RECRUITING

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

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Conditions

HealthyGut microbiotainulinprebioticsBifidobacterium

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Native Chicory Inulin Supplementation on Rates of Microbial Change Between Individuals

Quick Facts

Study Start:2024-08-01
Study Completion:2026-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06528041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * adults aged 18-45
  2. * BMI \>18.5 - \< 30 kg/m2
  3. * Regular bowel movements (\> 4 days per week)
  1. * Self-reported sensitivity to FODMAPs and following a low FODMAP diet ((FODMAPS stands for fermentable oligosaccharides, disaccharides, monosaccharides and polyols).
  2. * Self-reported food allergies and sensitivities including gluten, dairy, nuts, soya and lactose etc.
  3. * Self-reported antibiotic treatment in the past 6 months.
  4. * Self-reported history of gastrointestinal disease and/or heart disease, cardiovascular, liver, and respiratory disorders, cancer and/or clinically relevant (pre) diabetes.
  5. * Self-reported to having undergone major surgery of the gastrointestinal tract, with the exception of cholecystectomy and appendectomy.
  6. * Self-reported smoking and/or self-reported drug or alcohol abuse.
  7. * Self-reported history of psychiatric and/or mood disorders including eating disorders.
  8. * Self-reported to be following a restrictive diet (i.e. ketogenic, intermittent fasting).
  9. * Pregnant and lactating women.

Contacts and Locations

Study Contact

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

Principal Investigator

Stephen Lindemann, PhD
PRINCIPAL_INVESTIGATOR
Purdue University

Study Locations (Sites)

Purdue University
West Lafayette, Indiana, 47907
United States

Collaborators and Investigators

Sponsor: Purdue University

  • Stephen Lindemann, PhD, PRINCIPAL_INVESTIGATOR, Purdue University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2026-08-30

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2026-08-30

Terms related to this study

Keywords Provided by Researchers

  • Gut microbiota
  • inulin
  • prebiotics
  • Bifidobacterium

Additional Relevant MeSH Terms

  • Healthy