Health TrialsbyHealthPanel

Study of Food Aversion in Patients With Anorexia Nervosa

ConditionAnorexia Nervosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorUniversity of California, San Diego

About this trial

This study uses a meal-challenge protocol to assess if patients with anorexia nervosa show a differential metabolism in response to food in comparison to healthy controls. This study determines how heritable and biochemical factors influence food metabolism in anorexia nervosa in order to develop more effective treatment strategies.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ill AN subjects will meet current Diagnostic and Statistical Manual of Mental Disorders (DSM V) diagnosis of AN, body mass index (BMI) between 11 kg/m² and 17.5 kg/m², or BMI > 17.5 kg/m² with active eating disorder symptoms.

Recovered AN must meet the following criteria at time of study entry: 1) Current or past DSM V diagnosis of AN; 2) BMI between 18.5 kg/m2 and 30 kg/m2; 3) Having maintained a BMI of >18.5 for at least one year.

Control must be healthy adolescent or woman negative on our screen for AN, other Axis I psychiatric illnesses, and having maintained a BMI of between 18.5-30 kg/m² since the age of 18.

Disqualifiers

Exclusion criteria for AN and control subjects include: Organic brain syndrome, schizophrenia and schizoaffective disorder, untreated thyroid disease, renal disease, hepatic disease, and the regular use of fish-oil containing supplements within the last three months of the study. All pregnant and lactating individuals will be excluded.

Trial design

Design model

Parallel

Treatments tested in this trial

  • A breakfast sandwich

    Other intervention

    A meat-based breakfast sandwich

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Anorexia nervosa IOther 1 intervention
Group B: Anorexia nervosa IIOther 1 intervention
Group C: ControlsOther 1 intervention

Trial outcomes

Primary outcomes

1

Change of metabolism biomarker

Percentage change of metabolism marker

Time frame
2 hours
2

Food aversion/anxiety

Percentage change of food aversion/anxiety score

Time frame
2 hours

Secondary outcomes

1

Weight

Change in body weight, kg

Time frame
6 and 12 months
2

Psychopathology

Percentage change in eating disorder psychopathology score

Time frame
6 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

University of Toronto

Collaborator

University of California, Davis

Collaborator

Source ClinicalTrials.gov
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