The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity

• Register: ClinicalTrials.gov
• Last refreshed on: 19 November 2012
• Main ID: NCT00946816
• Date of registration: 20/07/2009
• Primary sponsor: University of Zurich
• Public title: The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity
• Scientific title: The Effects of Dietary Intervention on Gastrointestinal Motility, Hormonal Feedback, Visceral Sensation and Satiety in Patients With Anorexia Nervosa and Obesity
• Date of first enrolment: September 2010
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00946816
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Switzerland

Contacts

• Name: Michael Fried, Professor MD
• Affiliation: University Hospital Zurich, Gastroenterology and Hepatology

Key inclusion & exclusion criteria

In addition to satisfying specific DSMIV criteria for anorexia nervosa (B1, B2) or WHO
criteria for obesity (C1), or obesity and diabetes mellitus type II (C2), general
inclusion criteria include:

- aged at least 18 and not more than 40 years

- able to communicate well with the investigators and provide written consent

- no physical co-morbidity requiring active treatment, in particular diabetes mellitus,
impairment of liver or kidney function (subjects with diabetes mellitus type II are
eligible for study group C2)

- no psychiatric (DSM IV) disorders limiting the ability to comply with study
requirements

- no use of medications influencing upper GI motility within one week of the study
(i.e. nitrates, prokinetic drugs, macrolide antibiotics). Acid suppression and
antihypertensive medication beta-blocker, calcium channel blockers are acceptable.

- no evidence of current drug or alcohol abuse

- no history of gastrointestinal disease or surgery except appendicectomy or hernia
repair

- females will take a urine pregnancy test before each study, any participant with a
positive pregnancy test will be excluded (females will be investigated always in the
same menstrual phase)

Exclusion criteria:

• pregnancy



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Anorexia Nervosa

Healthy Participants

Obesity

Intervention(s)

Behavioral: Nutritional Intervention

Primary Outcome(s)

The GI response to a given meal in terms of: motility, neurohormonal feedback, sensation and satiety [Time Frame: 2 years]

Secondary ID(s)

SNF 320030_1253331

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Schweizerischer Nationalfonds