Clinical trial NCT06866301: Active Lifestyle Intervention in Anorexia Nervosa: a Comprehensive Study
Official title: DiANa Project: Uncovering the Relationship Between MircroRNA Expression, Gut Microbiota and Prognosis in Patients with Anorexia Nervosa.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa
microRNA
Gut Microbiota
Exercise
Physical Fitness
Mental Health
Body Composition
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 48
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to perform a comprehensive analysis of varied health markers and analyze the impact of lifestyle interventions on the prognosis of anorexia nervosa (AN) patients. In addition, this study aims to determine if biomarker analysis can be used as clinical outcomes for disease prognosis long-term and support individualized treatment strategies in female patients with AN during the post-hospitalization phase.

The main questions it aims to answer are:

* What are the miRs and microbiota profiles associated with AN, and how are they linked to other clinical markers?
* How does a lifestyle intervention (exercise with nutritional support) affect biomarkers and clinical markers during the first three months after hospitalization?
* What are the dynamics and associations of biomarkers, including gut microbiota, and how do they relate to critical events during the six months after hospitalization?
* What is the perceived effect of participating in a healthy lifestyle program for patients, families, and professionals involved in the care of these patients?

Participants will:

* Undergo analysis of biomarkers and gut microbiota associated with AN.
* Participate in a lifestyle intervention program involving exercise during the first three months post-hospitalization.
* Provide samples for biomarker and gut microbiota mapping over a six-month period.
* Share feedback on their perceived experience in the lifestyle program through interviews or surveys.

Researchers will compare biomarker and gut microbiota and the effects of the intervention to determine if a lifestyle exercise intervention can lead to better outcomes, and analyze its potential to individualized care strategies.


Eligibility criteria: Inclusion Criteria:

A) Patients:

* Patients with a diagnosis of AN (any subtype)
* BMI \>14kg/m2
* Under treatment at the Regional Eating Disorders Unit at the Area IV and V of the Principality of Asturias
* After acute treatment (total or partial hospitalization or other acute treatment regime following the recommendation of the medical team)

B) Healthy Controls:

- Meet the physical activity recommendations of the World Health Organization for the age group and sex.

Exclusion Criteria:

A) Patients:

* Contraindications to perform the evaluations proposed in this project
* Unmanaged dysfunctional or compulsive exercise
* Other criteria that, in the opinion of the medical team, prioritize the patient's health (i.e., psychological instability, substance abuse) .

B) Healthy Controls:

* Suffer from metabolic, pulmonary or cardiovascular disease
* Suffer from serious organic disease
* Taking prescribed medications while participating in the project
* Have contraindications to perform the proposed assessments or intervention.

Primary outcomes:
measure: Change of microRNA profile from baseline to week 12 and week 24
timeFrame: Baseline, week 12 and week 24
measure: Change of gut microbiota profile from baseline to week 12 and week 24
timeFrame: Baseline, week 12 and week 24
measure: Change of Eating Disorders Examination Questionnaire (EDE-Q) scores from baseline to week 12 and week 24
timeFrame: Baseline, week 12 and week 24
measure: Change of muscle strength from baseline to week 12 and week 24
timeFrame: Baseline, week 12 and week 24
measure: Change of muscle content from baseline to week 12 and week 24
timeFrame: Baseline, week 12 and week 24
Secondary outcomes:
measure: Change of the anthropometric profile from baseline to week 12 and week 24
timeFrame: Baseline, week 12 and week 24
measure: Change of fat content from baseline to week 12 and week 24
timeFrame: Baseline, week 12 and week 24
measure: Change of functional capacity from baseline to week 12 and week 24
timeFrame: Baseline, week 12 and week 24
measure: Change of Physical Activity Levels from baseline to week 12 and week 24
timeFrame: Baseline, week 12 and week 24
measure: Change of Beck Depression Inventory 2 (BDI-2) from baseline to week 12 and week 24
timeFrame: Baseline, week 12 and week 24
measure: Change of Brief Symptom Inventory (BSI) scores from baseline to week 12 and week 24
timeFrame: Baseline, week 12 and week 24
measure: Change of The Short Form-36 Health Survey (SF-36) scores from baseline to week 12 and week 24
timeFrame: Baseline, week 12 and week 24
Other outcomes:
measure: Change of Exercise Dependence Scale-Revised (EDS-R) scores from baseline to week 12 and week 24
timeFrame: Baseline, week 12 and week 24
measure: Perceptions related to exercise resulted from the intervention after 24 weeks
timeFrame: After 24 weeks
Locations:
city: Oviedo
country: Spain
facility: University of Oviedo
state: Asturias
Study officials:
References: