EmotionsSCFA-APNCT03688854
The Role of Short Chain Fatty Acids in Microbiota-gut-brain Axis
A study testing SCFA mixture in people with Emotions and Stress, run by KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- What is being tested?
- SCFA mixture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Jan 2018to 15 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants
- Age range 20-40 years
- BMI range 18.5-27
- Dutch as native-language
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- SCFA mixture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCFA mixtureDietary supplement
Intracolonic administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo are capsules containing cellulose. Receives: 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. Receives: 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. Receives: Dietary Supplement: SCFA mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress sensitivity
Induction of cognitive, physical, and social stress using Maastricht Acute Stress Test. Stress hormone cortisol is quantified.
Measured: 1 year
Secondary outcomes (11)
Stress sensitivity (subjective)
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.
Measured: 1 year
Cortisol awakening response
Measuring chronic stress by quantifying cortisol in morning samples (5 samples taken form the moment of waking every 15 minutes for 1 hour)
Measured: 1 year
Fear
Exploring fear-related processes (conditioning, extinction, recall, and renewal) by means of a computerised task. Fear response is measured using skin conductance.
Measured: 1 year
Fear (subjective)
Exploring fear-related processes (conditioning, extinction, recall, and renewal) by means of a computerised task. Fear response is measured subjective reports.
Measured: 1 year
Attentional bias to emotional stimuli
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.
Measured: 1 year
Perceived Stress Scale (PSS)
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.
Measured: 1 year
Positive and Negative Affect Schedule (PANAS)
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'.
Measured: 1 year
Depression, Anxiety, and Stress Scale (DASS-21)
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.
Measured: 1 year
Gastointestinal symptom rating scale (GSRS)
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.
Measured: 1 year
Microbiota composition
Analysis of microbiota composition at baseline and after SCFA mixture administration in faecal samples
Measured: 1 year
Circulating SCFA
Measurement of SCFA concentration in blood samples
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start4 Jan 2018
- Primary completion15 Sep 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmotionsStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
- Investigators
- Kristin Verbeke, Prof, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688854
- Sponsor's protocol ID
- S60501
- Acronym
- SCFA-AP
- Status last verified
- Oct 2018
- First submitted
- 23 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short Chain Fatty Acids on Affective Processes in Humans
- ClinicalTrials.gov ID
- NCT03688854
- Acronym / sponsor ID
- SCFA-AP / S60501
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: SCFA mixturePlacebo are capsules containing cellulose. |
| SCFA mixture low dose | Experimental | Dietary Supplement: SCFA mixtureEncapsulated SCFA mixture in the ratio of 67:6:27 (acetate, propionate, butyrate) equivalent of 10 grams of fiber. |
| SCFA mixture high dose | Experimental | Dietary Supplement: SCFA mixtureEncapsulated SCFA mixture in the ratio of 67:6:27 (acetate, propionate, butyrate) equivalent of 20 grams of fiber. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male participants
- Age range 20-40 years
- BMI range 18.5-27
- Dutch as native-language
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCFA mixtureIntracolonic administration | Dietary supplement | Placebo, SCFA mixture high dose, SCFA mixture low dose |
Primary outcome
Stress sensitivity
Time frame: 1 year
Induction of cognitive, physical, and social stress using Maastricht Acute Stress Test. Stress hormone cortisol is quantified.
11 secondary outcomes
Stress sensitivity (subjective)
Time frame: 1 year
Cortisol awakening response
Time frame: 1 year
Fear
Time frame: 1 year
Fear (subjective)
Time frame: 1 year
Attentional bias to emotional stimuli
Time frame: 1 year
Perceived Stress Scale (PSS)
Time frame: 1 year
Positive and Negative Affect Schedule (PANAS)
Time frame: 1 year
Depression, Anxiety, and Stress Scale (DASS-21)
Time frame: 1 year
Gastointestinal symptom rating scale (GSRS)
Time frame: 1 year
Microbiota composition
Time frame: 1 year
Circulating SCFA
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Verbeke, Prof principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCFA mixture in people with Emotions and Stress, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress sensitivity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.