Investigating Sodium Butyrate as Treatment for Anorexia Nervosa

Drug - Sodium butyrate Dose - 1 g once daily Duration - 12 weeks Mode - Oral tablet Adherence monitoring: We'll be asking participants of their adherence during the fortnightly catch-up. We typically ask: - Have you missed any pills in the last fortnight? If so, how many - How many pills do you have left? - If more than 2 pills missed, did you miss these 2 days in a row? - Record any other details The fortnightly catch-up will be conducted by the study doctor or nurse. It will either be a brief 5-10 min phone call or completed in conjunction with a visit to the research site (depending on whether the participant is scheduled to visit the research site that week). Participants will also undertake a nutritional assessment with a dietician at baseline. This assessment should take approximately 30 minutes. Further, those participants who are not already receiving external clinical care will be receiving supportive therapy from trained research staff on a fortnightly basis. This will either be a 30 minute phone or Zoom call or completed in conjunction with a visit to the research site, depending on whether the participant is scheduled to visit the research site that week. Scheduled visits to the research site will take place at Baseline (3 hours), Week 4 (1 hour), Week 8 (1 hour), Week 12. (2.5 hours) There will also be a scheduled follow-up visit to the research site 3 months after having completed the study., which should take approximately 1 hour. Baseline Visit: At the Baseline Visit, the following assessments will be conducted: • The participant will be asked some questions regarding current symptoms of AN, quality of life and readiness to change. • The participant will be required to complete some cognitive tasks that measure thinking (i.e., memory and attention), and decision-making skills. • The participant will be asked to fixate on a fixation cross while being measured using an eye tracker. • A physical examination will be performed by a nurse or the study doctor. • A nutritional assessment, where we ask questions about dietary intake At the end of this session, the study medication will be prescribed. Visits 3 and 4 The participant will be: • asked questions about mood and symptoms • asked about experiences of side effects and any adverse events or health problems since last visit • A physical examination will be performed by a nurse or the study doctor • A blood test to measure liver, kidney, white blood cell, inflammation, glucose, hormones and levels of calcium, magnesium and phosphate .(25 ml) Visit 5: Final Treatment Visit The following assessments will be conducted: • The participant will be asked some questions regarding current symptoms of AN, quality of life and readiness to change. • The participant will be asked whether he/she has experienced any side effects or adverse events. • The participant will be interviewed regarding mood and other symptoms in the past two weeks. • The participant will be asked questions about your quality of life. • The participant will be asked to fixate on a fixation cross while being measured using an eye tracker • A physical examination will be performed by the study doctor. • If completed at baseline, the participant will be required to complete some cognitive tasks that measure thinking (i.e., memory and attention) skills and decision-making skills . • Blood tests and a urine and faecal sample will be collected to assess how symptoms affect biological markers in the blood. These will be compared to the blood tests collected at baseline and throughout the study to assess response to the medication. • A blood test to measure your liver, kidney, white blood cell, inflammation, glucose, hormones and levels of calcium, magnesium, phosphate and zinc (24.5 ml) • A saliva test to measure your cortisol levels (1 x 5 ml). This will be compared to the saliva samples collected at baseline to assess response to the medication. • The participant will be asked to provide a stool sample (can be collected at home or in a private space at the research site, depending on preference) to measure butyrate and zinc levels. • A nutritional assessment, • Cortisol measures will be evaluated via saliva samples (1x 5mL) This will be compared to the saliva samples collected at baseline to assess your response to the medication.