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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
30
University of Roehampton
London, United Kingdom
Bowel Movements
self reported daily number of bowel movements
Time frame: 3 weeks
Stool form
self reported daily using the bristol 7-point scale (1:hard to 7:watery)
Time frame: 3 weeks
Flatulence
self reported daily using a 4-point scale (0: none, 3: severe)
Time frame: 3 weeks
Bloating
self reported daily using a 4-point scale (0: none, 3: severe)
Time frame: 3 weeks
Abdominal pain
self reported daily using a 4-point scale (0: none, 3: severe)
Time frame: 3 weeks
C-Reactive protein
Plasma measurement
Time frame: 3 weeks
Interleukin-6
Plasma measurement
Time frame: 3 weeks
Tumor Necrosis Factor alpha
Plasma measurement
Time frame: 3 weeks
Interleukin-10
Plasma measurement
Time frame: 3 weeks
Interferon gamma
Plasma measurement
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Time frame: 3 weeks
Human growth hormone
Plasma measurement
Time frame: 3 weeks
Cortisol
Saliva
Time frame: 3 weeks
Oestradiol
saliva
Time frame: 3 weeks
Oestriol
saliva
Time frame: 3 weeks
Progesterone
Saliva
Time frame: 3 weeks
Dehydroepiandrosterone
Saliva
Time frame: 3 weeks