Clinical Trials Directory

Trials / Completed

CompletedNCT03688854

The Role of Short Chain Fatty Acids in Microbiota-gut-brain Axis

Effects of Short Chain Fatty Acids on Affective Processes in Humans

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
66 (actual)
Sponsor
KU Leuven · Academic / Other
Sex
Male
Age
20 Years – 40 Years
Healthy volunteers
Accepted

Summary

The role of short chain fatty acids (SCFA) in the microbiota-gut-brain axis is examined in a sample of healthy volunteers. SCFA are the major products of bacterial fermentation of dietary fiber in the colon, and are hypothesised to mediate the bidrectional communication between the gut and the residing microbiota on the one hand, and the central nervous system on the other hand. We perform a 1-week intervention with SCFA and measure their effects on a range of affective outcomes in healthy male volunteers.

Detailed description

The study is an interventional double-blind, placebo-controlled, parallel group design with 3 arms (placebo, high-dose of SCFA, and low-dose of SCFA). The high and low doses of SCFA are equivalent to 20 and 10 grams of fiber respectively. Healthy male participants follow a low-fiber diet for the study duration (11 days). On day 4, baseline measurements are taken in the lab, including biological samples and psychophysiological measurements. Participants then consume placebo or SCFA for one week and revisit the lab on day 11 for a second measurement of the outcomes of interest. Specifically, we investigate the effect of SCFA supplementation on affective processing, including stress sensitivity, fear-related processes (e.g. extinction learning), and attentional bias to emotional stimuli. Volunteers also respond to questionnaires in relation to mood, and provide biological samples (blood and faecal samples) for analysis of circulating short chain fatty acids and microbiota composition, respectively.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTSCFA mixtureIntracolonic administration

Timeline

Start date
2018-01-04
Primary completion
2018-09-15
Completion
2018-09-15
First posted
2018-09-28
Last updated
2018-10-02

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03688854. Inclusion in this directory is not an endorsement.