Anorexia NervosaNCT00946816
The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity
A study testing Nutritional Intervention in people with Anorexia Nervosa and Obesity, run by University of Zurich at 1 site in Switzerland.
Trial summary
Diseases characterized by abnormal low and high body weight are common in the community and are associated with significant morbidity, mortality and health care related costs. Genetic, dietary, social and psychologic factors all play an important part in these conditions; however the central role of gastrointestinal… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anorexia Nervosa, Obesity, Healthy Participants
- What is being tested?
- Nutritional Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Gastroenterology and Hepatology
Zurich, Canton of Zurich, 8091
About this study
Official title: The Effects of Dietary Intervention on Gastrointestinal Motility, Hormonal Feedback, Visceral Sensation and Satiety in Patients With Anorexia Nervosa and Obesity
Diseases characterized by abnormal low and high body weight are common in the community and are associated with significant morbidity, mortality and health care related costs.
Genetic, dietary, social and psychologic factors all play an important part in these conditions; however the central role of gastrointestinal (GI) function and the control of nutrient delivery to the small bowel has not been well described in health or disease.
Read more
We propose that the GI response to feeding varies inversely with body weight. This hypothesis predicts that as body weight increases, the response to a given meal decreases in terms of motility, neurohormonal feedback, sensation and satiety. This provides an attractive explanation for why thin individuals stop eating after a small amount of food (i.e. limited gastric relaxation, rapid gastric emptying, powerful nutrient feedback with early satiety)and, conversely, why obese patients continue to eat even after nutritional requirements have been met (i.e. large gastric relaxation, slow gastric emptying, weak nutrient feedback with delayed satiety).
This project will apply MRI and Breath Tests to assess GI motility, hormonal feedback, visceral sensation and satiety in patients with pathologically low (anorexia nervosa) and high (morbid obesity) body weight and in healthy, normal weight controls.
Participants will include: Group A: normal weight, healthy volunteers (n=24: BMI: 18.5-24.9 kg/m2) Group B: patients with anorexia nervosa (DSMIV criteria and BMI: <16 kg/m2) B1: anorexia restricting type (n=12-20 over 2 years) and B2: anorexia bulimia type (n=20 over 2 years) Group C: patients with morbid obesity (BMI: 30-40 kg/m2) C1: obese (n=20 over 2 years) and C2: obese with DM type II (n=20 over 2 years).
Two studies will be performed
- Cross-sectional study: The effects of a test meal on GI motility, hormonal feedback, visceral sensation and satiety in healthy controls and in patients with anorexia and obesity
- Longitudinal study: The effects of dietary treatment (i.e. weight change) on GI motility, hormonal feedback, visceral sensation and satiety in patients with anorexia and obesity
- Conditions
- Anorexia Nervosa, Obesity, Healthy Participants
- Being tested
- Nutritional Intervention
- Medical subject headings
- Anorexia Nervosa, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional InterventionBehavioural
Nutritional Intervention
| Study group | Role | What they receive |
|---|---|---|
| Anorexia Nervosa | Active comparator | Not described Receives: Behavioral: Nutritional Intervention |
| Obesity | Active comparator | Not described Receives: Behavioral: Nutritional Intervention |
| Healthy volunteers | Active comparator | Not described Receives: Behavioral: Nutritional Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The GI response to a given meal in terms of: motility, neurohormonal feedback, sensation and satiety
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startSep 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Schweizerischer Nationalfonds
- Responsible party
- Sponsor
- Investigators
- Michael Fried, Professor MD, Principal investigator, University Hospital Zurich, Gastroenterology and Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946816
- Sponsor's protocol ID
- SNF 320030_1253331
- Status last verified
- Nov 2012
- First submitted
- 20 Jul 2009
- Last updated
- 14 Nov 2012
- Results posted
- No
Publications
Bluemel S, Menne D, Milos G, Goetze O, Fried M, Schwizer W, Fox M, Steingoetter A. Relationship of body weight with gastrointestinal motor and sensory function: studies in anorexia nervosa and obesity. BMC Gastroenterol. 2017 Jan 5;17(1):4. doi: 10.1186/s12876-016-0560-y.
