Clinical trial NCT04267731: Gut Health, Inflammation, Hormones
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Well
Keywords: Gut microbiota
Postbiotics
Inflammation
Lead sponsor: Vemico Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of Roehampton
First posted: 2020-02-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded, placebo controlled, randomised dose response study
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults, aged 50 years to 65 years
* Not dieting within the last month and not having lost \>5% body weight in the previous year
* Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study
* Understands and is willing, able and likely to comply with all study procedures and restriction including being willing to follow the nutritional advice
* Able to eat most everyday foods
* Habitually consumes three standard meals a day

Exclusion Criteria:

* Significant health problems (e.g. hypercholesterolaemia, diabetes, GI disorders)
* Taking any medication or supplements known to affect immune system function within the past month and/or during the study
* Pregnant, planning to become pregnant or breastfeeding
* History of anaphylaxis to food
* Known allergies or intolerance to foods and/or to the study materials (or closely related compounds) or any of their stated ingredients
* Volunteers self-reporting currently dieting or having lost \>5% body weight in the previous year
* Participants with abnormal eating behaviour
* Participation in another experimental study or receipt of an investigational drug/product within 30 days of the screening visit
* Volunteers who have significantly changed their physical activity in the past 2-4 weeks or who intend to change them during the study
* Participants receiving systemic or local treatment likely to interfere with the evaluation of the study parameters
* Participants on specific food avoidance diets
* Participants who work in appetite or feeding related areas

Primary outcomes:
measure: Bowel Movements
timeFrame: 3 weeks
measure: Stool form
timeFrame: 3 weeks
measure: Flatulence
timeFrame: 3 weeks
measure: Bloating
timeFrame: 3 weeks
measure: Abdominal pain
timeFrame: 3 weeks
Secondary outcomes:
measure: C-Reactive protein
timeFrame: 3 weeks
measure: Interleukin-6
timeFrame: 3 weeks
measure: Tumor Necrosis Factor alpha
timeFrame: 3 weeks
measure: Interleukin-10
timeFrame: 3 weeks
measure: Interferon gamma
timeFrame: 3 weeks
measure: Human growth hormone
timeFrame: 3 weeks
measure: Cortisol
timeFrame: 3 weeks
measure: Oestradiol
timeFrame: 3 weeks
measure: Oestriol
timeFrame: 3 weeks
measure: Progesterone
timeFrame: 3 weeks
measure: Dehydroepiandrosterone
timeFrame: 3 weeks
Other outcomes:
measure: Positive and Negative Affect Schedule
timeFrame: 1 day
Locations:
city: London
country: United Kingdom
facility: University of Roehampton
Study officials:
affiliation: University of Roehampton
name: Adele Costabile
role: PRINCIPAL_INVESTIGATOR
References: