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

NCT06528041 | Recruiting

• 1 other identifier: IRB-2024-154
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

Gut microbiota; inulin; prebiotics; Bifidobacterium

Outcome Measures

Primary Outcomes (1)

• Changes in Bifidobacterium counts in stool samples

  Bifidobacterium counts will be assessed by fluorescence in situ hybridisation - flow cytometry (FISH-FLOW) and 16S rRNA gene sequencing

  13 weeks

Secondary Outcomes (21)

• Total bacteria in stool samples

  13 weeks

• Changes in gut bacterial composition

  13 weeks

• Changes in gut fermentation kinetics

  10 days over 13 weeks

• Changes in short-chain fatty acid production

  10 times over 13 weeks

• Stool frequency

  13 week

Study Arms (2)

Pure Inulin

EXPERIMENTAL

12 g/day prebiotic supplement

Other: Inulin

Placebo

PLACEBO COMPARATOR

6 g/day maltodextrin

Other: Maltodextrin

Interventions

Inulin OTHER

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

Pure Inulin

Maltodextrin OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

RECRUITING

MeSH Terms

Interventions

Inulin; maltodextrin

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Stephen Lindemann, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Lindemann, PhD

CONTACT

765-494-9207; lindems@purdue.edu

Peter Jackson, PhD

CONTACT

7654099789; ppjackso@purdue.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 13 week, 2 arm parallel, double blind, randomised, placebo-controlled trial

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)