Effects of Butyrate on Affective Processes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-08

Study Completion Date

2022-12-11

Brief Summary

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

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Detailed Description

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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

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Emotions Stress Fear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participants, investigators, and personnel involved in data analyses are blinded to the intervention. Unblinding occurs after all data has been collected AND analysed.

Study Groups

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Placebo

Placebo (cellulose)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Cellulose

Butyrate

Sodium butyrate

Group Type ACTIVE_COMPARATOR

Butyrate

Intervention Type DIETARY_SUPPLEMENT

Sodium butyrate

Interventions

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Placebo

Cellulose

Intervention Type DIETARY_SUPPLEMENT

Butyrate

Sodium butyrate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Male participants
* Age range 20-40 years
* BMI range 18.5-25
* Dutch or English as native-language

Exclusion Criteria

* previous or current neurological, psychiatric, gastrointestinal or endocrine disorders, or other relevant medical history
* current or recent regular medication use
* previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)
* one or more diagnoses based on the mini-international neuropsychiatric interview
* smoking
* night-shift work
* adherence to vegan or vegetarian diets
* use of pre- or probiotics within one month preceding the study
* use of antibiotics within 3 months preceding the study
* previous experience with one of the tasks used in the study

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes