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Completed

NCT Number: NCT04267731

Gut Health, Inflammation, Hormones

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.

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Key information

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Roehampton

London, SW15 5PJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VMK223

Dietary Supplement

Heat killed and purified Bifidobacterium breve polysaccharide-based extract

Other names: Bifidobacterium breve extract/lysate

Cellulose

Dietary Supplement

Bulking agent in food production without probiotic properties

Other names: Cellulose microcrystalline

Primary outcomes

  1. Bowel Movements

    Time frame: 3 weeks

    self reported daily number of bowel movements

  2. Stool form

    Time frame: 3 weeks

    self reported daily using the bristol 7-point scale (1:hard to 7:watery)

  3. Flatulence

    Time frame: 3 weeks

    self reported daily using a 4-point scale (0: none, 3: severe)

  4. Bloating

    Time frame: 3 weeks

    self reported daily using a 4-point scale (0: none, 3: severe)

  5. Abdominal pain

    Time frame: 3 weeks

    self reported daily using a 4-point scale (0: none, 3: severe)

Secondary outcomes

  1. C-Reactive protein

    Time frame: 3 weeks

    Plasma measurement

  2. Interleukin-6

    Time frame: 3 weeks

    Plasma measurement

  3. Tumor Necrosis Factor alpha

    Time frame: 3 weeks

    Plasma measurement

  4. Interleukin-10

    Time frame: 3 weeks

    Plasma measurement

  5. Interferon gamma

    Time frame: 3 weeks

    Plasma measurement

  6. Human growth hormone

    Time frame: 3 weeks

    Plasma measurement

  7. Cortisol

    Time frame: 3 weeks

    Saliva

  8. Oestradiol

    Time frame: 3 weeks

    saliva

  9. Oestriol

    Time frame: 3 weeks

    saliva

  10. Progesterone

    Time frame: 3 weeks

    Saliva

  11. Dehydroepiandrosterone

    Time frame: 3 weeks

    Saliva

Other outcomes

  1. Positive and Negative Affect Schedule

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Vemico Ltd.

Industry

Collaborators

  • University of Roehampton

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2020
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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