NCT04522258

Effects of Dietary Fiber on Affective Processes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The effects of dietary fiber 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, dietary fiber). Healthy male participants adhere to their normal eating habits for the duration of the study (32 days). At the baseline study visit, measurements are taken in the lab, including biological samples and psychophysiological measurements. Participants then consume placebo or dietary fiber for 4 weeks and revisit the lab on day 32 for a second measurement of the outcomes of interest. Specifically, we investigate the effect of dietary fiber 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, faecal, and urine samples) for analysis of cortisol levels, circulating short chain fatty acids and serum BDNF, faecal SCFA and microbiota composition, and intestinal permeability, respectively.

Conditions

• Emotions
• Stress
• Fear

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary fiber	Fermentable cereal bran
DIETARY_SUPPLEMENT	Placebo	Refined cereal flour

Timeline

• Start date: 2019-05-02
• Primary completion: 2020-11-08
• Completion: 2020-11-08
• First posted: 2020-08-21
• Last updated: 2021-01-07

Locations

1 site across 1 country: Belgium