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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | SCFA mixture | Intracolonic 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.