Effects of Butyrate on Affective Processes

NCT04722549 | Completed

• 1 other identifier: S60501- Exp 2
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The effects of butyrate on psychobiological processes are examined in a sample of healthy volunteers.

Conditions

Emotions; Stress; Fear

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, on average 1 year and 5 months

Secondary Outcomes (12)

• Stress sensitivity (subjective)

  through study completion, on average 1 year and 5 months

• Cortisol awakening response

  through study completion, on average 1 year and 5 months

• Fear

  through study completion, on average 1 year and 5 months

• Fear (subjective)

  through study completion, on average 1 year and 5 months

• Positive and Negative Affect Schedule (PANAS)

  through study completion, on average 1 year and 5 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (cellulose)

Dietary Supplement: Placebo

Butyrate

ACTIVE COMPARATOR

Sodium butyrate

Dietary Supplement: Butyrate

Interventions

Placebo DIETARY_SUPPLEMENT

Cellulose

Placebo

Butyrate DIETARY_SUPPLEMENT

Sodium butyrate

Butyrate

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male participants
• Age range 20-40 years
• BMI range 18.5-25
• Dutch or English as native-language

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

UZ Leuven/Stresslab

Leuven, I Am Not in the U.S. Or Canada, 3000, Belgium

Location

MeSH Terms

Interventions

Butyrates

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Kristin Verbeke, Prof

  kristin.verbeke@kuleuven.be

  PRINCIPAL INVESTIGATOR

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: Prof. Dr. Kristin Verbeke

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 25, 2021
• Study Start: February 8, 2021
• Primary Completion: December 11, 2022
• Study Completion: December 11, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

BE (1)