Aging WellNCT04267731
Gut Health, Inflammation, Hormones
A study testing VMK223 and Cellulose in people with Aging Well, run by Vemico Ltd. at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging Well
- What is being tested?
- VMK223 and Cellulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2019to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- VMK223, Cellulose
- Keywords
- Gut microbiota, Postbiotics, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMK223Dietary supplement
Also called Bifidobacterium breve extract/lysate
Heat killed and purified Bifidobacterium breve polysaccharide-based extract
CelluloseDietary supplement
Also called Cellulose microcrystalline
Bulking agent in food production without probiotic properties
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Cellulose 0.75g per day Receives: Dietary Supplement: Cellulose |
| Low dose | Experimental | 0.25g VMK223 per day Receives: Dietary Supplement: VMK223 |
| Middle dose | Experimental | 0.5g VMK223 per day Receives: Dietary Supplement: VMK223 |
| High dose | Experimental | 0.75g VMK223 per day Receives: Dietary Supplement: VMK223 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Movements
self reported daily number of bowel movements
Measured: 3 weeks
Stool form
self reported daily using the bristol 7-point scale (1:hard to 7:watery)
Measured: 3 weeks
Flatulence
self reported daily using a 4-point scale (0: none, 3: severe)
Measured: 3 weeks
Bloating
self reported daily using a 4-point scale (0: none, 3: severe)
Measured: 3 weeks
Abdominal pain
self reported daily using a 4-point scale (0: none, 3: severe)
Measured: 3 weeks
Secondary outcomes (11)
C-Reactive protein
Plasma measurement
Measured: 3 weeks
Interleukin-6
Plasma measurement
Measured: 3 weeks
Tumor Necrosis Factor alpha
Plasma measurement
Measured: 3 weeks
Interleukin-10
Plasma measurement
Measured: 3 weeks
Interferon gamma
Plasma measurement
Measured: 3 weeks
Human growth hormone
Plasma measurement
Measured: 3 weeks
Cortisol
Saliva
Measured: 3 weeks
Oestradiol
saliva
Measured: 3 weeks
Oestriol
saliva
Measured: 3 weeks
Progesterone
Saliva
Measured: 3 weeks
Dehydroepiandrosterone
Saliva
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Dec 2019
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aging WellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, placebo controlled, randomised dose response study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vemico Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Roehampton
- Responsible party
- Sponsor
- Investigators
- Adele Costabile, Principal investigator, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267731
- Sponsor's protocol ID
- VMK1
- Status last verified
- Apr 2022
- First submitted
- 6 Feb 2020
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participants data for all outcomes will be made available.
Publications
Pipino C, Costabile F, Pelaez SM, Tzortzis G, Vulevic J, Costabile A. Oral Postbiotic (VMK223) Supplementation Is Associated with Improved Instrumental Skin Appearance Parameters in Healthy Women Aged 40-55 Years: A Randomized, Double-Blind, Placebo-Controlled Trial. Dermatol Ther (Heidelb). 2026 Jun;16(6):3107-3121. doi: 10.1007/s13555-026-01754-6. Epub 2026 May 3.
PubMed 42070198
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04267731
- Acronym / sponsor ID
- VMK1
- Conditions
- Aging Well
- Keywords
- Gut microbiota, Postbiotics, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vemico Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Roehampton
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double blinded, placebo controlled, randomised dose response study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: CelluloseCellulose 0.75g per day |
| Low dose | Experimental | Dietary Supplement: VMK2230.25g VMK223 per day |
| Middle dose | Experimental | Dietary Supplement: VMK2230.5g VMK223 per day |
| High dose | Experimental | Dietary Supplement: VMK2230.75g VMK223 per day |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VMK223Also: Bifidobacterium breve extract/lysateHeat killed and purified Bifidobacterium breve polysaccharide-based extract | Dietary supplement | High dose, Low dose, Middle dose |
| CelluloseAlso: Cellulose microcrystallineBulking agent in food production without probiotic properties | Dietary supplement | Placebo |
Primary outcome
Bowel Movements
Time frame: 3 weeks
self reported daily number of bowel movements
Stool form
Time frame: 3 weeks
self reported daily using the bristol 7-point scale (1:hard to 7:watery)
Flatulence
Time frame: 3 weeks
self reported daily using a 4-point scale (0: none, 3: severe)
Bloating
Time frame: 3 weeks
self reported daily using a 4-point scale (0: none, 3: severe)
Abdominal pain
Time frame: 3 weeks
self reported daily using a 4-point scale (0: none, 3: severe)
11 secondary outcomes
C-Reactive protein
Time frame: 3 weeks
Interleukin-6
Time frame: 3 weeks
Tumor Necrosis Factor alpha
Time frame: 3 weeks
Interleukin-10
Time frame: 3 weeks
Interferon gamma
Time frame: 3 weeks
Human growth hormone
Time frame: 3 weeks
Cortisol
Time frame: 3 weeks
Oestradiol
Time frame: 3 weeks
Oestriol
Time frame: 3 weeks
Progesterone
Time frame: 3 weeks
Dehydroepiandrosterone
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Derived from this study: PubMed 42070198Pipino C, Costabile F, Pelaez SM, Tzortzis G, Vulevic J, Costabile A. Oral Postbiotic (VMK223) Supplementation Is Associated with Improved Instrumental Skin Appearance Parameters in Healthy Women Aged 40-55 Years: A Randomized, Double-Blind, Placebo-Controlled Trial. Dermatol Ther (Heidelb). 2026 Jun;16(6):3107-3121. doi: 10.1007/s13555-026-01754-6. Epub 2026 May 3.
- Individual participant dataSharing planned: Yes. De-identified participants data for all outcomes will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adele Costabile principal investigator
University of Roehampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VMK223 and Cellulose in people with Aging Well, run by Vemico Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Movements (time frame: 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04267731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.