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Gut Health, Inflammation, Hormones

NCT04267731 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-26

No results posted yet for this study

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.

Conditions

  • Aging Well

Interventions

DIETARY_SUPPLEMENT

VMK223

Heat killed and purified Bifidobacterium breve polysaccharide-based extract

DIETARY_SUPPLEMENT

Cellulose

Bulking agent in food production without probiotic properties

Sponsors & Collaborators

  • University of Roehampton

    collaborator OTHER

  • Vemico Ltd.

    lead INDUSTRY

Principal Investigators

  • Adele Costabile · University of Roehampton

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04267731 on ClinicalTrials.gov