Nutritional Rehabilitation and Markers of Severity in Anorexia Nervosa (EAT)

Τhe Effect of Nutritional rEhabilitation in Patients With Anorexia Nervosa on Markers Associated With Disease severiTy

The design of this project is a longitudinal trial in patients with Anorexia Nervosa (AN) during in-hospital rehabilitation. Τhe structure of the study, the questionnaires and data protection policy prepared exclusively for our study, have been reviewed and standardised at Institutional Review Boards (Ethics Committees, IRBs,) in Harokopio University of Athens (HUA), Eginition Hospital (EH), Attiko Hospital (AH) and Sismanoglio Hospital (SG).

AN is a psychiatric disorder followed by a psychopathologic concerning of body image and very low body weight due to extreme self-starvation. The exact pathogenesis of AN remains unknown with neurobiological, gastrointestinal, neuroendocrinological, immunological, and genetic factors suspected to be implicated. Furthermore, many metabolic traits, biochemical, biological or/and anthropometrical, are manifested during the maintaining effort of patients to achieve lower body weight. Self-inflicted starvation is the primary and essential causation of the pathological outcomes of the disorder. These outcomes involve all biological systems and organs. The role of the immune system in AN is critical as levels of pro-inflammatory cytokines are increased and the immune system is dysregulated. Other contributors to AN pathogenesis have been proposed, such as increased oxidative stress, dysbiosis of the gut microbiota and altered metabolomic profiles. Treatment options for patients with AN constitutes outpatient and inpatient care accordingly with the severity of the disorder. So far, no biomarker has been strongly proposed as an indicator of the disorder's severity or for assessing the progression of the treatment.

The purpose of this study is to assess and monitor the nutritional rehabilitation of patients with AN during hospitalization treatment. Throughout the treatment's course, nutrition and feeding process, vital signs, psychopathology and biological samples will be gathered and statistical analysis of these data is expected to reveal potential biomarker/s for monitoring the progression of recovery.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Other: Rehabilitation

Detailed Description

Inpatients with AN and non-eating disorders control subjects will be informed about the project outline, objectives and inclusion criteria.

Monitoring of AN patients will take place during in-hospital rehabilitation. Physical exam, lab tests, bioelectrical impedance analysis and psychometric evaluation will take place twice a month. Plasma and serum will be collected and isolated form blood samples, while stool samples will be collected for Nuclear Magnetic Resonance (NMR) metabolomics analysis and in StoolFix tubes for DNA isolation from intestinal microbiota. For serum and plasma isolation, whole blood will be directly and properly drawn into a vacutainer tube and promptly centrifuged. Then, samples will be stored at -80C until further elaboration. Case record forms will be carefully checked for missing data and inconsistencies prior to developing a proper database based on data entry. The highest ethical standards and data protection will be considered.

Assessment will include Medical history, Anthropometric measurements, Vital signs, Nutrition, Subjective Global Assessment-Patient Generated (SGA-PG), Biochemical parameters, Appetite hormones, Inflammation markers, Oxidative stress markers, Composition of intestinal microbiota, Psychometric scales-measurements, Eating Attitude Test-26 (EAT-26), Eating Disorder Examination Questionnaire (EDE-Q), Spielberger State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Body Appreciation Scale (BAS), Sense of Coherence Scale (SOC), Visual Analogue Scale (VAS) for subjective appetite estimation

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece
      • Kaliora, Andriana C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

13 Males and females with AN who are hospitalized for rehabilitation

Description

Inclusion Criteria:

• Patients with Anorexia Nervosa according to the DSM-V (American Psychiatric Association, 2013)

Exclusion criteria:

• Antibiotic treatment before and during the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anorexia Nervosa (AN); Anorexia Nervosa patients hospitalized for rehabilitation	Other: Rehabilitation; Hospitalized patients with AN under treatment for rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in Body Weight	Increase in body weight as a marker of rehabilitation	Up to three months during inpatient rehabilitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic recovery in patients with AN	This study aims to investigate metabolic changes in the gut microbiome of patients with Anorexia Nervosa during nutritional rehabilitation. Stool samples will be collected at multiple time points throughout the in-hospital rehabilitation period. Metabolite concentrations will be analyzed using Nuclear Magnetic Resonance (NMR)-based metabolomics to assess longitudinal alterations associated with metabolic recovery.	Up to three months during inpatient rehabilitation
Changes in ghrelin levels	As a marker of appetite ghrelin blood levels are measured.	Up to three months during inpatient rehabilitation
Changes in blood metals and metalloids	Different metals and metalloids in plasma are evaluated applying ICP-MS.	Up to three months during inpatient rehabilitation
Changes in leptin levels	Changes in leptin levels	Up to three months during inpatient rehabilitation
Changes in IL-6 levels	Changes in IL-6 levels	Up to three months during inpatient rehabilitation
Changes in serum oxidisability	Changes in serum oxidisability	Up to three months during inpatient rehabilitation
Changes in EDE-Q	The EDE-Q is a marker of disorder severity.	Up to three months during inpatient rehabilitation
Changes in EAT-total	EAT-total is a marker of disorder severity.	Up to three months during inpatient rehabilitation

Collaborators and Investigators

• Sponsor: Harokopio University
• Collaborators: National and Kapodistrian University of Athens; National Hellenic Research Foundation; Sismanoglio General Hospital; Attikon University General Hospital, Athens
• Investigators: Study Director: Andriana C. Kaliora, Harokopio University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 24, 2023
• Study Completion (Actual): December 24, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: EAT study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No