NCT02932046

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
Last Updated

October 13, 2016

Status Verified

July 1, 2016

Enrollment Period

2.6 years

First QC Date

July 5, 2016

Last Update Submit

October 12, 2016

Conditions

Anorexia NervosaAppetite Disorders

Keywords

eating disordersanorexia nervosaappetite

Outcome Measures

Primary Outcomes (1)

  • Hunger and satiety sensation

    visual analogue scale

    30 minutes

Study Arms (1)

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

Interventions

Standardized noon mealDIETARY_SUPPLEMENT

The meal is "treatment as usual" in the specialized somatic stabilization ward for patients with severe anorexia nervosa.

Standardized noon meal

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with anorexia nervosa.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for eating Disorders, Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (10)

  • 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.

    PMID: 9385628BACKGROUND

  • Stoving 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.

    PMID: 11393567BACKGROUND

  • Westmoreland 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.

    PMID: 26169883BACKGROUND

  • Asarian 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.

    PMID: 23904103BACKGROUND

  • Miljic 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.

    PMID: 16449333BACKGROUND

  • Dazzi 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.

    PMID: 23788398BACKGROUND

  • Stoving 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.

    PMID: 18926548BACKGROUND

  • Monteleone 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.

    PMID: 25646322BACKGROUND

  • Doucet 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.

    PMID: 10918539BACKGROUND

  • Flint 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.

    PMID: 10702749BACKGROUND

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • René Stoving, PhD

    Odense UH, Denmark

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician, Associate Professor, PhD.

Study Record Dates

First Submitted

July 5, 2016

First Posted

October 13, 2016

Study Start

February 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)