Nutritional Rehabilitation and Markers of Severity in Anorexia Nervosa

NCT05627583 | Completed

• 1 other identifier: EAT study
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• Increase in Body Weight

  Increase in body weight as a marker of rehabilitation

  Up to three months during inpatient rehabilitation

Secondary Outcomes (8)

• Metabolic recovery in patients with AN

  Up to three months during inpatient rehabilitation

• Changes in ghrelin levels

  Up to three months during inpatient rehabilitation

• Changes in blood metals and metalloids

  Up to three months during inpatient rehabilitation

• Changes in leptin levels

  Up to three months during inpatient rehabilitation

• Changes in IL-6 levels

  Up to three months during inpatient rehabilitation

Study Arms (1)

Anorexia Nervosa (AN)

Anorexia Nervosa patients hospitalized for rehabilitation

Other: Rehabilitation

Interventions

Rehabilitation OTHER

Hospitalized patients with AN under treatment for rehabilitation

Anorexia Nervosa (AN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

13 Males and females with AN who are hospitalized for rehabilitation

You may qualify if:

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

You may not qualify if:

• Antibiotic treatment before and during the study

Sponsors & Collaborators

• Harokopio University: lead
• National and Kapodistrian University of Athens: collaborator
• Sismanoglio General Hospital: collaborator
• Attikon Hospital: collaborator
• National Hellenic Research Foundation: collaborator

Study Sites (1)

Kaliora, Andriana C.

Athens, Attica, Greece

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples are used to extract DNA for NGS

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Andriana C. Kaliora

  Harokopio University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. in Human Nutrition and Foods

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 25, 2022
• Study Start: September 1, 2022
• Primary Completion: October 24, 2023
• Study Completion: December 24, 2023
• Last Updated: May 20, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)