NCT04722549

Effects of Butyrate on Affective Processes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The effects of butyrate on psychobiological processes are examined in a sample of healthy volunteers.

Detailed description

The study is an interventional triple-blind, placebo-controlled, parallel group design with 2 arms (placebo, butyrate). Healthy male participants adhere to a low-fiber diet for the duration of the study (11 days). At the baseline study visit, measurements are taken in the lab, including biological samples and psychophysiological measurements. Participants then consume placebo or butyrate for 1 week and revisit the lab on day 11 for a second measurement of the outcomes of interest. Specifically, we investigate the effect of colonic butyrate administration on affective processing, including stress sensitivity and fear-related processes (e.g. extinction learning). Volunteers also respond to questionnaires in relation to mood and GI symptoms, and provide biological samples (saliva, blood, and faecal samples) for analysis of cortisol levels, circulating short chain fatty acids and serum BDNF, and faecal SCFA, respectively.

Conditions

• Emotions
• Stress
• Fear

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Cellulose
DIETARY_SUPPLEMENT	Butyrate	Sodium butyrate

Timeline

• Start date: 2021-02-08
• Primary completion: 2022-12-11
• Completion: 2022-12-11
• First posted: 2021-01-25
• Last updated: 2023-01-04

Locations

1 site across 1 country: Belgium