NCT06064201

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

The Role of Short-chain Fatty Acids (SCFAs) in Regulating Stress Responses, Eating Behavior, and Nutritional State in Anorexia Nervosa: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: KU Leuven · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

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 interactions on the acute stress response, eating behavior, and nutritional state in malnourished patients with anorexia nervosa (AN). SCFAs have recently been proposed as crucial mediators of the microbiome's effects on the host. Emerging evidence suggests that SCFAs impact human physiology through various physiological pathways and may regulate stress responses and eating behavior. Method The investigators will conduct a randomized, triple-blind, placebo-controlled trial in 92 AN patients. Patients will receive either a placebo or a mixture of SCFAs (acetate propionate, butyrate) using colon-delivery capsules (CDCs) for six weeks. This clinical trial is an add-on to the standard inpatient psychotherapeutic program focusing on nutritional rehabilitation. Hypotheses The investigators hypothesize that colonic SCFAs delivery will modulate neuroendocrine, cardiovascular, and subjective responses to an acute laboratory psychosocial stress task. As secondary outcome measures, the investigators will assess alterations in restrictive eating behavior and nutritional status, as reflected by changes in body mass index (BMI). Additionally, the investigators will explore changes in microbiota composition, gastrointestinal symptoms, eating disorder psychopathology, and related comorbidities. Discussion The findings of this study can enhance our understanding of how gut microbiota-produced metabolites, particularly SCFAs, impact the stress response and eating behavior of individuals with AN. It has the potential to provide essential insights into the complex interplay between the gut, stress system, and eating behavior and facilitate new therapeutic targets for stress-related psychiatric disorders.

Conditions

• Anorexia Nervosa

Interventions

Type	Name	Description
OTHER	Short-chain fatty acids (SCFAs)	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.
OTHER	Placebo	To serve as a placebo, microcrystalline cellulose will be included in the same type of CDCs.

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2023-10-03
• Last updated: 2023-10-03

Locations

1 site across 1 country: Belgium