PubMed 28056812
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Intervention on Gastrointestinal Motility, Hormonal Feedback, Visceral Sensation and Satiety in Patients With Anorexia Nervosa and Obesity
- ClinicalTrials.gov ID
- NCT00946816
- Acronym / sponsor ID
- SNF 320030_1253331
- Conditions
- Anorexia Nervosa, Obesity, Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Schweizerischer Nationalfonds
- Study start
- Sep 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 27 Jul 2009 (estimated)
- 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.
Diseases characterized by abnormal low and high body weight are common in the community and are associated with significant morbidity, mortality and health care related costs.
Genetic, dietary, social and psychologic factors all play an important part in these conditions; however the central role of gastrointestinal (GI) function and the control of nutrient delivery to the small bowel has not been well described in health or disease.
We propose that the GI response to feeding varies inversely with body weight. This hypothesis predicts that as body weight increases, the response to a given meal decreases in terms of motility, neurohormonal feedback, sensation and satiety. This provides an attractive explanation for why thin individuals stop eating after a small amount of food (i.e. limited gastric relaxation, rapid gastric emptying, powerful nutrient feedback with early satiety)and, conversely, why obese patients continue to eat even after nutritional requirements have been met (i.e. large gastric relaxation, slow gastric emptying, weak nutrient feedback with delayed satiety).
This project will apply MRI and Breath Tests to assess GI motility, hormonal feedback, visceral sensation and satiety in patients with pathologically low (anorexia nervosa) and high (morbid obesity) body weight and in healthy, normal weight controls.
Participants will include: Group A: normal weight, healthy volunteers (n=24: BMI: 18.5-24.9 kg/m2) Group B: patients with anorexia nervosa (DSMIV criteria and BMI: <16 kg/m2) B1: anorexia restricting type (n=12-20 over 2 years) and B2: anorexia bulimia type (n=20 over 2 years) Group C: patients with morbid obesity (BMI: 30-40 kg/m2) C1: obese (n=20 over 2 years) and C2: obese with DM type II (n=20 over 2 years).
Two studies will be performed
- Cross-sectional study: The effects of a test meal on GI motility, hormonal feedback, visceral sensation and satiety in healthy controls and in patients with anorexia and obesity
- Longitudinal study: The effects of dietary treatment (i.e. weight change) on GI motility, hormonal feedback, visceral sensation and satiety in patients with anorexia and obesity
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa | Active comparator | Behavioral: Nutritional Intervention |
| Obesity | Active comparator | Behavioral: Nutritional Intervention |
| Healthy volunteers | Active comparator | Behavioral: Nutritional Intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- pregnancy
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 |
|---|---|---|
| Nutritional InterventionNutritional Intervention | Behavioural | Anorexia Nervosa, Healthy volunteers, Obesity |
Primary outcome
The GI response to a given meal in terms of: motility, neurohormonal feedback, sensation and satiety
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
- Derived from this study: PubMed 28056812Bluemel S, Menne D, Milos G, Goetze O, Fried M, Schwizer W, Fox M, Steingoetter A. Relationship of body weight with gastrointestinal motor and sensory function: studies in anorexia nervosa and obesity. BMC Gastroenterol. 2017 Jan 5;17(1):4. doi: 10.1186/s12876-016-0560-y.
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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.
Michael Fried, Professor MD principal investigator
University Hospital Zurich, Gastroenterology and Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Intervention in people with Anorexia Nervosa and Obesity, run by University of Zurich at 1 site in Switzerland.
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 0 inclusion and 1 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: finished, as of the sponsor's last update on 14 Nov 2012. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The GI response to a given meal in terms of: motility, neurohormonal feedback, sensation and satiety (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00946816, which also lists 1 linked publication.
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 14 Nov 2012.