This clinical trial aims to evaluate the therapeutic potential of oral butyric acid supplementation in individuals with anorexia nervosa (AN). T The study will assess whether butyric acid, administered alongside standard multidisciplinary care, improves weight restoration and contributes to overall clinical recovery. The primary objectives are to determine: \- Whether butyric acid enhances weight restoration during the first 3 months of treatment. Participants will be randomly assigned to receive either butyric acid or a placebo for 3 months, in addition to treatment-as-usual, which includes nutritional rehabilitation and cognitive-behavioral therapy. Throughout the study, researchers will monitor: * Changes in body weight and Body Mass Index (BMI) * General and eating-disorder-related psychopathology * Blood-based biomarkers related to inflammation, metabolism, and neuroendocrine function * Gut microbiota composition and metabolites, including short-chain fatty acids A total of 50 participants with AN are expected to be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Daily oral supplementation with 2 capsules of microencapsulated butyric acid (Butyrose®, 550 mg each; total daily dose 1,100 mg) for 3 months, administered in addition to Treatment As Usual (nutritional rehabilitation + cognitive-behavioral therapy).
Daily oral supplementation with 2 placebo capsules matched in appearance and composition (maltodextrins, cellulose, inert excipients), administered for 3 months in addition to Treatment As Usual.
SODc Psichiatria, Azienda Ospedaliero-Universitaria Careggi
Florence, FI, Italy
Weight
Body weight measured in kilograms using a calibrated scale.
Time frame: Baseline and 3 months
Body Mass Index (BMI)
BMI calculated as weight (kg) divided by height (m²). Unit of Measure: kg/m²
Time frame: Baseline and 3 months
Gut Microbiota Composition
Assessment of the relative abundance of bacterial taxa through sequencing at baseline and 3 months. Changes over time will be evaluated to identify shifts in microbial composition and potential alterations in gut balance relevant to anorexia nervosa.
Time frame: Baseline and 3 months
Short-Chain Fatty Acids (SCFAs)
Measurement of SCFA concentrations (e.g., butyrate, acetate, propionate) at baseline and 3 months. Changes in SCFA levels will be used to evaluate alterations in gut microbial metabolic activity over time.
Time frame: Baseline and 3 months
Eating disorder psychopatology - Eating Disorder Examination Questionnaire 6.0 (EDE-Q 6.0; Calugi et al., 2015)
The EDE-Q measures eating-disorder psychopathology across four subscales: Restraint, Eating Concern, Shape Concern, and Weight Concern. Items are scored from 0 to 6. The Global Score is the mean of the four subscales. Higher scores indicate more severe eating-disorder symptoms. Unit of Measure: Units on a scale.
Time frame: Baseline and 3 months
Eating disorder psychopathology - Eating Disorder Inventory - 3 (EDI-3; Clausen et al., 2011)
The EDI-3 evaluates psychological traits associated with eating disorders. It includes subscales such as Drive for Thinness, Bulimia, Body Dissatisfaction, Low Self-Esteem, Emotional Dysregulation, Interoceptive Deficits, Perfectionism, Asceticism, and others. Items are typically scored on 0-4 Likert scales. Higher scores indicate greater psychological dysfunction relevant to EDs. Unit of Measure: Units on a scale.
Time frame: Baseline and 3 months
General psychopathology - Brief Symptom Inventory (BSI); Derogatis & Melisaratos, 1983)
The BSI assesses general psychopathology. It includes the following subscales: Somatization, Obsessive-Compulsive Symptoms, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Items are rated on a 0-4 scale. Higher scores indicate greater overall psychopathology. Unit of Measure: Units on a scale.
Time frame: Baseline and 3 months
Childhood maltreatment - Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein et al., 2003)
The CTQ-SF assesses exposure to childhood maltreatment. It includes five subscales: Emotional Abuse, Physical Abuse, Sexual Abuse, Emotional Neglect, and Physical Neglect. Subscale scores range from 5 to 25; the total score ranges from 25 to 125. Higher scores indicate more severe childhood maltreatment. Unit of Measure: Units on a scale.
Time frame: Baseline
Emotional dysregulation - Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
The DERS measures emotion-regulation difficulties. It includes six subscales: Nonacceptance, Goals, Impulse, Awareness, Strategies, and Clarity. Total scores range from 36 to 180. Higher scores indicate greater difficulties in emotion regulation. Unit of Measure: Units on a scale
Time frame: Baseline and 3 months
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