Anorexia NervosaDiANaNCT06866301
Active Lifestyle Intervention in Anorexia Nervosa: a Comprehensive Study
A study testing Progressive Resistance Exercise in people with Anorexia Nervosa, run by University of Oviedo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Progressive Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2022to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
- Healthy Controls:
- Meet the physical activity recommendations of the World Health Organization for the age group and sex.
Who cannot join
- 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) .
- Healthy Controls:
- Suffer from metabolic, pulmonary or cardiovascular disease
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- Suffer from serious organic disease
- Taking prescribed medications while participating in the project
- Have contraindications to perform the proposed assessments or intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DiANa Project: Uncovering the Relationship Between MircroRNA Expression, Gut Microbiota and Prognosis in Patients with Anorexia Nervosa.
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:
Read more
- 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Progressive Resistance Exercise
- Keywords
- Anorexia Nervosa, microRNA, Gut Microbiota, Exercise, Physical Fitness, Mental Health, Body Composition
- Medical subject headings
- Anorexia Nervosa, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Resistance ExerciseBehavioural
The exercise program will have a duration of 10 weeks. It will be divided in two phases: conditioning phase and training phase. During the conditioning phase (2-3 weeks), participants will learn exercise techniques, work on their interoceptive awareness and perform same exercises at a lower intensity to prepare the muscles for the next phase. In the training phase, the intensity will be moderate starting at approximately 60% of capacity, with a frequency of three days per week and continuous adjustment (progression) based on the participant's improvements. Each session will include a warm-up and cool-down of approximately 10 minutes. The central part of the session will be in the form of a circuit and will include 6 large muscle group exercises using a combination of machine exercises following the PPL (push, pull and legs) model and 3 core strengthening exercises.
| Study group | Role | What they receive |
|---|---|---|
| AN-Intervention | Experimental | Patient enrolled in the exercise intervention group Receives: Behavioral: Progressive Resistance Exercise |
| AN-Control | No intervention | Patient enrolled in the non-exercise group |
| H-Control | No intervention | Healthy controls in the non-exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of microRNA profile from baseline to week 12 and week 24
microRNAs are epigenetic markers that are sensitive to lifestyle interventions. A possible change is an improved profile after exercise intervention. microRNAs are measured in reads per million
Measured: Baseline, week 12 and week 24
Change of gut microbiota profile from baseline to week 12 and week 24
Gut microbiota is a group of bacteria that are sensitive to lifestyle interventions, stress and other environmental factors. A possible change is an improved profile after exercise intervention. Microbiota is measured in reads per million
Measured: Baseline, week 12 and week 24
Change of Eating Disorders Examination Questionnaire (EDE-Q) scores from baseline to week 12 and week 24
The EDE-Q provides a global score and four subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) derived from a 7-point Likert scale, where 0 indicates no symptoms or concerns and 6 indicates the most severe symptoms or concerns. Higher scores represent greater severity of eating disorder pathology
Measured: Baseline, week 12 and week 24
Change of muscle strength from baseline to week 12 and week 24
Muscle strength is a physical fitness marker that is sensitive to lifestyle interventions. A possible change is an improved muscle strength after exercise intervention. Strength is measured in kilograms, Newtons, Watts, velocity (meters/second) or time (seconds).
Measured: Baseline, week 12 and week 24
Change of muscle content from baseline to week 12 and week 24
Muscle content is a marker of health that is sensitive to lifestyle interventions and is measured with BioImpedance Analysis. A possible change is an improved muscle content after exercise intervention. Muscle content is measured in Kilograms or squared centimeters.
Measured: Baseline, week 12 and week 24
Secondary outcomes (7)
Change of the anthropometric profile from baseline to week 12 and week 24
Anthropometric measurements server as a marker of body composition which are sensitive to lifestyle interventions. A possible change is an improved anthropometric profile after exercise intervention. Anthropometric variables are measured in kilograms (body weight), meters (height), centimeters (circumferences), millimeters (skinfolds).
