NCT05254340

Healthy Volunteer Short Chain Fatty Acid Study

Terminated NA Results posted Last updated 25 September 2024

What this trial tests

NA trial testing Inulin in Healthy in 29 participants. Terminated before completion.

Timeline

1 August 2021

Primary endpoint
31 July 2023

31 July 2023

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	29
Start date	1 August 2021
Primary completion	31 July 2023
Estimated completion	31 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Inulin — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Indiana University

Who can join

Adults 18 to 75, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fecal Inulin Primary · 4 days

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

Group	Value	95% CI
Healthy Volunteers	45.2	34.6 – 58.6

Total Fecal Short Chain Fatty Acids Primary · 4 days

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

Group	Value	95% CI
Healthy Volunteers	207.4	159.7 – 375.5

Individual Fecal Short Chain Fatty Acids Primary · 4 days

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

Acetic Acid

Group	Value	95% CI
Healthy Volunteers	111.5	99.4 – 279.7

Priopionic Acid

Group	Value	95% CI
Healthy Volunteers	37.3	26.8 – 63.5

Butyric Acid

Group	Value	95% CI
Healthy Volunteers	51	25.1 – 60.3

Bowel Frequency Secondary · 4 days

Stool characteristics will be measured using a 4 day bowel diary (stool frequency, stool form, ease of passage). Bowel frequency indicates the total number of bowel movements in 4 days.

Group	Value	95% CI
Healthy Volunteers	4	4 – 4

Dietary Intake Secondary · 24 hours

Baseline dietary intake will be measured using an automated self-administered dietary assessment tool

Group	Value	95% CI
Healthy Volunteers	2065.9	1415.6 – 2666.1

Bowel Symptoms Secondary · 4 days

Stool characteristics will be measured using a 4 day bowel diary (stool frequency, stool form, ease of passage). Stool form is on a scale from 1 to 7, where 1=hard lumps, 2=lumps sausage, 3=cracked sausage, 4=normal, 5=soft lumps, 6=mushy, 7=watery, summarized on the level of bowel movements. Ease of passage is on a scale from 1 to 7, where 1=manual disimpaction, 2=enema needed, 3=straining needed, 4=normal, 5=urgent without pain, 6=urgent with pain, 7=incontinent, also summarized on the level of bowel movements.

Stool form

Group	Value	95% CI
Healthy Volunteers	4	3 – 5

Ease of passage

Group	Value	95% CI
Healthy Volunteers	4	4 – 4

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.