Anorexia NervosaHUSAANNCT02932046
Hunger and Satiety in Anorexia Nervosa
An observational study of Anorexia Nervosa and Appetite Disorders, run by Odense University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Anorexia Nervosa, Appetite Disorders
- What is being tested?
- Standardized noon meal
- How many people
- 47 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Sep 2016
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with anorexia nervosa.
Who may be able to join
- Patients with severe AN admitted to the specialized nutrition unit at Center for Eating disorders at Odense University Hospital are included.
Who cannot join
- Patients admitted only for short-term water-electrolyte correction, are excluded.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for eating Disorders, Odense University Hospital
Odense, 5000
About this study
Official title: 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.
Read the 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.
- Conditions
- Anorexia Nervosa, Appetite Disorders
- Being tested
- Standardized noon meal
- Keywords
- eating disorders, anorexia nervosa, appetite
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized noon mealDietary supplement
The meal is "treatment as usual" in the specialized somatic stabilization ward for patients with severe anorexia nervosa.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Standardized noon meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hunger and satiety sensation
visual analogue scale
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startFeb 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 Odense University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, René Klinkby Støving, Odense University Hospital
- Investigators
- René Stoving, PhD, Study chair, Odense UH, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932046
- Sponsor's protocol ID
- HUSAAN
- Acronym
- HUSAAN
- Status last verified
- Jul 2016
- First submitted
- 5 Jul 2016
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gull WW. Anorexia nervosa (apepsia hysterica, anorexia hysterica). 1868. Obes Res. 1997 Sep;5(5):498-502. doi: 10.1002/j.1550-8528.1997.tb00677.x. No abstract available.
PubMed 9385628Stoving RK, Hangaard J, Hagen C. Update on endocrine disturbances in anorexia nervosa. J Pediatr Endocrinol Metab. 2001 May;14(5):459-80. doi: 10.1515/jpem.2001.14.5.459.
PubMed 11393567Westmoreland P, Krantz MJ, Mehler PS. Medical Complications of Anorexia Nervosa and Bulimia. Am J Med. 2016 Jan;129(1):30-7. doi: 10.1016/j.amjmed.2015.06.031. Epub 2015 Jul 10.
PubMed 26169883Asarian L, Geary N. Sex differences in the physiology of eating. Am J Physiol Regul Integr Comp Physiol. 2013 Dec;305(11):R1215-67. doi: 10.1152/ajpregu.00446.2012. Epub 2013 Jul 31.
PubMed 23904103Miljic D, Pekic S, Djurovic M, Doknic M, Milic N, Casanueva FF, Ghatei M, Popovic V. Ghrelin has partial or no effect on appetite, growth hormone, prolactin, and cortisol release in patients with anorexia nervosa. J Clin Endocrinol Metab. 2006 Apr;91(4):1491-5. doi: 10.1210/jc.2005-2304. Epub 2006 Jan 31.
PubMed 16449333Dazzi F, Nitto SD, Zambetti G, Loriedo C, Ciofalo A. Alterations of the olfactory-gustatory functions in patients with eating disorders. Eur Eat Disord Rev. 2013 Sep;21(5):382-5. doi: 10.1002/erv.2238. Epub 2013 Jun 20.
PubMed 23788398Stoving RK, Andries A, Brixen K, Flyvbjerg A, Horder K, Frystyk J. Leptin, ghrelin, and endocannabinoids: potential therapeutic targets in anorexia nervosa. J Psychiatr Res. 2009 Apr;43(7):671-9. doi: 10.1016/j.jpsychires.2008.09.007. Epub 2008 Oct 15.
PubMed 18926548Monteleone AM, Di Marzo V, Aveta T, Piscitelli F, Dalle Grave R, Scognamiglio P, El Ghoch M, Calugi S, Monteleone P, Maj M. Deranged endocannabinoid responses to hedonic eating in underweight and recently weight-restored patients with anorexia nervosa. Am J Clin Nutr. 2015 Feb;101(2):262-9. doi: 10.3945/ajcn.114.096164. Epub 2014 Dec 10.
PubMed 25646322Doucet E, Imbeault P, St-Pierre S, Almeras N, Mauriege P, Richard D, Tremblay A. Appetite after weight loss by energy restriction and a low-fat diet-exercise follow-up. Int J Obes Relat Metab Disord. 2000 Jul;24(7):906-14. doi: 10.1038/sj.ijo.0801251.
PubMed 10918539Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083.