Measured: Baseline, week 12 and week 24
Change of fat content from baseline to week 12 and week 24
Fat content is a health marker that is sensitive to lifestyle interventions. A possible change is an improved fat content after exercise intervention and is measured with BioImpedance Analysis. Fat content is measured in kilograms or millimeters.
Measured: Baseline, week 12 and week 24
Change of functional capacity from baseline to week 12 and week 24
Functional capacity is a marker that indicates the capacity of the body to supply oxygen and nutrients to the muscles for energy production. It is sensitive to lifestyle interventions. A possible change is an improved functional capacity after exercise intervention. Functional capacity is measured in milliliters per kilogram per minute, Liters per minute, meters per second, beats per minute, or time (minutes).
Measured: Baseline, week 12 and week 24
Change of Physical Activity Levels from baseline to week 12 and week 24
Physical Activity Levels are markers of health and well-being sensitive to lifestyle interventions. A possible change is an improved physical activity level profile after exercise intervention. Physical activity levels are measured in minutes/day, kcals, counts or % of time during the day/week.
Measured: Baseline, week 12 and week 24
Change of Beck Depression Inventory 2 (BDI-2) from baseline to week 12 and week 24
The Beck Depression Inventory-2 (BDI-2) is a self-report questionnaire designed to assess the severity of depressive symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, where 0 indicates no symptom severity and 3 indicates the most severe level of the symptom. The total score ranges from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline, week 12 and week 24
Change of Brief Symptom Inventory (BSI) scores from baseline to week 12 and week 24
The Brief Symptom Inventory (BSI) is a self-report questionnaire designed to assess distress across three symptom dimensions (depression, anxiety, and somatization) and a global severity index. Higher scores reflect greater levels of distress or severity of symptoms.
Measured: Baseline, week 12 and week 24
Change of The Short Form-36 Health Survey (SF-36) scores from baseline to week 12 and week 24
The Short Form-36 Health Survey (SF-36) is a self-report questionnaire designed to measure health-related quality of life across eight domains (Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue, Emotional Well-being, Social Functioning, Pain, and General Health). Scores for each domain, as well as a physical and mental component summary score, are derived on a scale from 0 to 100, where 0 indicates the worst possible health or functioning and 100 indicates the best possible health or functioning. Higher scores reflect better health and quality of life.
Measured: Baseline, week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start25 May 2022
- Primary completionJul 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866301
- Sponsor's protocol ID
- SV-PA-21-AYUD/2021/58376
- Acronym
- DiANa
- Status last verified
- Jan 2025
- First submitted
- 4 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the sensitive nature of the data collected in this clinical trial, which involves individuals with eating disorders, including minors and young adults, we have decided not to share individual participant data (IPD). Eating disorders are highly stigmatized conditions, and although the data do not contain personally identifiable and health-related information, the population in the area is reduced so we want to prevent potential privacy risks, even with de-identification efforts. Additionally, the inclusion of underage participants necessitates strict adherence to ethical and legal protections regarding their confidentiality. Ensuring the privacy and well-being of this vulnerable population is our utmost priority, aligning with ethical guidelines and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiANa Project: Uncovering the Relationship Between MircroRNA Expression, Gut Microbiota and Prognosis in Patients with Anorexia Nervosa.
- ClinicalTrials.gov ID
- NCT06866301
- Acronym / sponsor ID
- DiANa / SV-PA-21-AYUD/2021/58376
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, microRNA, Gut Microbiota, Exercise, Physical Fitness, Mental Health, Body Composition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AN-Intervention | Experimental | Behavioral: Progressive Resistance ExercisePatient enrolled in the exercise intervention group |
| AN-Control | No intervention | –Patient enrolled in the non-exercise group |
| H-Control | No intervention | –Healthy controls in the non-exercise group |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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) .
