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

NCT03688854 | Completed

• 1 other identifier: S60501
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotions; Stress; Fear

Outcome Measures

Primary Outcomes (1)

• Stress sensitivity

  Induction of cognitive, physical, and social stress using Maastricht Acute Stress Test. Stress hormone cortisol is quantified.

  1 year

Secondary Outcomes (11)

• Stress sensitivity (subjective)

  1 year

• Cortisol awakening response

  1 year

• Fear

  1 year

• Fear (subjective)

  1 year

• Attentional bias to emotional stimuli

  1 year

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo are capsules containing cellulose.

Dietary Supplement: SCFA mixture

SCFA mixture low dose

EXPERIMENTAL

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

Dietary Supplement: SCFA mixture

SCFA mixture high dose

EXPERIMENTAL

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

Dietary Supplement: SCFA mixture

Interventions

SCFA mixture DIETARY_SUPPLEMENT

Intracolonic administration

Placebo; SCFA mixture high dose; SCFA mixture low dose

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

UZ Leuven/Stresslab

Leuven, 3000, Belgium

Location

Study Officials

• Kristin Verbeke, Prof

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Kristin Verbeke

Study Record Dates

• First Submitted: September 23, 2018
• First Posted: September 28, 2018
• Study Start: January 4, 2018
• Primary Completion: September 15, 2018
• Study Completion: September 15, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-10

Locations

BE (1)