NCT04267731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2022

Enrollment Period

3.2 years

First QC Date

February 6, 2020

Last Update Submit

April 25, 2023

Conditions

Aging Well

Keywords

Gut microbiotaPostbioticsInflammation

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (11)

  • C-Reactive protein

    3 weeks

  • Interleukin-6

    3 weeks

  • Tumor Necrosis Factor alpha

    3 weeks

  • Interleukin-10

    3 weeks

  • Interferon gamma

    3 weeks

  • +6 more secondary outcomes

Other Outcomes (1)

  • Positive and Negative Affect Schedule

    1 day

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Cellulose 0.75g per day

Dietary Supplement: Cellulose

Low dose

EXPERIMENTAL

0.25g VMK223 per day

Dietary Supplement: VMK223

Middle dose

EXPERIMENTAL

0.5g VMK223 per day

Dietary Supplement: VMK223

High dose

EXPERIMENTAL

0.75g VMK223 per day

Dietary Supplement: VMK223

Interventions

VMK223DIETARY_SUPPLEMENT

Heat killed and purified Bifidobacterium breve polysaccharide-based extract

Also known as: Bifidobacterium breve extract/lysate
High doseLow doseMiddle dose
CelluloseDIETARY_SUPPLEMENT

Bulking agent in food production without probiotic properties

Also known as: Cellulose microcrystalline
Placebo

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Roehampton

London, SW15 5PJ, United Kingdom

Location

MeSH Terms

Conditions

Inflammation

Interventions

Cellulosemicrocrystalline cellulose

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Adele Costabile

    University of Roehampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double blinded, placebo controlled, randomised dose response study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 13, 2020

Study Start

December 1, 2019

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

April 26, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

De-identified participants data for all outcomes will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
3 months after study completion
Access Criteria
Based on a data sharing agreement, a review panel will decide on all data sharing request

Locations

GB(1)