- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03688854
The Role of Short Chain Fatty Acids in Microbiota-gut-brain Axis (SCFA-AP)
October 1, 2018 updated by: Kristin Verbeke, KU Leuven
Effects of Short Chain Fatty Acids on Affective Processes in Humans
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Leuven, Belgium, 3000
- UZ Leuven/Stresslab
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo are capsules containing cellulose.
|
Intracolonic administration
|
Experimental: SCFA mixture low dose
Encapsulated SCFA mixture in the ratio of 67:6:27 (acetate, propionate, butyrate) equivalent of 10 grams of fiber.
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Intracolonic administration
|
Experimental: SCFA mixture high dose
Encapsulated SCFA mixture in the ratio of 67:6:27 (acetate, propionate, butyrate) equivalent of 20 grams of fiber.
|
Intracolonic administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress sensitivity
Time Frame: 1 year
|
Induction of cognitive, physical, and social stress using Maastricht Acute Stress Test.
Stress hormone cortisol is quantified.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress sensitivity (subjective)
Time Frame: 1 year
|
Induction of cognitive, physical, and social stress using Maastricht Acute Stress Test.
Participant rate how much stress, discomfort, and pain they feel on a 10-cm visual analogue scale, with higher values indicating greater stress, discomfort, and pain.
This is done prior to stress induction, in the middle, and at the end.
|
1 year
|
Cortisol awakening response
Time Frame: 1 year
|
Measuring chronic stress by quantifying cortisol in morning samples (5 samples taken form the moment of waking every 15 minutes for 1 hour)
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1 year
|
Fear
Time Frame: 1 year
|
Exploring fear-related processes (conditioning, extinction, recall, and renewal) by means of a computerised task.
Fear response is measured using skin conductance.
|
1 year
|
Fear (subjective)
Time Frame: 1 year
|
Exploring fear-related processes (conditioning, extinction, recall, and renewal) by means of a computerised task.
Fear response is measured subjective reports.
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1 year
|
Attentional bias to emotional stimuli
Time Frame: 1 year
|
Use of a dot-probe task to task attentional bias and change in attentional bias following SCFA vs. placebo supplementation.
This is done via a computerised task, where reaction times are quantified.
|
1 year
|
Perceived Stress Scale (PSS)
Time Frame: 1 year
|
The Perceived Stress Scale (PSS) was devised by Cohen et al. (1983).
It is a 14-item instrument designed to measure the degree to which situations in one's life are appraised as stressful.
It provides a tool for examining issues about the role of appraised stress levels in the aetiology of disease and behavioural disorders.
The scale is designed such that it asks the respondent to rate the frequency of his/her feelings and thoughts related to events and situations that occurred over a selected time-frame.
Notably, high PSS scores have been correlated with higher biomarkers of stress, such as cortisol.
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1 year
|
Positive and Negative Affect Schedule (PANAS)
Time Frame: 1 year
|
The PANAS consists of two 10-item mood scales and was developed to provide brief measures of negative affect (NA) and positive affect (PA).
NA and PA reflect dispositional dimensions, with high-NA epitomized by subjective distress and unpleasurable engagement, and low-NA by the absence of these feelings.
By contrast, PA represents the extent to which an individual experiences pleasurable engagement with the environment.
Respondents are asked to rate the extent to which they have experienced each particular emotion within a specified time period, on a 5-point scale.
The scale points are: 1 'very slightly or not at all', 2 'a little', 3 'moderately', 4 'quite a bit', and 5 'very much'.
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1 year
|
Depression, Anxiety, and Stress Scale (DASS-21)
Time Frame: 1 year
|
The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress.
Each of the three DASS scales contains 14 items, divided into subscales of 2-5 items with similar content.
The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia.
The Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect.
The Stress scale is sensitive to levels of chronic non-specific arousal.
Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week.
Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items.
DASS21 will be used in the present study.
|
1 year
|
Gastointestinal symptom rating scale (GSRS)
Time Frame: 1 year
|
The GSRS (Svellund et al., 1988) is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation.
The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
The reliability and validity of the GSRS are well-documented, and norm values for a general population are available.
|
1 year
|
Microbiota composition
Time Frame: 1 year
|
Analysis of microbiota composition at baseline and after SCFA mixture administration in faecal samples
|
1 year
|
Circulating SCFA
Time Frame: 1 year
|
Measurement of SCFA concentration in blood samples
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kristin Verbeke, Prof, KU Leuven
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2018
Primary Completion (Actual)
September 15, 2018
Study Completion (Actual)
September 15, 2018
Study Registration Dates
First Submitted
September 23, 2018
First Submitted That Met QC Criteria
September 26, 2018
First Posted (Actual)
September 28, 2018
Study Record Updates
Last Update Posted (Actual)
October 2, 2018
Last Update Submitted That Met QC Criteria
October 1, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- S60501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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