Gut Health, Inflammation, Hormones

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Aging Well

Intervention / Treatment
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* Dietary Supplement: VMK223
* Dietary Supplement: Cellulose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded, placebo controlled, randomised dose response study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Cellulose 0.75g per day | Dietary Supplement: Cellulose<br>* Bulking agent in food production without probiotic properties<br>* Other names: Cellulose microcrystalline;|
| Experimental: Low dose<br>0.25g VMK223 per day | Dietary Supplement: VMK223<br>* Heat killed and purified Bifidobacterium breve polysaccharide-based extract<br>* Other names: Bifidobacterium breve extract/lysate;|
| Experimental: Middle dose<br>0.5g VMK223 per day | Dietary Supplement: VMK223<br>* Heat killed and purified Bifidobacterium breve polysaccharide-based extract<br>* Other names: Bifidobacterium breve extract/lysate;|
| Experimental: High dose<br>0.75g VMK223 per day | Dietary Supplement: VMK223<br>* Heat killed and purified Bifidobacterium breve polysaccharide-based extract<br>* Other names: Bifidobacterium breve extract/lysate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel Movements | self reported daily number of bowel movements | 3 weeks | 
| Stool form | self reported daily using the bristol 7-point scale (1:hard to 7:watery) | 3 weeks | 
| Flatulence | self reported daily using a 4-point scale (0: none, 3: severe) | 3 weeks | 
| Bloating | self reported daily using a 4-point scale (0: none, 3: severe) | 3 weeks | 
| Abdominal pain | self reported daily using a 4-point scale (0: none, 3: severe) | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-Reactive protein | Plasma measurement | 3 weeks | 
| Interleukin-6 | Plasma measurement | 3 weeks | 
| Tumor Necrosis Factor alpha | Plasma measurement | 3 weeks | 
| Interleukin-10 | Plasma measurement | 3 weeks | 
| Interferon gamma | Plasma measurement | 3 weeks | 
| Human growth hormone | Plasma measurement | 3 weeks | 
| Cortisol | Saliva | 3 weeks | 
| Oestradiol | saliva | 3 weeks | 
| Oestriol | saliva | 3 weeks | 
| Progesterone | Saliva | 3 weeks | 
| Dehydroepiandrosterone | Saliva | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut microbiota, Postbiotics, Inflammation