Hunger and Satiety in Anorexia Nervosa (HUSAAN)

October 12, 2016 updated by: René Klinkby Støving, Odense University Hospital

Hunger and Satiety Perception in Patients With Anorexia Nervosa

Anorexia means loss of appetite. But there is disagreement about whether the appetite is changed by the disease anorexia nervosa (AN). Appetite is a subjective essential sense, which is regulated in a complex ensemble between brain, stomach - intestinal system and hormones. As a direct result of malnutrition, there are many somatic complications caused by the disease AN. Several of these complications may in itself affect hunger- and satiety perception. An example of this is delayed gastric emptying. Furthermore, changes in the hormone systems affects the biological "reward system" in the brain, which plays an important role in appetite regulation. There is clearly need for research that could lead to better treatments for AN. Hunger- and satiety perception has only been studied in a few small cross-sectional studies with no clear conclusion.

The purpose of the study is to determine whether a visual analog scale measurement can detect changes in hunger- and satiety perception in a least 30 patients admitted to nutrition for life-threatening severe anorexia nervosa. It may lead to the first step in the development of a simple and inexpensive instrument which may prove to be useful in measuring the impact of new and ongoing treatments of the disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Appetite refers to the desire associated with eating. Both internal and external factors can stimulate appetite. Hunger and satiety are included in appetite regulation. Hunger is related to physiological needs and the commencement of eating. Satiety refers to a state without the urge to eat, where both the onset of satiety and post ingestion satiety are included.

Anorexia is abnormal loss of appetite for food. Anorexia nervosa is an eating disorder characterized by food restriction, despite low weight, leading to speculation about the presence of appetite alterations by weight loss.

AN is a syndrome of unknown etiology which has been well described since 1873, and which occurs most frequently in adolescent women. The syndrome is characterized by distorted body image, and fear of obesity, why low ideal weight is pursued. The disorder occurs in different degrees of severity with secondary endocrine and metabolic changes and disturbances. The symptoms may also include excessive physical activity, abuse of laxatives, or diuretics and self-induced vomiting.

There are multiple medical complications due to the starvation and weight loss in AN, several of which directly may affect appetite, for instance, delayed emptying of the stomach and constipation. Furthermore, compression of duodenum has been observed causing nausea and early satiety.

Hypothalamic hypogonadism is one of the well-known adaptive endocrine alterations in AN due to starvation and exaggerated exercise. Progesterone and testosterone is believed to stimulate appetite and eating, in a manner mediated centrally, selectively increasing the number of meals.

Moreover, AN patients have significantly higher levels of ghrelin, growth hormone (GH) and cortisol and significantly lower leptin, compared with partially recovered AN patients and constitutionally thin subjects.

Hunger and satiety are subjective sensations which may be influenced by sensory factors and palatability, including taste, smell and texture. A recent study suggested that patients with AN may have an altered perception of olfactory, gustatory stimuli, and reduced perception of bitter stimuli.

Other physiological factors such as, hypothalamic and mesolimbic endocannabinoids, enhance appetite by stimulating neurochemical pathways underlying both homeostatic and rewarding aspects of food intake. Endocannabinoids are involved in food-related reward mechanisms, and there are increasing evidence that these mechanisms are dysregulated in AN patients. Moreover, functional neuroimaging studies have demonstrated decreased food-related stimuli in brain areas of the mesolimbic reward system in AN patients.

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Center for Eating Disorders, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with anorexia nervosa.

Description

Inclusion Criteria:

  • Patients with severe AN admitted to the specialized nutrition unit at Center for Eating disorders at Odense University Hospital are included.

Exclusion Criteria:

  • Patients admitted only for short-term water-electrolyte correction, are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standardized noon meal
Patients with anorexia nervosa during in-patient treatment are rating hunger and satiety on a visual analogue scale before and after a standardized and supervised meal. The meal is "treatment as usual" in a specialized ward. A patient may participate several times, if readmitted.
Dietary supplement: Standardized noon meal
The meal is "treatment as usual" in the specialized somatic stabilization ward for patients with severe anorexia nervosa.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hunger and satiety sensation
Time Frame: 30 minutes
visual analogue scale
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Study Chair: René Stoving, PhD, Odense UH, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (ESTIMATE)

October 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUSAAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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