Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Short-Chain Fatty AcidsAcute StressMicrobiota-Gut-Brain-AxisNeuroepigenetics[11C] MartinostatFunctional magnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

HDAC expression
Brain HDAC expression will be quantified using the PET radiotracer \[11C\]Martinostat before and after the intervention
Throughout study completion, on average 2 years
Brain response to stress
Brain response (brain oxygenation level-dependent signals) to a fMRI-adapted stress task will be measured before and after intervention
Throughout study completion, on average 2 years

Secondary Outcomes (9)

Brain metabolite concentration
Throughout study completion, on average 2 years
Serum short-chain fatty acid levels
Throughout study completion, on average 2 years
Salivary cortisol response to stress
Throughout study completion, on average 2 years
Cytokine levels
Throughout study completion, on average 2 years
C-reactive protein levels
Throughout study completion, on average 2 years
+4 more secondary outcomes

Other Outcomes (10)

Fecal gut microbiota profile
Throughout study completion, on average 2 years
Perceived Stress Scale (PSS)
Throughout study completion, on average 2 years
Gastrointestinal Symptom Rating Scale (GSRS)
Throughout study completion, on average 2 years
+7 more other outcomes

Study Arms (2)

Short-Chain Fatty Acids

EXPERIMENTAL

SCFAs will be delivered directly to the colon using pH-dependent colon delivery capsules

Other: Short-Chain Fatty Acids

Placebo

PLACEBO COMPARATOR

Colon-delivery capsules of microcrystalline cellulose

Other: Placebo

Interventions

Short-Chain Fatty AcidsOther

Colon-delivery capsules of Short-Chain Fatty Acids will be administered in a ratio of 60:20:20, thus 150 mmol of acetate, 50 mmol of propionate and 50 mmol of butyrate equivalent to 20g of fibers, once daily, one week

Short-Chain Fatty Acids

PlaceboOther

Microcrystalline Cellulose will be used as placebo, one daily, one week

Placebo

Eligibility Criteria

Age18 Years - 45 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
Proficiency in English and/or Dutch

Sponsors & Collaborators

Universitaire Ziekenhuizen KU Leuven
Otherlead

Study Sites (1)

UZ/KU Leuven

Leuven, 3000, Belgium

Lukas Van Oudenhove, MD, PhDCONTACT

MeSH Terms

Interventions

Fatty Acids, Volatile

Intervention Hierarchy (Ancestors)

Fatty AcidsLipids

Study Officials

Lukas Van Oudenhove, MD, PhD
KU Leuven
PRINCIPAL INVESTIGATOR
Annalena Fuchs, MSc
KU Leuven
STUDY DIRECTOR
Kristin Verbeke, Pharm, PhD
KU Leuven
PRINCIPAL INVESTIGATOR
Boushra Dalile, PhD
KU Leuven
PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Van Oudenhove, MD, PhD

CONTACT

+32 16 33 01 47 lukas.vanoudenhove@kuleuven.be

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Participants, investigators, and personnel involved in data analyses are blinded to the intervention. Unblinding occurs after all data has been collected and analysed.
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD, PhD

Study Record Dates

First Submitted

August 6, 2024

First Posted

August 9, 2024

Study Start

September 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brain Responses to Short-Chain Fatty Acid Intervention

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Other Outcomes (10)

Study Arms (2)

Short-Chain Fatty Acids

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Other Outcomes (10)

Study Arms (2)

Short-Chain Fatty Acids

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations