The Role of Short Chain Fatty Acids in Microbiota-gut-brain Axis

NCT ID: NCT03688854

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-04
• Study Completion Date: 2018-09-15

Brief 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

Emotions; Stress; Fear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Placebo

Placebo are capsules containing cellulose.

Group Type: PLACEBO_COMPARATOR

SCFA mixture

Intervention Type: DIETARY_SUPPLEMENT

Intracolonic administration

SCFA mixture low dose

Encapsulated SCFA mixture in the ratio of 67:6:27 (acetate, propionate, butyrate) equivalent of 10 grams of fiber.

Group Type: EXPERIMENTAL

SCFA mixture

Intervention Type: DIETARY_SUPPLEMENT

Intracolonic administration

SCFA mixture high dose

Encapsulated SCFA mixture in the ratio of 67:6:27 (acetate, propionate, butyrate) equivalent of 20 grams of fiber.

Group Type: EXPERIMENTAL

SCFA mixture

Intervention Type: DIETARY_SUPPLEMENT

Intracolonic administration

Interventions

SCFA mixture

Intracolonic administration

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Male participants
• Age range 20-40 years
• BMI range 18.5-27
• Dutch 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

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Kristin Verbeke

Prof. Dr. Kristin Verbeke

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Verbeke, Prof

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

UZ Leuven/Stresslab

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S60501

Identifier Type: -

Identifier Source: org_study_id