- Healthy Controls:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Resistance ExerciseThe exercise program will have a duration of 10 weeks. It will be divided in two phases: conditioning phase and training phase. During the conditioning phase (2-3 weeks), participants will learn exercise techniques, work on their interoceptive awareness and perform same exercises at a lower intensity to prepare the muscles for the next phase. In the training phase, the intensity will be moderate starting at approximately 60% of capacity, with a frequency of three days per week and continuous adjustment (progression) based on the participant's improvements. Each session will include a warm-up and cool-down of approximately 10 minutes. The central part of the session will be in the form of a circuit and will include 6 large muscle group exercises using a combination of machine exercises following the PPL (push, pull and legs) model and 3 core strengthening exercises. | Behavioural | AN-Intervention |
Primary outcome
Change of microRNA profile from baseline to week 12 and week 24
Time frame: Baseline, week 12 and week 24
microRNAs are epigenetic markers that are sensitive to lifestyle interventions. A possible change is an improved profile after exercise intervention. microRNAs are measured in reads per million
Change of gut microbiota profile from baseline to week 12 and week 24
Time frame: Baseline, week 12 and week 24
Gut microbiota is a group of bacteria that are sensitive to lifestyle interventions, stress and other environmental factors. A possible change is an improved profile after exercise intervention. Microbiota is measured in reads per million
Change of Eating Disorders Examination Questionnaire (EDE-Q) scores from baseline to week 12 and week 24
Time frame: Baseline, week 12 and week 24
The EDE-Q provides a global score and four subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) derived from a 7-point Likert scale, where 0 indicates no symptoms or concerns and 6 indicates the most severe symptoms or concerns. Higher scores represent greater severity of eating disorder pathology
Change of muscle strength from baseline to week 12 and week 24
Time frame: Baseline, week 12 and week 24
Muscle strength is a physical fitness marker that is sensitive to lifestyle interventions. A possible change is an improved muscle strength after exercise intervention. Strength is measured in kilograms, Newtons, Watts, velocity (meters/second) or time (seconds).
Change of muscle content from baseline to week 12 and week 24
Time frame: Baseline, week 12 and week 24
Muscle content is a marker of health that is sensitive to lifestyle interventions and is measured with BioImpedance Analysis. A possible change is an improved muscle content after exercise intervention. Muscle content is measured in Kilograms or squared centimeters.
7 secondary outcomes
Change of the anthropometric profile from baseline to week 12 and week 24
Time frame: Baseline, week 12 and week 24
Change of fat content from baseline to week 12 and week 24
Time frame: Baseline, week 12 and week 24
Change of functional capacity from baseline to week 12 and week 24
Time frame: Baseline, week 12 and week 24
Change of Physical Activity Levels from baseline to week 12 and week 24
Time frame: Baseline, week 12 and week 24
Change of Beck Depression Inventory 2 (BDI-2) from baseline to week 12 and week 24
Time frame: Baseline, week 12 and week 24
Change of Brief Symptom Inventory (BSI) scores from baseline to week 12 and week 24
Time frame: Baseline, week 12 and week 24
Change of The Short Form-36 Health Survey (SF-36) scores from baseline to week 12 and week 24
Time frame: Baseline, week 12 and week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No. Given the sensitive nature of the data collected in this clinical trial, which involves individuals with eating disorders, including minors and young adults, we have decided not to share individual participant data (IPD). Eating disorders are highly stigmatized conditions, and although the data do not contain personally identifiable and health-related information, the population in the area is reduced so we want to prevent potential privacy risks, even with de-identification efforts. Additionally, the inclusion of underage participants necessitates strict adherence to ethical and legal protections regarding their confidentiality. Ensuring the privacy and well-being of this vulnerable population is our utmost priority, aligning with ethical guidelines and data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Resistance Exercise in people with Anorexia Nervosa, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of microRNA profile from baseline to week 12 and week 24 (time frame: Baseline, week 12 and week 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.