Gut Health, Inflammation, Hormones

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

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.

Study Overview

• Status: Completed
• Conditions: Aging Well
• Intervention / Treatment: Dietary supplement: Cellulose; Dietary supplement: VMK223

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW15 5PJ
    • University of Roehampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vemico Ltd.
• Collaborators: University of Roehampton
• Investigators: Principal Investigator: Adele Costabile, University of Roehampton

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Inflammation; Gut microbiota; Postbiotics
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: VMK1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participants data for all outcomes will be made available.
• IPD Sharing Time Frame: 3 months after study completion
• IPD Sharing Access Criteria: Based on a data sharing agreement, a review panel will decide on all data sharing request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No