Status:
UNKNOWN
The Role of Short-chain Fatty Acids in Malnutrition on Stress, Eating Behavior, and Nutritional State
Lead Sponsor:
KU Leuven
Conditions:
Anorexia Nervosa
Eligibility:
FEMALE
16+ years
Phase:
NA
Brief Summary
This clinical trial aims to test the psychobiological effects of certain substances produced by gut bacteria, known as short-chain fatty acids (SCFAs), in people with anorexia nervosa.
Detailed Description
Objective This protocol proposes investigating the effects of short-chain fatty acids (SCFAs), produced by gut bacterial fermentation of dietary fiber, as mediators of microbiota-gut-brain interaction...
Eligibility Criteria
Inclusion
- Participants are female.
- Participants are at least 16 years of age.
- Participants are Dutch-speaking.
- Participants meet the diagnostic criteria of anorexia nervosa based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5; American Psychiatric Association, 2013). The first time the participant met these criteria was less than seven years ago.
- Participants have a current BMI \< 17,5 (kg/m2).
- Participants are on the waiting list for a psychiatric/psychotherapeutic inpatient treatment program with nutritional rehabilitation on the eating disorder ward of the University Psychiatric Hospital Leuven.
- Participants can access a -18°C home freezer for stool storage.
Exclusion
- Any medical or psychiatric disorder, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
- Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial.
- Substance/alcohol/illegal drug abuse or dependence or evidence for chronic uses of sedatives, drugs and/or sleep medication.
- High caffeine intake (\> 1000 ml coffee daily or equivalent quantities of other caffeine-containing substances).
- Use of pre- or probiotics within the last month before the start of the study.
- Use of antibiotics within the last three months before the start of the study.
- Pregnancy or intention to become pregnant.
- Previous experience with one of the tasks used in the study.
- Use of antipsychotics
- Use of selective serotonin reuptake inhibitors (SSRIs), oral contraceptives, or other drugs is allowed if patients are on a stable dosage for at least four weeks.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06064201
Start Date
November 1 2023
End Date
November 1 2025
Last Update
October 3 2023
Active Locations (1)
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1
UZ/KU Leuven
Leuven, Vlaams Brabant, Belgium, 3000