Brain Responses to Short-Chain Fatty Acid Intervention

NCT06546683 | Not Yet Recruiting

• 1 other identifier: S68154
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, triple-blind, placebo-controlled study on the effect of colon-delivered short-chain fatty acids (SCFAs) on neural responses to stress and neuroepigenetics.

Conditions

Stress; Healthy Volunteers

Keywords

Short-Chain Fatty Acids; Acute Stress; Microbiota-Gut-Brain-Axis; Neuroepigenetics; [11C] Martinostat; Functional 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

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

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 Acids OTHER

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

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• Access to a -18°C freezer (i.e. ordinary household freezer)
• Male participants
• Age 18-45 years
• BMI 18.5-25 kg/m2

You may not qualify if:

• Participant has a history of previous or current neurological, psychiatric, gastrointestinal or endocrine disorder
• Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol (as assessed by medical staff on the research team)
• Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the study
• Participation in an interventional Trial with an investigational medicinal product (IMP) or device
• Current or recent (3-month) medication use (especially antibiotics, cardiovascular drugs, steroids, non-steroid anti-inflammatory drugs, centrally effective drugs)
• Current or recent (1-month) infection (e.g. common cold, influenza, COVID-19, etc.)
• Recent (1-month) vaccination (e.g. flu shot, SARS-COV-2 vaccine, etc)
• Smoking
• Night-shift work
• Adherence to special diets (e.g. vegan, vegetarian, weight-loss, lactose-free, gluten- free, etc.)
• Use of pre- or probiotics within one month preceding the study
• Previous experience with any of the tasks used in the study (not including questionnaires)
• Neuroimaging contraindications
• If the participant invokes that he does not want to be informed of eventual pathology that might be found during imaging (invokes the "right not to know")

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ/KU Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

Fatty Acids, Volatile

Intervention Hierarchy (Ancestors)

Fatty Acids; Lipids

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 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will become available upon publication with no time limitations.
• Access Criteria: The data will be publicly available.

Locations

BE (1)