The Role of Short-chain Fatty Acids in Malnutrition on Stress, Eating Behavior, and Nutritional State

NCT06064201 | Unknown

• 1 other identifier: S66404
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

anorexia nervosa; short-chain fatty acids; gut-brain axis; microbiota; stress response; eating behavior; gut microbiome; food choice; Trier Social Stress Test; randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• Salivary cortisol response following TSST

  Changes in salivary cortisol levels in response to acute laboratory stress (Trier Social Stress Test).

  Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)

• Restrictive food choices during Food Choice Task

  Food choices made under stress are measured through the food choice task, focusing on the proportion of high-fat food items chosen over the reference item.

  Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)

• Nutritional status (BMI)

  Nutritional status of participants determined by calculating Body Mass Index (BMI) from recurrently measured weight

  Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention) and at the follow-up visit (12 weeks following the start of the intervention)

Secondary Outcomes (14)

• Neuroendocrine Measures (salivary alpha amylase)

  Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)

• Neuroendocrine Measures (ACTH)

  Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)

• Subjective stress in relation to TSST

  Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)

• Subjective stress appraisal in relation to TSST

  Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)

• Subjective anxiety in relation to TSST

  Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)

Other Outcomes (7)

• Short-chain fatty acid levels

  Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention)

• Fecal gut microbiota profile

  Baseline (at hospital admission and before intervention) and post-intervention (following six weeks of intervention) and at the follow-up visit (12 weeks following the start of the intervention)

• Gastrointestinal Symptoms

  Self-reported questionnaires are completed at the baseline visit (at hospital admission and before intervention), three weeks into the intervention, post intervention (following six weeks of intervention) and at the follow-up visit (12 weeks following

Study Arms (2)

Short-chain fatty acids (SCFAs)

EXPERIMENTAL

SCFAs will be delivered directly to the colon using pH-dependent colon delivery capsules (CDCs).

Other: Short-chain fatty acids (SCFAs)

Microcrystalline cellulose

PLACEBO COMPARATOR

Placebo capsules

Other: Placebo

Interventions

Short-chain fatty acids (SCFAs) OTHER

The SCFAs mixture contains acetate, butyrate, and propionate in a ratio of 60:20:20, and the total daily amount of SCFAs is equivalent to the fermentation of 10g of arabinoxylan oligosaccharides. Participants will be asked to consume these capsules spread at four intervals throughout the day. The nursing staff will distribute the capsules to the participants individually, supervise their intake, and monitor adherence by capsule count.

Short-chain fatty acids (SCFAs)

Placebo OTHER

To serve as a placebo, microcrystalline cellulose will be included in the same type of CDCs.

Microcrystalline cellulose

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

UZ/KU Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (1)

• Quagebeur R, Dalile B, Raes J, Van Oudenhove L, Verbeke K, Vrieze E. The role of short-chain fatty acids (SCFAs) in regulating stress responses, eating behavior, and nutritional state in anorexia nervosa: protocol for a randomized controlled trial. J Eat Disord. 2023 Oct 26;11(1):191. doi: 10.1186/s40337-023-00917-6.

  PMID: 37884972 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa; Fractures, Stress; Feeding Behavior

Interventions

Fatty Acids, Volatile

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Fractures, Bone; Wounds and Injuries; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Fatty Acids; Lipids

Central Study Contacts

Elske Vrieze, MD PhD

CONTACT

+32 16 34 81 46; elske.vrieze@upckuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor dr.

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: October 3, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

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

Locations

BE (1)