Impact of Native Chicory Inulin on Change and Persistence of Gut Microbiota

Part of paid clinical trials in West Lafayette, Indiana.

Sponsor
Purdue University
Study ID
NCT06528041
Status
Recruiting
Apply to this trial

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Inulin — OTHER
    12 g/day prebiotic supplement taken daily split into 2 dosages of 6 g dissolved in water
  • Maltodextrin — OTHER
    6 g/day maltodextrin taken daily split into 2 dosages of 3 g dissolved in water

Study Details

The main aim of this study is to investigate differences in rate, extent of change and persistence of the gut microbiota in healthy adult volunteers in response to native chicory inulin. Along with investigating the impact of native chicory on bowl habits, mood and appetite. The two main questions this study aims to answer: * To what extent do differences exist in rate of change over time between individuals in gut microbiota response (Bifidobacterium growth) to native chicory inulin supplementation. * To what extent do differences exist between individuals in persistence of the gut microbiota upon stopping supplementation. The effects of native chicory inulin on gut microbiota response will be compared to a maltodextrin placebo to sure changes in gut microbiota result directly from chicory inulin supplementation. Participants will firstly complete a one-week run-in phase to establish baseline data and will then be allocated to either native chicory inulin or maltodextrin supplementation for 6 weeks. Inulin will be delivered at 12 g/day split into 2 x 6g portions. Maltodextrin will be calorie matched at 6 g/day split into 2 x 3g portions. This will then be followed by a 6 week post-supplementation phase. Fecal and blood samples will be collected regularly throughout all phases for analysis of gut microbiota and compounds of interest. Participants will also record any changes in gastrointestinal sensation, bowel habits and mood in a diary. Changes in appetite sensation will also measured.

Key Dates

Start date
Aug 1, 2024
Status verified
Dec 2025
Primary completion
Jul 28, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Pure Inulin
    12 g/day prebiotic supplement
  • Placebo Comparator: Placebo
    6 g/day maltodextrin

Primary Outcome Measure

Changes in Bifidobacterium counts in stool samples [ Time Frame: 13 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Purdue UniversityWest LafayetteIndiana47907
Stephen Lindemann, PhD
[email protected]
765-494-9207
Peter Jackson, PhD
[email protected]
765-509-9789
Stepehen Lindemann, PhD (PRINCIPAL_INVESTIGATOR)
Peter Jackson, PhD (SUB_INVESTIGATOR)
Richard Mattes, Prof (SUB_INVESTIGATOR)

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Purdue University· West Lafayette, IN

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