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Gut Health, Inflammation, Hormones

Primary Purpose

Aging Well

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
VMK223
Cellulose
Sponsored by
Vemico Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging Well focused on measuring Gut microbiota, Postbiotics, Inflammation

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Roehampton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Low dose

Middle dose

High dose

Arm Description

Cellulose 0.75g per day

0.25g VMK223 per day

0.5g VMK223 per day

0.75g VMK223 per day

Outcomes

Primary Outcome Measures

Bowel Movements
self reported daily number of bowel movements
Stool form
self reported daily using the bristol 7-point scale (1:hard to 7:watery)
Flatulence
self reported daily using a 4-point scale (0: none, 3: severe)
Bloating
self reported daily using a 4-point scale (0: none, 3: severe)
Abdominal pain
self reported daily using a 4-point scale (0: none, 3: severe)

Secondary Outcome Measures

C-Reactive protein
Plasma measurement
Interleukin-6
Plasma measurement
Tumor Necrosis Factor alpha
Plasma measurement
Interleukin-10
Plasma measurement
Interferon gamma
Plasma measurement
Human growth hormone
Plasma measurement
Cortisol
Saliva
Oestradiol
saliva
Oestriol
saliva
Progesterone
Saliva
Dehydroepiandrosterone
Saliva

Full Information

First Posted
February 6, 2020
Last Updated
April 25, 2023
Sponsor
Vemico Ltd.
Collaborators
University of Roehampton
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1. Study Identification

Unique Protocol Identification Number
NCT04267731
Brief Title
Gut Health, Inflammation, Hormones
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vemico Ltd.
Collaborators
University of Roehampton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging Well
Keywords
Gut microbiota, Postbiotics, Inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded, placebo controlled, randomised dose response study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Cellulose 0.75g per day
Arm Title
Low dose
Arm Type
Experimental
Arm Description
0.25g VMK223 per day
Arm Title
Middle dose
Arm Type
Experimental
Arm Description
0.5g VMK223 per day
Arm Title
High dose
Arm Type
Experimental
Arm Description
0.75g VMK223 per day
Intervention Type
Dietary Supplement
Intervention Name(s)
VMK223
Other Intervention Name(s)
Bifidobacterium breve extract/lysate
Intervention Description
Heat killed and purified Bifidobacterium breve polysaccharide-based extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Cellulose
Other Intervention Name(s)
Cellulose microcrystalline
Intervention Description
Bulking agent in food production without probiotic properties
Primary Outcome Measure Information:
Title
Bowel Movements
Description
self reported daily number of bowel movements
Time Frame
3 weeks
Title
Stool form
Description
self reported daily using the bristol 7-point scale (1:hard to 7:watery)
Time Frame
3 weeks
Title
Flatulence
Description
self reported daily using a 4-point scale (0: none, 3: severe)
Time Frame
3 weeks
Title
Bloating
Description
self reported daily using a 4-point scale (0: none, 3: severe)
Time Frame
3 weeks
Title
Abdominal pain
Description
self reported daily using a 4-point scale (0: none, 3: severe)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
C-Reactive protein
Description
Plasma measurement
Time Frame
3 weeks
Title
Interleukin-6
Description
Plasma measurement
Time Frame
3 weeks
Title
Tumor Necrosis Factor alpha
Description
Plasma measurement
Time Frame
3 weeks
Title
Interleukin-10
Description
Plasma measurement
Time Frame
3 weeks
Title
Interferon gamma
Description
Plasma measurement
Time Frame
3 weeks
Title
Human growth hormone
Description
Plasma measurement
Time Frame
3 weeks
Title
Cortisol
Description
Saliva
Time Frame
3 weeks
Title
Oestradiol
Description
saliva
Time Frame
3 weeks
Title
Oestriol
Description
saliva
Time Frame
3 weeks
Title
Progesterone
Description
Saliva
Time Frame
3 weeks
Title
Dehydroepiandrosterone
Description
Saliva
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
Positive and Negative Affect Schedule
Description
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.
Time Frame
1 day

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adele Costabile
Organizational Affiliation
University of Roehampton
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Roehampton
City
London
ZIP/Postal Code
SW15 5PJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Gut Health, Inflammation, Hormones

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