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Completed

NCT Number: NCT05627583

Nutritional Rehabilitation and Markers of Severity in Anorexia Nervosa

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaliora, Andriana C.

Athens, Attica, Greece

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Antibiotic treatment before and during the study

Treatment and study plan

rehabilitation

Other

Hospitalized patients with AN under treatment for rehabilitation

Primary outcomes

  1. Increase in Body Weight

    Time frame: Up to three months during inpatient rehabilitation

    Increase in body weight as a marker of rehabilitation

Secondary outcomes

  1. Metabolic recovery in patients with AN

    Time frame: Up to three months during inpatient rehabilitation

    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.

  2. Changes in ghrelin levels

    Time frame: Up to three months during inpatient rehabilitation

    As a marker of appetite ghrelin blood levels are measured.

  3. Changes in blood metals and metalloids

    Time frame: Up to three months during inpatient rehabilitation

    Different metals and metalloids in plasma are evaluated applying ICP-MS.

  4. Changes in leptin levels

    Time frame: Up to three months during inpatient rehabilitation

    Changes in leptin levels

  5. Changes in IL-6 levels

    Time frame: Up to three months during inpatient rehabilitation

    Changes in IL-6 levels

  6. Changes in serum oxidisability

    Time frame: Up to three months during inpatient rehabilitation

    Changes in serum oxidisability

  7. Changes in EDE-Q

    Time frame: Up to three months during inpatient rehabilitation

    The EDE-Q is a marker of disorder severity.

  8. Changes in EAT-total

    Time frame: Up to three months during inpatient rehabilitation

    EAT-total is a marker of disorder severity.

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • Attikon Hospital
  • National Hellenic Research Foundation
  • National and Kapodistrian University of Athens
  • Sismanoglio General Hospital

Registry information

Official study title

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

Acronym: EAT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 25, 2022
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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