Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa

NCT ID: NCT03075371

Last Updated: 2019-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-02-28

Brief Summary

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The goal of the present study is to investigate metabolic gut-brain signaling and the neural correlates of distraction from visual food cues in patients with Anorexia nervosa and healthy controls.

Detailed Description

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Anorexia nervosa (AN) is an eating disorder with high morbidity and lifetime mortality. This eating disorder is mainly characterized by restricted food intake despite a severely low body weight. Given the pronounced self-starvation in AN, the investigation of homeostatic food processing, and its interaction with the reward system is of great scientific interest. Previous research in AN patients has almost exclusively focused on cortical, non-homeostatic (e.g., reward related) food processing. Therefore, the primary aim of the present study is to investigate metabolic gut-brain signaling by focusing on the responsivity of the hypothalamus (i.e., the core region of homeostatic control) and the mesocorticolimbic reward system. A secondary aim is to study the interaction between the mesocorticolimbic reward system and the homeostatic (i.e., hypothalamus) system. Metabolic gut-brain signaling will be assessed by applying a single-blind, randomized, crossover design of intragastric infusion of glucose or water. This approach allows the study of gut-brain signaling to the hypothalamus and the reward system by controlling for sensory aspects of food intake (sight, smell, and taste) in AN patients and healthy controls. Furthermore, we will measure how cognitive strategies to control the desire for visual food cues (top-down control) affect the mesocorticolimbic and hypothalamic systems in AN patients differently than in healthy controls. The interaction between the hypothalamus and the mesocorticolimbic reward system will be investigated using an effective connectivity analysis. Functional magnetic resonance imaging with high spatial resolution and with an optimized protocol for the investigation of the hypothalamus and the mesocorticolimbic reward system will be used to study for the first time homeostatic and non-homeostatic food cue processing in AN patients.

Conditions

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Anorexia Nervosa Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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intragastric glucose administration

Group Type ACTIVE_COMPARATOR

Glucose

Intervention Type OTHER

75 g of glucose dissolved in 300 ml of water

intragastric water administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

300 ml of tap water

Interventions

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Glucose

75 g of glucose dissolved in 300 ml of water

Intervention Type OTHER

Placebo

300 ml of tap water

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients that meet the diagnostic criteria for AN (DSM-V criteria)
* Medically stable patients with a BMI \< 17.5 kg/m² and \> 13 kg/m²; Healthy controls with a BMI \<25 kg/m² and \>18.5 kg/m²
* Over Age of 18 years
* no other lifetimes or current medical illness that could potentially affect appetite or body weight
* right-handedness
* normal or corrected-to-normal vision

Exclusion Criteria

* history of head injury or surgery
* history of neurological disorder
* severe psychiatric comorbidity (psychosis, bipolar disorder, substance abuse)
* smoking
* borderline personality disorder
* current psychotropic medication
* inability to undergo fMRI scanning (e.g. metallic implants, claustrophobia, Pacemakers)
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

University of Heidelberg Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Joe Simon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joe Simon, Dr. Dipl. Psych.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

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University Hospital Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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Stopyra MA, Friederich HC, Lavandier N, Monning E, Bendszus M, Herzog W, Simon JJ. Homeostasis and food craving in obesity: a functional MRI study. Int J Obes (Lond). 2021 Nov;45(11):2464-2470. doi: 10.1038/s41366-021-00920-4. Epub 2021 Aug 17.

Reference Type DERIVED
PMID: 34404907 (View on PubMed)

Stopyra MA, Friederich HC, Monning E, Lavandier N, Bendszus M, Herzog W, Simon JJ. The influence of homeostatic mechanisms on neural regulation of food craving in anorexia nervosa. Psychol Med. 2021 Apr;51(6):1011-1019. doi: 10.1017/S0033291719003970. Epub 2020 Jan 14.

Reference Type DERIVED
PMID: 31931900 (View on PubMed)

Stopyra MA, Friederich HC, Sailer S, Pauen S, Bendszus M, Herzog W, Simon JJ. The effect of intestinal glucose load on neural regulation of food craving. Nutr Neurosci. 2021 Feb;24(2):109-118. doi: 10.1080/1028415X.2019.1600275. Epub 2019 Apr 15.

Reference Type DERIVED
PMID: 30983543 (View on PubMed)

Other Identifiers

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UHeidelbergMedCtr

Identifier Type: -

Identifier Source: org_study_id

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