Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Anorexia nervosa is an eating disorder in which people keep their body weight at low as possible by restricting the amount of food they eat, vomiting and excessive exercise. It leads to weight loss and a reduction of body mass. A severe loss in body weight can lead to a number of physical problems, such as extreme tiredness, headaches/abdominal pains, poor circulation and females can stop having their periods. These symptoms can only be treated by an adequate increase in weight and distribution of body mass. Available data suggest that during anorexia nervosa, adolescent females seem to lose more fat around their belly (central body fat), while adult females more peripheral fat (fat found elsewhere on the body). When these patients then regain their weight, adult females tend to deposit their newly acquired fat around their belly (central regions) while adolescents regain similar body fat distributions to non-sufferers with no increase in the proportion of belly fat. However, results reported in adolescent females are not consistent and need further investigation, and no comparison has made between adult and adolescent individuals that have undergone the same treatment. The aim of this study is to assess body fat mass and its distribution before and after regaining weight in adolescent and adult individuals with anorexia nervosa treated with same treatment (duration and weight gain rate).

Who can participate?
Female patients with a diagnosis of anorexia nervosa (adolescents 13-19 years, adults 20 years or over)

What does the study involve?
All patients with anorexia nervosa receive the same inpatient treatment based on gaining weight and enhanced cognitive behavioural therapy (CBT-E). Tests were done to measure body composition in all patients.

What are the possible benefits and risks of participating?
The benefits are the improvement of physical, psychological and social status of patients. There is no risk in participating in the study.

Where is the study run from?
Villa Garda Hospital (Italy)

When is the study starting and how long is it expected to run for?
January 2012 to July 2014

Who is the funding the study?
Villa Garda Hospital (Italy)

Who is the main contact?
Dr Marwan El Ghoch

Trial website

Contact information



Primary contact

Dr Marwan El Ghoch


Contact details

Via Monte Baldo
+39 (0)45 620 8611

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Regional fat distribution in adolescent girls and adults with anorexia nervosa: a longitudinal study


Study hypothesis

Available data indicate that adults with anorexia nervosa, but not adolescents, seems to have different body fat distribution with respect to healthy controls before and after immediate weight normalization. However, to date no study compared the effect weight restoration on body fat distribution in adults and adolescents with AN under the same circumstance (identical treatment). It is therefore possible that the differences observed in adults and adolescents with anorexia nervosa might be the results of different modality of nutritional rehabilitation and rate of weight regain. On the basis of this premise, we aimed to study adults and adolescents with anorexia nervosa with the same treatment to investigate if really exists a difference in body fat distribution after immediate weight restoration between the two populations.

Ethics approval

Institutional Review Board of Villa Garda Hospital, 15/12/2011, ref. 02_2012

Study design

Longitudinal study

Primary study design


Secondary study design

Case-control study

Trial setting


Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Anorexia nervosa/body composition


We recruited 66 female patients with a diagnosis of anorexia nervosa and 66 controls of the same age (+ 2 years) with a BMI equivalent to the patients’ BMI after weight restoration for an observational study. The interventions are weight restoration and inpatient cognitive behavioural therapy. All patients received the same treatment. Body composition was measured using dual-energy X-ray absorptiometry (DXA) in anorexia nervosa patients and in healthy controls.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Change in fat masses and their distribution (using DXA) before and after complete weight restoration in AN patients

Secondary outcome measures

Body composition and fat distribution (using DXA) of weight-restored AN patients

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Female patients aged 13 - –50 years (adolescents 13-19 years; adults ≥ 20 years)
2. Diagnosis of anorexia nervosa
3. BMI ≤18.5 kg/m² in adults or BMI percentiles ≤18.5 kg/m² in adolescents at time zero
4. BMI ≥ 18.5 kg/m² in adults or BMI percentiles correspondent to a BMI ≥ 18.5 kg/m² at the end of the treatment

Participant type


Age group




Target number of participants

66 female patients with a diagnosis of anorexia nervosa, and 66 controls of the same age (+ 2 years) with a BMI equivalent to the patients’ BMI after weight restoration.

Participant exclusion criteria

1. Participants that do not satisfy inclusion criteria
2. Participants with active substance abuse, schizophrenia and other psychotic disorders

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Villa Garda Hospital

Sponsor information


Villa Garda Hospital (Italy)

Sponsor details

Via Monte Baldo

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Villa Garda Hospital (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in:

Publication citations

Additional files

Editorial Notes

30/09/2016: Publication reference added.