Effects of Butyrate on Affective Processes
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Emotions
- Fear
- Stress
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Participants, investigators, and personnel involved in data analyses are blinded to the intervention. Unblinding occurs after all data has been collected AND analysed.Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 20 years and 40 years
- Gender
- Only males
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 s...
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.
Tracking Information
- NCT #
- NCT04722549
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kristin Verbeke, Prof kristin.verbeke@kuleuven.be
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