Recruiting

Chicory Inulin

Sponsor:

Purdue University

Code:

NCT06528041

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Inulin

Maltodextrin

Study Details

Brief summary:

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.

Conditions

Healthy

Study ID

NCT06528041

Start date

Aug 1, 2024

Status verified date

Dec, 2025

Completion date

Jul 30, 2026

Anticipated

Primary completion date

Jul 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Pure Inulin

12 g/day prebiotic supplement

placebo comparator: Placebo

6 g/day maltodextrin

Interventions

Inulin

12 g/day prebiotic supplement taken daily split into 2 dosages of 6 g dissolved in water

Maltodextrin

6 g/day maltodextrin taken daily split into 2 dosages of 3 g dissolved in water

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Stephen Lindemann, PhD

765-494-9207lindems@purdue.edu

Peter Jackson, PhD

7654099789ppjackso@purdue.edu

Locations

Purdue University

Recruiting

West Lafayette, Indiana, United States, 47907

Contacts

Stephen Lindemann, PhD

765-494-9207lindems@purdue.edu

Peter Jackson, PhD

765-509-9789ppjackso@purdue.edu

Principal Investigator:

Stepehen Lindemann, PhD

More Information

Sponsor

Purdue University

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Keywords

  • Gut microbiota
  • inulin
  • prebiotics
  • Bifidobacterium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Purdue University on 2025-12-11.