PubMed 10702749
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hunger and Satiety Perception in Patients With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02932046
- Acronym / sponsor ID
- HUSAAN / HUSAAN
- Conditions
- Anorexia Nervosa, Appetite Disorders
- Keywords
- eating disorders, anorexia nervosa, appetite
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Oct 2016 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standardized noon meal | – | Dietary Supplement: Standardized noon mealPatients 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with anorexia nervosa.
Key inclusion criteria (1 listed)
- Patients with severe AN admitted to the specialized nutrition unit at Center for Eating disorders at Odense University Hospital are included.
Key exclusion criteria (1 listed)
- Patients admitted only for short-term water-electrolyte correction, are excluded.
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 |
|---|---|---|
| Standardized noon mealThe meal is "treatment as usual" in the specialized somatic stabilization ward for patients with severe anorexia nervosa. | Dietary supplement | Standardized noon meal |
Primary outcome
Hunger and satiety sensation
Time frame: 30 minutes
visual analogue scale
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 13 Oct 2016.
- Background: PubMed 9385628Gull WW. Anorexia nervosa (apepsia hysterica, anorexia hysterica). 1868. Obes Res. 1997 Sep;5(5):498-502. doi: 10.1002/j.1550-8528.1997.tb00677.x. No abstract available.
- Background: PubMed 11393567Stoving RK, Hangaard J, Hagen C. Update on endocrine disturbances in anorexia nervosa. J Pediatr Endocrinol Metab. 2001 May;14(5):459-80. doi: 10.1515/jpem.2001.14.5.459.
- Background: PubMed 26169883Westmoreland P, Krantz MJ, Mehler PS. Medical Complications of Anorexia Nervosa and Bulimia. Am J Med. 2016 Jan;129(1):30-7. doi: 10.1016/j.amjmed.2015.06.031. Epub 2015 Jul 10.
- Background: PubMed 23904103Asarian L, Geary N. Sex differences in the physiology of eating. Am J Physiol Regul Integr Comp Physiol. 2013 Dec;305(11):R1215-67. doi: 10.1152/ajpregu.00446.2012. Epub 2013 Jul 31.
- Background: PubMed 16449333Miljic D, Pekic S, Djurovic M, Doknic M, Milic N, Casanueva FF, Ghatei M, Popovic V. Ghrelin has partial or no effect on appetite, growth hormone, prolactin, and cortisol release in patients with anorexia nervosa. J Clin Endocrinol Metab. 2006 Apr;91(4):1491-5. doi: 10.1210/jc.2005-2304. Epub 2006 Jan 31.
- Background: PubMed 23788398Dazzi F, Nitto SD, Zambetti G, Loriedo C, Ciofalo A. Alterations of the olfactory-gustatory functions in patients with eating disorders. Eur Eat Disord Rev. 2013 Sep;21(5):382-5. doi: 10.1002/erv.2238. Epub 2013 Jun 20.
- Background: PubMed 18926548Stoving RK, Andries A, Brixen K, Flyvbjerg A, Horder K, Frystyk J. Leptin, ghrelin, and endocannabinoids: potential therapeutic targets in anorexia nervosa. J Psychiatr Res. 2009 Apr;43(7):671-9. doi: 10.1016/j.jpsychires.2008.09.007. Epub 2008 Oct 15.
- Background: PubMed 25646322Monteleone AM, Di Marzo V, Aveta T, Piscitelli F, Dalle Grave R, Scognamiglio P, El Ghoch M, Calugi S, Monteleone P, Maj M. Deranged endocannabinoid responses to hedonic eating in underweight and recently weight-restored patients with anorexia nervosa. Am J Clin Nutr. 2015 Feb;101(2):262-9. doi: 10.3945/ajcn.114.096164. Epub 2014 Dec 10.
- Background: PubMed 10918539Doucet E, Imbeault P, St-Pierre S, Almeras N, Mauriege P, Richard D, Tremblay A. Appetite after weight loss by energy restriction and a low-fat diet-exercise follow-up. Int J Obes Relat Metab Disord. 2000 Jul;24(7):906-14. doi: 10.1038/sj.ijo.0801251.
- Background: PubMed 10702749Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083.
- Individual participant dataSharing planned: No
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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.
René Stoving, PhD study chair
Odense UH, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Appetite Disorders, run by Odense University Hospital at 1 site in Denmark.
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 1 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 13 Oct 2016. 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 Denmark. 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?
Hunger and satiety sensation (time frame: 30 minutes). 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 NCT02932046, which also lists 10 linked publications.
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 13 Oct 2016.