EmotionsNCT04722549
Effects of Butyrate on Affective Processes
A study testing Butyrate in people with Emotions and Stress, run by KU Leuven at 1 site in Belgium.
Trial summary
The effects of butyrate on psychobiological processes are examined in a sample of healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- What is being tested?
- Butyrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Feb 2021to 11 Dec 2022
- 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 18.5-25
- Dutch or English 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.
Belgium1 site
UZ Leuven/Stresslab
Leuven, I Am Not in the U.S. Or Canada, 3000
About this study
The effects of butyrate on psychobiological processes are examined in a sample of healthy volunteers.
Read the detailed description
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.
- Being tested
- Placebo, Butyrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Cellulose
ButyrateDietary supplement
Sodium butyrate
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (cellulose) Receives: Dietary Supplement: Placebo |
| Butyrate | Active comparator | Sodium butyrate Receives: Dietary Supplement: Butyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress sensitivity (cortisol)
Induction of cognitive, physical, and social stress using Maastricht Acute Stress Test. Stress hormone cortisol is quantified by gathering multiple saliva samples throughout the stress induction and recovery during both pre-intervention and post-intervention visit.
Measured: through study completion, on average 1 year and 5 months
Secondary outcomes (12)
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 at both pre- and post-intervention visits.
Measured: through study completion, on average 1 year and 5 months
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) on the morning of the pre- and post-intervention visits.
Measured: through study completion, on average 1 year and 5 months
Fear
Exploring fear-related processes (conditioning, extinction, recall, and renewal) by means of a computerised task. Fear response is measured using skin conductance, and a skin conductance response is calculated.
Measured: through study completion, on average 1 year and 5 months
Fear (subjective)
Exploring fear-related processes (conditioning, extinction, recall, and renewal) by means of a computerised task. Fear response is measured subjectively by asking participants to indicate their expectancy of an aversive stimulus.
Measured: through study completion, on average 1 year and 5 months
Positive and Negative Affect Schedule (PANAS)
Assessing ratings on the subscales of PANAS, positive and negative affect. PA subscale scores range between 10-50, with higher scores indicating better outcome.
NA subscale scores range between 10-50, with higher scores indicating worse outcome.
Measured: through study completion, on average 1 year and 5 months
Perceived Stress Scale (PSS)
Assessing ratings on PSS. Scores range between 0-40 with higher scores indicating worse outcome.
Measured: through study completion, on average 1 year and 5 months
Depression, anxiety, and stress scales (DASS-21)
Assessing ratings on the subscales of DASS-21, depression, anxiety, and stress subscales.
Higher scores on these subscales indicates a worse outcome.
Normal (depression: 0 - 4; anxiety: 0 - 3; stress: 0 - 7), Mild (depression: 5 - 6; axiety: 4 - 5; stress: 8 - 9), Moderate (depression: 7 - 10; anxiety: 6 - 7; stress: 10 - 12), Severe (depression: 11 - 13; anxiety: 8 - 9; stress: 13 - 16), Extremely Severe (depression: 14 +; anxiety: 10 +; stress: 17 +).
Measured: through study completion, on average 1 year and 5 months
Leiden Index of Depression Sensitivity-Revised (LEIDS-R)
Assessing ratings on the subscales of LEIDS-R and its total score. This is a self-report on cognitive reactivity comprised of 34 items with six subscales. Hopelessness/suicidality; Acceptance/Coping; Aggression; Control/Perfectionism; Risk Aversion; Rumination.
Measured: through study completion, on average 1 year and 5 months
Gastrointestinal symptom rating scale (GSRS)
Assessing ratings on the subscales of GSRS and its total score. It has 5 subscales (Reflux, Diarrhea, Constipation, Abdominal Pain, and Indigestion Syndrome). Subscale scores range from 1 to 7 and higher scores indicates a worse outcome.
Measured: through study completion, on average 1 year and 5 months
Serum SCFA
Quantification of serum SCFA (μM) at pre- and post-intervention
Measured: through study completion, on average 1 year and 5 months
Faecal SCFA
Quantification of faecal SCFA in samples provided at pre- and post-intervention
Measured: through study completion, on average 1 year and 5 months
Serum BDNF
Quantification of fasting serum BDNF levels (µg/mL)
Measured: through study completion, on average 1 year and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start8 Feb 2021
- Primary completion11 Dec 2022
- Study completion11 Dec 2022
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 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, kristin.verbeke@kuleuven.be
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722549
- Sponsor's protocol ID
- S60501- Exp 2
- Status last verified
- Jan 2023
- First submitted
- 21 Jan 2021
- Last updated
- 4 Jan 2023
- 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Butyrate on Affective Processes
- ClinicalTrials.gov ID
- NCT04722549
- Acronym / sponsor ID
- S60501- Exp 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 11 Dec 2022 (actual)
- Study completion
- 11 Dec 2022 (actual)
- First posted
- 25 Jan 2021 (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 effects of butyrate on psychobiological processes are examined in a sample of healthy volunteers.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (cellulose) |
| Butyrate | Active comparator | Dietary Supplement: ButyrateSodium butyrate |
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 18.5-25
- Dutch or English 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 |
|---|---|---|
| PlaceboCellulose | Dietary supplement | Placebo |
| ButyrateSodium butyrate | Dietary supplement | Butyrate |
Primary outcome
Stress sensitivity (cortisol)
Time frame: through study completion, on average 1 year and 5 months
Induction of cognitive, physical, and social stress using Maastricht Acute Stress Test. Stress hormone cortisol is quantified by gathering multiple saliva samples throughout the stress induction and recovery during both pre-intervention and post-intervention visit.
12 secondary outcomes
Stress sensitivity (subjective)
Time frame: through study completion, on average 1 year and 5 months
Cortisol awakening response
Time frame: through study completion, on average 1 year and 5 months
Fear
Time frame: through study completion, on average 1 year and 5 months
Fear (subjective)
Time frame: through study completion, on average 1 year and 5 months
Positive and Negative Affect Schedule (PANAS)
Time frame: through study completion, on average 1 year and 5 months
Perceived Stress Scale (PSS)
Time frame: through study completion, on average 1 year and 5 months
Depression, anxiety, and stress scales (DASS-21)
Time frame: through study completion, on average 1 year and 5 months
Leiden Index of Depression Sensitivity-Revised (LEIDS-R)
Time frame: through study completion, on average 1 year and 5 months
Gastrointestinal symptom rating scale (GSRS)
Time frame: through study completion, on average 1 year and 5 months
Serum SCFA
Time frame: through study completion, on average 1 year and 5 months
Faecal SCFA
Time frame: through study completion, on average 1 year and 5 months
Serum BDNF
Time frame: through study completion, on average 1 year and 5 months
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 4 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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
kristin.verbeke@kuleuven.be
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butyrate 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 4 Jan 2023. 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 (cortisol) (time frame: through study completion, on average 1 year and 5 months). 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 4 Jan 2023.