NCT05254340

Brief Summary

The purpose of this study is to evaluate the production of short chain fatty acids (fatty acids are part of your diet) in stool through the measurement of fecal inulin after a one-time ingestion of 10-gram dose of inulin among healthy adult volunteers.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 25, 2024

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

October 7, 2021

Results QC Date

July 18, 2024

Last Update Submit

September 19, 2024

Conditions

Healthy

Keywords

bile acidinulinmicrobiota

Outcome Measures

Primary Outcomes (3)

  • Fecal Inulin

    Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography

    4 days

  • Total Fecal Short Chain Fatty Acids

    Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry

    4 days

  • Individual Fecal Short Chain Fatty Acids

    Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry

    4 days

Secondary Outcomes (3)

  • Bowel Frequency

    4 days

  • Dietary Intake

    24 hours

  • Bowel Symptoms

    4 days

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

Adults ages 18-75 years with no prior history of gastrointestinal diseases or symptoms.

Dietary Supplement: Inulin

Interventions

InulinDIETARY_SUPPLEMENT

Inulin ingestion is not being used to diagnose, treat, or prevent irritable bowel syndrome. Inulin is being used to study an individual's ability to ferment dietary fiber.

Healthy volunteers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults ages 18-75 years with no prior history of GI disease or symptoms.
  • Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low fermentable oligo-, di-, monosaccharides, and polyols diet (FODMAP) diet at the time of study participation

You may not qualify if:

  • History of microscopic colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated aspartate transaminase/alanine transaminase \> 2.0x the upper limit of normal
  • Prior therapy of the abdomen or abdominal surgeries with the exception of appendectomy or cholecystectomy \> 6 months prior to study initiation
  • Ingestion of any prescription, over the counter, or herbal medications which can affect study interpretation within 6 months of study initiation for asymptomatic volunteers. Rescue therapy to facilitate stool collection will be permitted where needed.
  • Any females who are pregnant or breast-feeding
  • Antibiotic usage within 3 months prior to study participation
  • Prebiotic or probiotic usage within the 2 weeks prior to study initiation
  • Inulin usage within the 2 weeks prior to study initiation
  • Use of tobacco products within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Inulin

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Results Point of Contact

Title
Dr. Huiping Xu
Organization
Indiana University
huipxu@iu.edu
317-278-6735

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 7, 2021

First Posted

February 24, 2022

Study Start

August 1, 2021

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

September 25, 2024

Results First Posted

September 25, 2024

Record last verified: 2024-09

Locations

US(1)