Gut Health, Inflammation, Hormones

Aging Well Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04267731
• Other study ID #: VMK1
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2022
• Source: Vemico Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging Well
• Inflammation

Intervention

Dietary Supplement:
• VMK223
Heat killed and purified Bifidobacterium breve polysaccharide-based extract
• Cellulose
Bulking agent in food production without probiotic properties

Locations

Country	Name	City	State
United Kingdom	University of Roehampton	London

Sponsors (2)

Lead Sponsor	Collaborator
Vemico Ltd.	University of Roehampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Positive and Negative Affect Schedule	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.	1 day
Primary	Bowel Movements	self reported daily number of bowel movements	3 weeks
Primary	Stool form	self reported daily using the bristol 7-point scale (1:hard to 7:watery)	3 weeks
Primary	Flatulence	self reported daily using a 4-point scale (0: none, 3: severe)	3 weeks
Primary	Bloating	self reported daily using a 4-point scale (0: none, 3: severe)	3 weeks
Primary	Abdominal pain	self reported daily using a 4-point scale (0: none, 3: severe)	3 weeks
Secondary	C-Reactive protein	Plasma measurement	3 weeks
Secondary	Interleukin-6	Plasma measurement	3 weeks
Secondary	Tumor Necrosis Factor alpha	Plasma measurement	3 weeks
Secondary	Interleukin-10	Plasma measurement	3 weeks
Secondary	Interferon gamma	Plasma measurement	3 weeks
Secondary	Human growth hormone	Plasma measurement	3 weeks
Secondary	Cortisol	Saliva	3 weeks
Secondary	Oestradiol	saliva	3 weeks
Secondary	Oestriol	saliva	3 weeks
Secondary	Progesterone	Saliva	3 weeks
Secondary	Dehydroepiandrosterone	Saliva	3 weeks