saliva
Time frame: 3 weeks
Saliva
Time frame: 3 weeks
Saliva
Time frame: 1 day
Self reported positive/negative perception 5-point scale questionnaire. The positive affect score range is 10-50 and the negative affect score range is 10-50. Higher scores represent higher effect.
Vemico Ltd.
Industry
Double Blinded, Randomized, Placebo Controlled Preliminary Pilot Exploratory Investigation Into the Effects of a Bifidobacterium Breve Extract, as VMK223, on Blood Inflammatory Markers, Gut Microbiota Composition and Tolerance in Healthy Adults Ages >50yrs Over a 3-week Period
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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