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

Purdue University · NCT06528041

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
52
US sites recruiting
1
Study start
August 1, 2024
Record last updated
December 11, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Inulin; Maltodextrin

Conditions: Healthy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • adults aged 18-45
  • BMI >18.5 - \< 30 kg/m2
  • Regular bowel movements (> 4 days per week)

Exclusion Criteria

  • Self-reported sensitivity to FODMAPs and following a low FODMAP diet ((FODMAPS stands for fermentable oligosaccharides, disaccharides, monosaccharides and polyols).
  • Self-reported food allergies and sensitivities including gluten, dairy, nuts, soya and lactose etc.
  • Self-reported antibiotic treatment in the past 6 months.
  • Self-reported history of gastrointestinal disease and/or heart disease, cardiovascular, liver, and respiratory disorders, cancer and/or clinically relevant (pre) diabetes.
  • Self-reported to having undergone major surgery of the gastrointestinal tract, with the exception of cholecystectomy and appendectomy.
  • Self-reported smoking and/or self-reported drug or alcohol abuse.
  • Self-reported history of psychiatric and/or mood disorders including eating disorders.
  • Self-reported to be following a restrictive diet (i.e. ketogenic, intermittent fasting).
  • Pregnant and lactating women.

Recruiting US locations

  • Purdue University

    West Lafayette, IN 47907

    Site contact: Stephen Lindemann, PhD · 765-494-9207 · lindems@purdue.edu

Study contacts (from the official record)

  • Stephen Lindemann, PhD · 765-494-9207 · lindems@purdue.edu
  • Peter Jackson, PhD · 7654099789 · ppjackso@purdue.edu
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