Gut Health, Inflammation, Hormones

NCT ID: NCT04267731

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2023-02-28

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.

Conditions

Aging Well

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Cellulose 0.75g per day

Group Type: PLACEBO_COMPARATOR

Cellulose

Intervention Type: DIETARY_SUPPLEMENT

Bulking agent in food production without probiotic properties

Low dose

0.25g VMK223 per day

Group Type: EXPERIMENTAL

VMK223

Intervention Type: DIETARY_SUPPLEMENT

Heat killed and purified Bifidobacterium breve polysaccharide-based extract

Middle dose

0.5g VMK223 per day

Group Type: EXPERIMENTAL

VMK223

Intervention Type: DIETARY_SUPPLEMENT

Heat killed and purified Bifidobacterium breve polysaccharide-based extract

High dose

0.75g VMK223 per day

Group Type: EXPERIMENTAL

VMK223

Intervention Type: DIETARY_SUPPLEMENT

Heat killed and purified Bifidobacterium breve polysaccharide-based extract

Interventions

VMK223

Heat killed and purified Bifidobacterium breve polysaccharide-based extract

Intervention Type: DIETARY_SUPPLEMENT

Cellulose

Bulking agent in food production without probiotic properties

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Bifidobacterium breve extract/lysate; Cellulose microcrystalline

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Roehampton

OTHER

Sponsor Role: collaborator

Vemico Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adele Costabile

Role: PRINCIPAL_INVESTIGATOR

University of Roehampton

Locations

University of Roehampton

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

VMK1

Identifier Type: -

Identifier Source: org_study_id